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Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

This study was carried out to identify the influence of a shock-absorbing insole, developed by the author for use with high-heeled shoes, on walking. The research design included single-blind randomized parallel groups; namely, a group of 26 participants who wore the shock-absorbing insoles and another group of 26 participants who did not wear the insoles, both carried out walking while wearing 7 cm high-heels. During walking, plantar pressure analysis (via in-shoe plantar pressure measurements), surface electrode electromyography (surface EMG), gait analysis, subjective comfort evaluation, and functional movement (functional mobility) analysis were carried out. In order to compare the two groups, statistical verification (paired t-test) was performed. Wearing the shock-absorbing insole with the high-heeled shoes improved posture stability during walking, as well as increasing the walking speed. In addition, the heel pressure, the pressure of the front foot at the inner side, and the shock ability were decreased. For these reasons, the wearers reported higher comfort. Changes in the muscle activities of the tibialis anterior muscle (TA) and the gastrocnemius muscle (GA) heightened the stability of the ankle joints. Overall, the proposed shock-absorbing insole for use with high-heeled shoes improved the postural stability when walking, as well as improving the distribution of pressure on the soles. A decrease in the diverse side-effects of wearing high-heeled shoes can thus be expected. [ABSTRACT FROM AUTHOR]

Uncontrolled hypertension is a major medical problem leading to many serious health consequences. Enhancing self-management is essential for older adults with uncontrolled hypertension to control blood pressure and improve quality of life. Substantial evidence reveals that health literacy and self-efficacy are the strongest factors influencing self-management behaviors. According to geragogy, older adults require a different kind of education to other age groups. This randomized controlled trial investigated the effects of a Geragogy-Based Self-Management Education Program on health literacy, self-efficacy, and self-management behaviors among older adults with uncontrolled hypertension. One hundred participants who met the inclusion criteria were randomly assigned into experimental (n = 50) and control groups (n = 50). The experimental group received the self-management education program based on the geragogy teaching principle combined with transformative learning theory in addition to routine patient education, whereas the control group received only routine patient education. Data were collected at baseline, at the program end, and one and three months after the end of the program using the Health Literacy Scale, Hypertensive Self-Management Self-Efficacy Scale, and Self-Management Behaviors Scale. Data were analyzed using descriptive statistics, two-way repeated measures ANOVA, and independent sample t-test. The results demonstrated that after receiving the program, the experimental participants had significantly higher health literacy, self-efficacy, and self-management behaviors at all time-points of measurement than before commencing the program and the control participants. The findings of this study indicated a successful self-management education program. Further studies to ensure efficacy of this program are suggested. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for post-stroke depression (PSD). Methods: This study was a single-center, single-blinded, parallel-arm randomized controlled trial. In total, 65 patients with PSD were randomly allocated into EA and sham EA groups. Treatment was administered at GV20, Sishencong, SP6, LR3 and BL18 in both groups. The EA group received EA treatment, while the sham EA group received sham EA treatment using the Park device. Treatment was given three times a week for 4 weeks. The primary outcome was the Hamilton Rating Scale for Depression (HRSD). Secondary outcomes included the Zung Self-Rating Depression Scale (SDS), National Institutes of Health Stroke Scale (NIHSS), Barthel Daily Living Index (BI) and depression scale of traditional Chinese medicine (TCM). Primary and secondary outcomes were assessed at baseline, week 2 after treatment, week 4 after treatment and week 8 of follow-up. Safety assessment was conducted at each visit for 4 weeks of treatment. Results: Significant differences in HRSD, SDS, NIHSS, BI and TCM scale scores were found in the EA group before and after acupuncture treatment (all p < 0.001). Compared with the sham EA group, HRSD scores improved significantly in the EA group at the end of week 2 (F = 31.33, p < 0.001), week 4 (F = 35.58, p < 0.001) and week 8 after treatment onset (F = 25.03, p < 0.001). Similarly, significant improvements were observed in SDS, NIHSS and BI scores. Two participants in the EA group suffered a local hematoma, while no adverse events were reported in the sham EA group. Conclusion: EA appears to be an efficacious and safe treatment for PSD. According to our results, EA may alleviate depressive symptoms, and improve neurological function and capabilities with respect to activities of daily living (ADLs). Trial registration number: ChiCTR-IOR-17012610 (Chinese Clinical Trial Registry). [ABSTRACT FROM AUTHOR]

BACKGROUND Pelvic floor dysfunction (PFD) is mostly caused by childbirth levator ani muscle (LAM) trauma. We hypothesized that platelet-rich plasma (PRP) therapy could support the recovery of LAM in postpartum trauma. METHODS A prospective, single-blind, randomized control study was enrolled in primigravid women from November 2016 to July 2019 at 21 health facilities in Jakarta, Indonesia. Subjects were injected with autologous PRP or placebo at LAM during perineorrhaphy after childbirth. The primary outcome was regaining LAM strength and reducing levator hiatal area at 3 months postpartum. The LAM strength was examined by perineometer (cmH2O), and levator hiatal area was examined by transperineal ultrasound (cm²) at antenatal and 3 months after delivery. Mann--Whitney U test and Wilcoxon signed-rank test were used for analysis. The study was registered in clinicaltrials.gov: NCT03021954. RESULTS Among 240 women, 58 were eligible for analysis. There were no differences in LAM strength and levator ani hiatal area at 3 months postpartum between the two groups (p = 0.583 and p = 0.185, respectively). CONCLUSIONS PRP therapy did not show a difference in the muscle recovery healing process. [ABSTRACT FROM AUTHOR]

To compare the effects of Kinesio taping® (KT) and external electrical stimulation (ES) in addition to pelvic floor muscle exercise (PFME) and sole PFME in women with overactive bladder (OAB). Patients with OAB were randomly allocated into PFME, PFME + KT, PFME + ES groups. All treatments were carried out for 6 weeks. OAB symptoms with voiding diary and Overactive Bladder-Version8 (OAB-V8), pelvic floor muscle strength (PFMS) with perineometer, quality of life with King's Health Questionnaire (KHQ) were assessed before (BT) and after treatment (AT). AT, the perception of improvement was inquired. AT, OAB symptoms and KHQ scores decreased and PFMS improved in all groups (p < 0.05). The intergroup comparisons revealed a further decrease in voids/day, voids/night, OAB-V8, and some KHQ scores, and a further increase in the perception of improvement in the PFME + KT and PFME + ES groups compared to the PFME group (p < 0.05). In the PFME + ES group, there was a further decrease in numbers of incontinence compared to the PFME group, and in severity measures scores compared to the other groups (p < 0.05). KT and external ES in addition to PFME were more effective than PFME alone in the treatment of OAB. Pelvic floor muscle exercise was found to be effective in reducing overactive bladder symptoms and increasing quality of life. Kinesio taping or external electrical stimulation in addition to pelvic floor muscle exercise is more effective in improving overactive bladder symptoms, quality of life, and perception of improvement than pelvic floor muscle exercise alone. Kinesio taping and external electrical stimulation can be used as a complementary application in the treatment of overactive bladder. Pelvic floor muscle exercise, pelvic floor muscle exercise + Kinesio taping, and pelvic floor muscle exercise + electrical stimulation applications should be included in conservative treatment options in patients with overactive bladder to reduce symptoms and cost, and improve quality of life. [ABSTRACT FROM AUTHOR]

Purpose This study was conducted to systematically examine the effect of decision support systems (DSSs) applied to patients with cancer on pain severity. Review methods: Systematic review and meta‐analysis. A search was done on Web of Science, Science Direct, PubMed, ProQuest, EBSCOhost/CINAHL Complete, Scopus, Springer Link, Cochrane Library, and Ovid databases, which covered a period until September 2021. Meta‐analysis of the data was conducted on the CMA 3 software package. Comprehensive reviews were conducted by two independent researchers in line with the PICOS criteria. The study was conducted according to the PRISMA checklist. Findings Five randomized controlled trials with 1.880 participants were included in this systematic review and meta‐analysis. In the study, visits, consultations, simulation of patient outcomes, telephone support, and email applications were employed for periods ranging from 6 weeks to 6 months. The evaluation of the meta‐analysis results indicated that DSSs had positive effects on pain severity in patients with cancer (Hedge's g = 0.22; p < 0.001). Conclusion: The findings of this systematic review and meta‐analysis show that DSSs can be used as an effective and comfortable technological application in reducing the severity of pain in patients with cancer. Clinical relevance: The use of DSSs for pain severity in patients with cancer is an effective method. In line with the findings of this systematic review and meta‐analysis, awareness and knowledge levels of all health disciplines about DSSs will increase. It is believed that the use of DSSs to improve patient‐centered care will be guiding. [ABSTRACT FROM AUTHOR]

Purpose: This study investigated whether UVB-exposed wheat germ oil (WGO) is capable to improving the vitamin D status in healthy volunteers. Methods: A randomized controlled human-intervention trial in parallel design was conducted in Jena (Germany) between February and April. Ultimately, 46 healthy males and females with low mean 25-hydroxyvitamin D (25(OH)D) levels (34.9 ± 10.6 nmol/L) were randomized into three groups receiving either no WGO oil (control, n = 14), 10 g non-exposed WGO per day (– UVB WGO, n = 16) or 10 g WGO, which was exposed for 10 min to ultraviolet B-light (UVB, intensity 500–630 µW/cm2) and provided 23.7 µg vitamin D (22.9 µg vitamin D2 and 0.89 µg vitamin D3) (+ UVB WGO, n = 16) for 6 weeks. Blood was obtained at baseline, after 3 and 6 weeks and analyzed for serum vitamin D-metabolite concentrations via LC–MS/MS. Results: Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D2 after 3 and 6 weeks of intervention. However, the 25(OH)D3 concentrations decreased in the + UVB WGO group, while they increased in the control groups. Finally, the total 25(OH)D concentration (25(OH)D2 + 25(OH)D3) in the + UVB WGO group was lower than that of the non-WGO receiving control group after 6 weeks of treatment. In contrast, circulating vitamin D (vitamin D2 + vitamin D3) was higher in the + UVB WGO group than in the control group receiving no WGO. Conclusion: UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D2 levels but do no improve total serum levels of 25(OH)D of vitamin D-insufficient subjects. Trial registration: ClinicalTrials.gov: NCT03499327 (registered, April 13, 2018). [ABSTRACT FROM AUTHOR]

Over the past decades, a number of complementary treatments for schizophrenia have emerged. One of these is metacognitive training (MCT), which combines the principles of cognitive‐behavioral therapies, cognitive remediation, and psychoeducation into a hybrid approach placing emphasis on increasing metacognitive awareness. The aim of our study was to investigate the efficacy of MCT on symptom severity, and neurocognitive and social cognitive functioning in schizophrenia; also, attention was paid to the assessment of subjective acceptability. Forty‐six patients diagnosed with schizophrenia were included in our single‐blind randomized controlled trial, who were assigned to the intervention or control group. The intervention group was provided standard MCT, while the control group received treatment as usual. We assessed symptom severity and cognitive functions before and after the training, as well as after a 6‐month follow‐up period. Compared to the control group, the intervention group showed improvement in overall symptom severity, and positive and disorganized symptoms. Training participans showed further improvement at the follow‐up assessment. Regarding neurocognitive functions, improvement in visuospatial functions was observed between pre‐ and post‐intervention assessments compared to the control group. Patients showed excellent adherence, and evaluated the training as useful and interesting. In line with the results of previous studies, our results demonstrate the efficacy of MCT on symptom severity in schizophrenia. Improvements in cognitive functions that are closely related to the onset and prevalence of symptoms of schizophrenia were also found. [ABSTRACT FROM AUTHOR]

Aims Tai Chi is a promising exercise option in cardiac rehabilitation to manage coronary heart disease (CHD). Increasing attention was paid on home-based cardiac rehabilitation to improve participation rate, but no study has yet emphasized the effect of home-based Tai Chi. A single-blinded randomized controlled trial is used to examine the effects of a group- plus home-based Tai Chi program on functional health. Methods and results Ninety-eight community-dwelling patients with CHD were randomly assigned to the Tai Chi and control groups. Participants in the Tai Chi group attended 6-week group- plus 6-week home-based Tai Chi program. Outcome measures included physical functions, cardiovascular risk factors, and exercise self-efficacy. Data were collected at baseline, 6-week, 12-week, and 24-week. Intervention effects were analysed using the generalized estimating equation model. Compared with changes in the control group, the intervention group achieved significant improvements in aerobic endurance, lower-body strength, agility and dynamic balance, diastolic blood pressure, and exercise self-efficacy over the 24-week study period (all Ps < 0.05). Intervention adherence was high (79.6% of participants attending >75% of all Tai Chi sessions). Conclusions This Tai Chi program significantly improved the functional health of patients with CHD, indicating that Tai Chi could be taught in group sessions and then continued independently as a home exercise routine for health promotion. [ABSTRACT FROM AUTHOR]

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended. [ABSTRACT FROM AUTHOR]

Background: Prehospital administration of tranexamic acid (TXA) to injured patients is increasing worldwide. However, optimal TXA dose and need of a second infusion on hospital arrival remain undetermined. We investigated the efficacy and safety of the second in-hospital dose of TXA in injured patients receiving 1 g of TXA in the prehospital setting. We hypothesized that a second in-hospital dose of TXA improves survival of trauma patients. Methods: A prospective, double-blind, placebo-controlled randomized, clinical trial included adult trauma patients receiving 1 g of TXA in the prehospital settings. Patients were then blindly randomized to Group I (second 1-g TXA) and Group II (placebo) on hospital arrival. The primary outcome was 24-h (early) and 28-day (late) mortality. Secondary outcomes were thromboembolic events, blood transfusions, hospital length of stay (HLOS) and organs failure (MOF). Results: A total of 220 patients were enrolled, 110 in each group. The TXA and placebo groups had a similar early [OR 1.000 (0.062–16.192); p = 0.47] and late mortality [OR 0.476 (95% CI 0.157–1.442), p = 0.18].The cause of death (n = 15) was traumatic brain injury (TBI) in 12 patients and MOF in 3 patients. The need for blood transfusions in the first 24 h, number of transfused blood units, HLOS, thromboembolic events and multiorgan failure were comparable in the TXA and placebo groups. In seriously injured patients (injury severity score > 24), the MTP activation was higher in the placebo group (31.3% vs 11.10%, p = 0.13), whereas pulmonary embolism (6.9% vs 2.9%, p = 0.44) and late mortality (27.6% vs 14.3%, p = 0.17) were higher in the TXA group but did not reach statistical significance. Conclusion: The second TXA dose did not change the mortality rate, need for blood transfusion, thromboembolic complications, organ failure and HLOS compared to a single prehospital dose and thus its routine administration should be revisited in larger and multicenter studies. Trial registration: ClinicalTrials.gov Identifier: NCT03846973. [ABSTRACT FROM AUTHOR]

Fertility awareness (FA) among young people is low. Fertility awareness interventions have been found to contribute to increase FA in the short-term. The long-term effectiveness of FA interventions on childless and presumed fertile people, committed in a heterosexual relationship and wishing to have children in the near future is not known. In a double-blind parallel randomized controlled trial conducted between 2016 and 2018, 652 childless partnered women were randomized to either watch a 5-min video about fertility (IG: 'Intervention Group') or to not receive any intervention (CG: 'Control Group'). Participants filled out an online questionnaire at the start of the study (and in the IG group immediately before intervention). They then completed the questionnaire after 1 month, 6 months and 1 year. The questionnaire assessed FA and intentions to adopt fertility-protective behaviours. In the IG, FA levels were found to increase at 1 month post-intervention. However, significant interaction effects between group and time were only found for four out of the seven FA variables at the 6-month and 1-year follow-up. No effects were found for: (i) intentions to adopt fertility-protective behaviours; or (ii) desired timing of pregnancy. These results suggest that the fertility video intervention seems to partially increase FA in the long term. Future studies should investigate the effectiveness of different intervention formats with a focus on overcoming high attrition rates. [ABSTRACT FROM AUTHOR]

Although aquatic‐based interventions are increasingly used in the psychiatric rehabilitation services, the effects of this type of community program as an adjuvant therapy for psychosocial problems of people with serious mental illness (SMI) have been under‐explored. This research evaluated the feasibility and outcomes of an occupational therapy program consisting of aquatic‐based activities (AA‐OT program) in the community in Spain. This study is the first randomized controlled trial (RCT) on this topic. This pilot trial was conducted with a sample of 16 adults with SMI who were randomly allocated to the AA‐OT program plus treatment as usual or treatment as usual alone (eight in each group). The AA‐OT program included activation of daily living skills, warm‐up, group activities/tasks, and relaxation. It consisted of two sessions per week over 12 weeks. Outcomes were evaluated at week 0 and 12. A total of 14 participants (87.5%) completed the trial. No adverse events or side‐effects were noted. Comparisons between the two groups on change scores showed that participants in the intervention group showed significant improvements in several outcome measures: psychosocial problems (HoNOS), two health‐related quality of life scales (SF‐36: Physical Functioning and Mental Health), and performance of social activities (Activity and Social Relations scale). Satisfaction with the program was high. In conclusion, the results support the feasibility and potential benefits of this occupational therapy program. 12 weeks of aquatic‐based activities in a group intervention may enhance the outcomes of psychiatric rehabilitation improving the severity of psychosocial problems, patient‐reported health status, and social relations. This community‐based program may be beneficial as a non‐pharmacologic method in the illness management and recovery of people with SMI. The findings from this pilot trial need to be confirmed in a large, fully‐powered RCT. [ABSTRACT FROM AUTHOR]

This pilot randomised controlled trial evaluated the acceptability and feasibility of a psychological intervention to manage severe irritability in children and adolescents. Children with severe irritability (9–14 years; 42% male) were randomised to receive six sessions of Collaborative & Proactive Solutions (CPS) or usual clinical care. The primary outcome was acceptability and feasibility of the intervention (participant enrollment, drop-out, intervention session attendance). Key secondary outcomes assessed 4-month post-randomisation included child irritability, quality of life, executive functioning, parent mental health and family functioning. Twelve children enrolled in the study (52% uptake). All participants in the CPS group attended ≥2 intervention sessions, and one participant in the usual care group was lost to follow-up. Compared to usual care, the CPS group had improvements in child irritability (Effect Size (ES): −0.4), quality of life (ES: 0.4), executive functioning (ES: −0.4), and family functioning (ES: −0.7). It is acceptable and feasible to deliver CPS to severely irritable children and adolescents. Preliminary evidence suggests this non-pharmacological intervention improves important areas of functioning for severely irritable children. The trial was prospectively registered on 11 October 2017 with the Australian New Zealand Clinical Trials Registry (: ACTRN12617001445369). [ABSTRACT FROM AUTHOR]

Caregivers are often encouraged to praise children to reduce externalizing behavior. Although several theoretical perspectives suggest that praise works (e.g., praise reinforces positive behavior), others suggest it may not (e.g., children dismiss praise or experience it as controlling). This longitudinal-observational study examined whether (a) caregivers' praise and children's externalizing behavior were related; (b) an evidence-based parenting program increased caregivers' praise; (c) and increasing praise reduced children's externalizing behavior. Participants (387 caregiver-child dyads) were randomly assigned to a 14-session parenting program (aiming to improve parenting behavior, partly via praise) or a control group. Children (aged 4-8 years, 45% girls) scored at or above the 75th percentile on externalizing behavior problems. Caregivers (91% Caucasian, 85% born in the Netherlands, 50.5% highly educated) were mostly mothers (91%). At baseline, postintervention, and follow-up, we assessed caregivers' labeled and unlabeled praise via in-home observations, and children's externalizing behavior via care-giver-reports and observations. At baseline, caregivers' unlabeled praise was related to more (rather than less) externalizing behavior. The parenting program successfully increased praise and reduced care-giver-reported (but not observed) externalizing behavior; importantly, however, praise did not mediate the program's effect on caregiver-reported externalizing behavior. Although the program did not directly reduce observed externalizing behavior, it did so indirectly via labeled praise. Our results suggest that, although praise and externalizing child behavior are related, praise may not be a key mechanism underlying the effects of the parenting program. If praise has beneficial effects on children's externalizing behavior, these effects are probably limited to labeled praise. [ABSTRACT FROM AUTHOR]

Pediatric obesity is a primary public health concern, and designing effective programs for managing it is of the utmost importance. The objective of this study was to describe the protocol study of a three-arm, parallel, randomized controlled trial aimed at assessing the efficacy of a family-system-based intervention ("ENTREN-F" program) for managing childhood obesity, compared to the "ENTREN" program (no "F" - without specific family-system-based workshop) and a control group (behavioral monitoring). The ENTREN-F program was a multicomponent family-system-based intervention carried out by a multidisciplinary team in the primary health care setting. The program targeted children between 8 and 12 years with overweight and obesity (P ≥ 85th). Parents were actively involved in the process. The contents were designed using the Cognitive Behavioral Therapy (CBT) principles. The program comprised individual behavioral monitoring, a healthy habits workshop for children and their parents, a CBT workshop for children, and a family-system-based workshop for parents, enhancing parental management skills plus family functioning. The trial's primary outcomes included changes in child body mass index (BMI) z-scores, child's psychological well-being, and family functioning over six months. Secondary outcomes included changes in eating behavior, physical activity, self-esteem, parental distress, parental feeding practices, and parental modeling. To our knowledge, this is one of the few randomized controlled trials to assess the efficacy of a multicomponent program that considers health from a comprehensive perspective, trying to improve children's psychological well-being and family functioning besides weight loss. This study, therefore, addresses a gap in the literature. If found to be efficacious, it suggests a new potential health service for translation into National Primary Health Care services in Spain, one of the ten countries with the highest prevalence of obesity in Europe. [ABSTRACT FROM AUTHOR]

A 3-arm, parallel group, randomized clinical trial examines the effect of aromatherapy through inhalation and foot massage on blood pressure and stress response in patients with essential hypertension. Lavender oil reduced blood pressure, heart rate, serum cortisol, and subjective anxiety in hypertensive patients. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of Wen-Luo-Tong Granules (WLT) local administration in the treatment of patients with peripheral neuropathy (PN) induced by chemotherapy or target therapy. Methods: This study is a randomized, double-blinded, and placebo-controlled trial. Seventy-eight patients with PN induced by chemotherapy or target therapy were enrolled from China-Japan Friendship Hospital between July 2019 and January 2020. They were randomly assigned to WLT (39 cases) and control groups (39 cases) using a block randomization method. The WLT group received WLT (hand and foot bath) plus oral Mecobalamin for 1 week, while the control group received placebo plus oral Mecobalamin. The primary endpoint was PN grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE). The secondary endpoints included quantitative touch-detection threshold, neuropathy symptoms, Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20), and Quality of Life Questionnaire-Core30 (QLQ-C30). Results: After treatment, the PN grade in the WLT group was significantly lower than that in the control group (1.00 ± 0.29 vs. 1.75 ± 0.68, P<0.01). The total effective rate in the WLT group was significantly higher than that in the control group (82.05% vs. 51.28%, P<0.01). Compared with the control group, the touch-detection thresholds at fingertips, neuropathy symptom score, QLQ-CIPN 20 (sensory scale, motor scale, autonomic scale, and sum score), and QLQ-C30 (physical functioning, role functioning, emotional functioning, and global health) in the WLT group significantly improved after treatment (P<0.01 or P<0.05). Conclusion: WLT local administration was significantly effective in the treatment of patients with PN induced by chemotherapy or target therapy. (Trial registration No. ChiCTR1900023862) [ABSTRACT FROM AUTHOR]

Lactation problems including delayed onset of lactation, insufficient milk volume, and breast engorgement are important barriers for primiparous mothers because these lead to their early stopping of exclusive breastfeeding. Therefore, a randomized controlled trial was conducted with primiparous mothers to investigate the effects of Southern Thai traditional massage with warm compression on onset of lactation, milk volume, and breast engorgement. A minimized randomization program was used to assign the participants into either 1) Southern Thai traditional massage with warm compression group (n = 21), 2) Southern Thai traditional massage group (n = 21), or 3) control group (n = 21) who received usual care. The instruments used for data collection consisted of a Demographic Data Form, the Onset of Lactation Form, the Milk Volume Recording Form, and the Six-Point Engorgement Scale. Descriptive and inferential statistics were used to analyze the data. The results showed that the onset of lactation was significantly earlier and milk volume was significantly higher in the Southern Thai traditional massage with warm compression group than those in the Southern Thai traditional massage and control groups. Breast engorgement in the Southern Thai traditional massage with warm compression group was significantly lower than those in the Southern Thai traditional massage and control groups. Therefore, the Southern Thai traditional massage with warm compression intervention is effective in improving lactation and breast engorgement. Thus, nurses can use this intervention by teaching nurse-midwife, pregnant women, and relatives to promote the onset of lactation, increase milk volume, and prevent breast engorgement. Further testing with different groups is required before this can be extended to other population groups. [ABSTRACT FROM AUTHOR]

Background: University students are reporting concerning levels of mental health distress and challenges. University mental health service provider initiatives have been shown to be effective in supporting students' mental health, but these services are often resource-intensive. Consequently, new approaches to service delivery, such as web-based and peer support initiatives, have emerged as cost-effective and efficient approaches to support university students. However, these approaches have not been sufficiently evaluated for effectiveness or acceptability in university student populations. Objective: Thus, the overarching goal of this study was to evaluate a mental health service provider--presented versus peer-presented web-based mental health resilience--building video outreach program against a wait-list comparison group. Methods: Participants were 217 undergraduate students (mean age 20.44, SD 1.98 years; 171/217, 78.8% women) who were randomly assigned to one of the intervention groups (mental health service provider--presented: 69/217, 31.8%; peer-presented: 73/217, 33.6%) or the wait-list comparison group (75/217, 34.6%). Participants in the intervention groups were asked to watch 3 brief skill-building videos addressing strategies for building mental health resilience, whereas the comparison group was wait-listed. The mental health service provider--presented and peer-presented video series were identical in content, with presenters using a script to ensure consistency across delivery methods, but the videos differed in that they were either presented by mental health service providers or university students (peers). All participants were asked to complete web-based self-report measures of stress, coping self-efficacy, social support, social connectedness, mindfulness, and quality of life at baseline (time 1), 6 weeks later (time 2, after the intervention), and 1-month follow-up (time 3). Results: Results from a series of 2-way ANOVAs found no significant differences in outcomes among any of the 3 groups. Surprisingly, a main effect of time revealed that all students improved on several well-being outcomes. In addition, results for program satisfaction revealed that both the mental health service provider--presented and peer-presented programs were rated very highly and at comparable levels. Conclusions: Thus, findings suggest that a web-based mental health resilience--building video outreach program may be acceptable for university students regardless of it being mental health service provider--presented or peer-presented. Furthermore, the overall increases in well-being across groups, which coincided with the onset and early weeks of the COVID-19 pandemic, suggest an unexpected pattern of response among university students to the early period of the pandemic. Limitations and barriers as well as research implications are discussed. [ABSTRACT FROM AUTHOR]

Aim: The objective of this study was to investigate the effectiveness of a mindful walking program (MWP) in patients with chronic low back pain (CLBP). Methods: The trial was a two-armed, randomized, controlled single-center open clinical trial. The study was performed in the Outpatient Clinic for Integrative Medicine of the Charite´--Universita¨tsmedizin Berlin. The participants were adults aged 18--65 years with CLBP (‡3 months) and an average low back pain within the past 7 days measured on a visual analog scale (VAS, 0 = no pain, 100 = worst imaginable pain) of at least 40 mm. The patients received either eight weekly MWP sessions or no intervention (control). The primary outcome was the perceived pain intensity assessed with a VAS (0--100mm) after 8 weeks. The secondary outcomes included back function assessed by the Hannover Functional Questionnaire Backache (FFbH-R) and perceived stress assessed by the 14-item Cohen's Perceived Stress Scale (PSS-14). The results were obtained by analysis of covariance adjusted for the respective baseline values. Results: In total, 55 patients were randomized (MWP: n = 29, 82.8% female, mean (--standard deviation) age: 52.5 -- 8.6 years, pain: 56.4 -- 14.1 mm; control: n = 26, 84.6% female, 54.8 -- 7.5 years, pain: 55.4 -- 13.1 mm). After 8 weeks, compared with the control conditions, the MWP was not associated with a statistically significant benefit for pain (VAS), adjusted mean - 9.6 [-22.3 to 3.1], p = 0.136, clinical benefits for back function (FFbH-R), adjusted mean 2.2 [-4.2 to 8.6], p = 0.493, or stress (PSS-14), adjusted mean - 1.6 [-4.8 to 1.6], p = 0.326. Conclusion: In conclusion, compared with no intervention, mindful walking did not significantly improve pain, back function, or perceived stress in patients with CLBP. [ABSTRACT FROM AUTHOR]

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy. ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019). [ABSTRACT FROM AUTHOR]

Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (− 22.0, − 28.0, and − 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD. [ABSTRACT FROM AUTHOR]

Simple Summary: Exercise has emerged as an effective therapeutic modality for improv-ing the health, quality of life and overall survival of individuals with cancer. We assessed the feasibility of implementing a cancer-specific community-based exercise program in advance of a planned large-scale exercise implementation study. Findings supported high interest in, and benefits for fitness outcomes among participants both during and immediately following com-pletion of cancer treatment. Lessons learned from this feasibility trial included the need for clos-er attention to implementation processes, and adaptations to physical fitness and outcome measures to better fit the community setting. Background: There is growing recognition of the importance of reporting preliminary work on the feasibility of a trial. The present study aimed to assess the feasibility of (1) a proposed fitness testing battery, and (2) processes related to the implementation of cancer-specific exercise programming in a community setting. Methods/Design: A randomized controlled implementation feasibility trial was performed in advance of a large-scale implementation study. Eligible participants within 18 months of a cancer diagnosis were randomized to immediate or delayed community-based exercise at YMCA locations in Calgary and Edmonton, Canada for an 8-week period. The primary outcome for the trial was the feasibility of the physical fitness testing battery, defined as a 70% or greater completion rate across the 24-week study period. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to evaluate processes related to implementation of the exercise program across the two sites. Results: Eighty participants were recruited, 73 (91%) completed the 8-week trial, and 68 (85%) completed the 16- and 24-week follow-ups. Sixty participants (75%) completed the full physical fitness test battery at each time point, and 59 (74%) completed the patient-reported outcome measures. Statistically significant between-group differences were found in favor of the exercise group for functional aerobic capacity, upper and lower extremity strength, and symptoms. Differences were found between the sites, however, in completion rates and processes related to program implementation. Discussion: Findings suggest the need for minor adaptations to the physical fitness battery and outcome measures to better fit the community context. While findings support feasibility, context-specific challenges related to implementation processes were identified. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated the effect of the school‐based intervention Charge Your Brainzzz on adolescents' social‐cognitive determinants, sleep hygiene and sleep duration and quality. METHODS: A cluster‐randomized controlled trial was conducted with 972 students from 10 Dutch high schools. Schools were randomly allocated to the intervention (N = 5) or control condition (N = 5). Outcomes were measured with the digital Consensus Sleep Diary and via a digital questionnaire, based on valid measures. Data were collected at baseline (T0), ±1.5 weeks post‐intervention (T1) and ±3 months post‐intervention (T2). Mixed model analyses were performed to estimate the effects on social‐cognitive determinants, sleep hygiene, and sleep outcomes. RESULTS: The intervention increased sleep knowledge post‐intervention (b = 1.91; 95%CI: 1.22‐2.60) and at follow up (b = 1.40; 95%CI: 0.70‐2.10). The intervention was also effective in changing adolescents' attitudes (b = 0.10; 95%CI: 0.01‐0.19) and perceived behavioral control (b = 0.11; 95%CI: 0.01‐0.22) post‐intervention. No positive changes were found regarding subjective norms, behavioral intentions, sleep hygiene, or sleep outcomes. CONCLUSIONS: The intervention improved adolescents' sleep knowledge, attitude, and perceived behavioral control. To significantly impact sleep health, theoretically sound and systematically developed interventions are needed which take into account the interplay between sleep, sleep‐related behaviors, and adolescents' social and physical environment. CLINICAL TRIAL REGISTRATION: Trial name: Evaluation of the school‐based intervention Charge Your Brainzzz promoting sleep in adolescents; URL: https://doi.org/10.1186/ISRCTN36701918; ID: ISRCTN36701918. [ABSTRACT FROM AUTHOR]

Objectives: To determine if Cognitive Orientation to Occupational Performance was effective in improving performance and transfer of motor learning in children with developmental coordination disorder (with/without attention deficit hyperactivity disorder); and whether outcomes were maintained three months post-intervention. Design: Randomized waitlist-control trial (ClinicalTrials.gov ID: NCT02597751) Setting: BC Children's Hospital, Vancouver, Canada Subjects: Thirty-seven children with developmental coordination disorder and 41 children with co-occurring attention deficit hyperactivity disorder (all 8–12 years), randomized to treatment or waitlist groups. Interventions: One-hour of intervention once weekly for 10 weeks. Main Measures: (1) Canadian Occupational Performance Measure to measure self-perceived performance of motor goals (10-point scale); (2) Performance Quality Rating Scale to measure therapist-observed movement quality (10-point scale); and (3) Bruininks-Oseretsky Test of Motor Proficiency – 2nd ed. to measure overall motor skill ability/transfer of motor learning (percentile). Results: Both groups showed significant improvement (p < 0.001) in motor performance (developmental coordination disorder: pre: 2.7 ± 2.2, post: 7.0 ± 1.0; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 2.3 ± 1.7, post: 7.0 ± 1.5) and movement quality (developmental coordination disorder: pre: 3.0 ± 1.5, post: 6.3 ± 1.7; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 3.0 ± 1.9, post: 5.7 ± 2.3). Three months after treatment, children maintained their gains, but only children with developmental coordination disorder showed transfer of learning to overall motor skills (pre:12 ± 15, post:12 ± 12, follow-up:14 ± 20, p < 0.001). Conclusion: Intervention was similarly effective for children with developmental coordination disorder with/without attention deficit hyperactivity disorder in achieving and maintaining functional motor goals, but only children with developmental coordination disorder showed transfer of learning to other motor skills. [ABSTRACT FROM AUTHOR]

Objective: To study the long-term effectiveness of case-management rehabilitation intervention on vocational reintegration of patients after myocardial infarction (MI). Design: Blinded simple randomization was used to construct an intervention and control groups that were followed up for two years. Subjects and setting: 151 patients, aged 50.3 ± 5.9 years, who experienced uncomplicated MI and were enrolled in a cardiac rehabilitation program were recruited. Interventions: included an early referral to an occupational physician, tailoring an occupational rehabilitation program, based on individual patient needs, coordination with relevant parties, psychosocial intervention, intensive follow-up sessions during a two-year follow-up. Main measures: Return to work within six months of hospitalization and maintenance of employment at one and two years of follow-up. Results: Return-to-work (RTW) rate in the intervention group was 89% and nearly all maintained employment at one year of follow-up (92%) and two years of follow-up (87%). Moreover, almost all of them returned to and maintained their previous jobs. The corresponding figures were: 98%, 94% and 98%, respectively. The figures for the RTW and employment maintenance for the control group were: 74%, 75%, and 72%, respectively. Only about 75%, in this group kept their previous job. The case-management intervention was associated with increased odds of maintaining employment at follow-up of one year (OR = 5.89, 95% CI 1.42–24.30) and two years (OR = 3.12, 95% CI 1.01–10.03). Conclusions: The extended case-management rehabilitation intervention had a substantial positive impact on both the RTW of MI patients and their maintenance of employment at one and two years of follow-up. Trial Registration: This trial is registered at US National Institutes of Health #NCT04934735. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to examine the effects of visual art therapy (VAT) on cognition, psychological and functional ability of people with mild cognitive impairment (MCI), and low education. Methods A single-blinded randomized controlled trial was conducted among 127 older adults with MCI, mean age 73.6 years, and level of education in years, median (range) = 0 (0–9). The intervention group received 12 VAT sessions over 6 weeks. The control group received 6 health education sessions. The outcomes measures at baseline, immediately postintervention, at 3-month, and 6-month follow-up included global cognitive functions, depression, mental well-being, and instrumental activities of daily living functions. Results The intervention group demonstrated greater improvement than the control group in global cognition (β = 2.56, 95% confidence interval [CI] = 1.16, 3.97, p <.001, standardized mean difference [SMD] = 0.75) and depression (β = −2.01, 95% CI = −3.09, −0.93, p <.001, SMD = −0.93) immediately postintervention. The effects on cognitive functions were sustained at 3 and 6 months follow-up. The differential effect of VAT on mental well-being and functional ability compared to health education were undetectable. Discussion VAT can improve cognitive functions and mood status of older adults with MCI who have no or low education. Clinical Trials Registration Number: PACTR201901731800445. This trial was registered with Pan African Clinical Trial Registry: www.pactr.org. [ABSTRACT FROM AUTHOR]

Background The obesogenic environment of Western countries raises questions about its current management. Some clinical studies have explored hypnosis, although the current state of knowledge does not lead to definitive conclusions about its efficacy. Objectives We assessed the impact of Ericksonian hypnosis and self-hypnosis on disinhibition of eating in adults with obesity and high food impulsivity levels, compared with standard nutritional education. Methods From September 2014 to July 2015, adults with BMI (in kg/m2) of 30–40 and a high disinhibition score [>8 on the Three Factor Eating Questionnaire (TFEQ-51)] were included in a randomized controlled trial. The control and hypnosis groups received the same standard nutrition education in 8 workshops. In the hypnosis group, subjects had 8 sessions of hypnosis combined with training in self-hypnosis. Disinhibition (primary outcome) and other scores from the TFEQ-51 as well as anthropometric, food intake, cardiometabolic, and physical activity variables were collected at inclusion and at 8 mo. Results Of 82 randomly assigned adults, 70 participated in all sessions; 80 participated in ≥1 session and were included in the main analysis (hypnosis group, n  = 41; control group, n  = 39). After 8 mo of follow-up, disinhibition scores adjusted for baseline values were lower in the hypnosis group, with a mean between-group difference of 4.2 (95% CI: 2.8, 5.5; P  < 0.001); 67.7% of adults in the hypnosis group had normalized their disinhibition (compared with 11.1% in control; P  < 0.0001). Differences for weight (1.8 kg; 95% CI: −0.1, 3.7 kg; P  = 0.052), BMI (0.8; 95% CI: 0.1, 1.4; P  = 0.028), susceptibility to hunger score (2.2; 95% CI: 1.0, 3.3; P  < 0.001), and its 2 subscales also favored the hypnosis group. Conclusions In the management of adults with obesity and a high disinhibition score, hypnosis and self-hypnosis can significantly improve the deep mechanisms of eating behaviors and seem to have a beneficial effect on weight loss. This trial was registered at clinicaltrials.gov as NCT02292108. [ABSTRACT FROM AUTHOR]

Background Intrauterine exposure to maternal vitamin D status <50 nmol/L of serum 25-hydroxyvitamin D [25(OH)D] may adversely affect infant body composition. Whether postnatal interventions can reprogram for a leaner body phenotype is unknown. Objectives The primary objective was to test whether 1000 IU/d of supplemental vitamin D (compared with 400 IU/d) improves lean mass in infants born with serum 25(OH)D <50 nmol/L. Methods Healthy, term, breastfed infants (Montréal, Canada, March 2016–2019) were assessed for serum 25(OH)D (immunoassay) 24–36 h postpartum. Infants with serum 25(OH)D <50nmol/L at 24–36 h were eligible for the trial and randomly assigned at baseline (1 mo postpartum) to 400 (29 males, 20 females) or 1000 IU/d (29 males, 20 females) of vitamin D until 12 mo. Infants (23 males, 18 females) with 25(OH)D ≥50 nmol/L (sufficient) formed a nonrandomized reference group provided 400 IU/d. Anthropometry, body composition (DXA), and serum 25(OH)D concentrations were measured at 1, 3, 6, and 12 mo. Results At baseline, mean ± SD serum 25(OH)D concentrations in infants allocated to the 400 and 1000 IU/d vitamin D groups were 45.8 ± 14.1 and 47.6 ± 13.4, respectively; for the reference group it was 69.2 ± 16.4 nmol/L. Serum 25(OH)D concentration increased on average to ≥50 nmol/L in the trial groups at 3–12 mo. Lean mass varied differently between groups over time; at 12 mo it was higher in the 1000 IU/d vitamin D group than in the 400 IU/d group (mean ± SD: 7013 ± 904.6 compared with 6690.4 ± 1121.7 g, P = 0.0428), but not the reference group (mean ± SD: 6715.1 ± 784.6 g, P = 0.19). Whole-body fat mass was not different between the groups over time. Conclusions Vitamin D supplementation (400 or 1000 IU/d) during infancy readily corrects vitamin D status, whereas 1000 IU/d modestly increases lean mass by 12 mo. The long-term implications require further research. This trial was registered at clinicaltrials.gov as NCT02563015. [ABSTRACT FROM AUTHOR]

Introduction: In heart transplant recipients, nonadherence is associated with higher risk of morbidity and mortality. Research Question: Can a psychoeducational intervention enhance adherence to medical recommendations? Design: We randomized 200 patients awaiting heart transplantation on the high urgency wait list to a manualized psychoeducational intervention or standard care. Follow-up continued to three years after transplantation. Primary endpoint was adherence to immunosuppressive medication, assessed at 3, 6, 12, 24, and 36 months posttransplant. Secondary endpoints were barriers to adherence during follow-up and clinical outcomes, including cardiac rejection within the first postoperative year and postoperative 3-year mortality. Results: Fifty patients died before or within the first 3 months of transplantation. The primary endpoint was analyzed in 66 patients in the intervention group and 66 in the control group. Both study groups showed almost maximal adherence to immunosuppressive medication throughout follow-up, with no significant time x treatment interaction (P>0.99). Likewise, there was no significant time x treatment interaction (P =0.41) on barriers to adherence. The percentage of patients with International Society for Heart and Lung Transplantation standard grade 1 and 2 rejection was in the intervention and control groups 82.5% and 78.7%, respectively, and 8.8% and 13.1%, respectively, without significant differences between study groups (P =0.75). Considering all randomized and transplanted patients in the intervention group (N=85) and control group (N=87), postoperative 3-year mortality was 29.4% and 27.6%, respectively (P =0.82). Conclusions: Adherence to immunosuppressive medication was high, even without a complex, manualized psychoeducational intervention. The intervention had no significant positive impact on cardiac rejection and mortality. [ABSTRACT FROM AUTHOR]

Background: The study carries the aim to compare the clinical efficacy and economic outcomes of using barbed suture closure versus conventional closure for wounds after posterior long-segment lumbar surgery. Methods: One hundred and eighty-one patients undertaking posterior long-segment lumbar surgery participated in the prospective randomized controlled trial study to receive either barbed suture wound closure (n = 91) or conventional suture closure (n = 90). Outcome measures included operating room time (ORT), wound closure time, length of incision, length of hospital stay (LOS), 90-day readmission rates, wound complications of dehiscence and infection, and costs. Results: Barbed suture group was related with significantly lower ORT (P = 0.036), wound closure time (P < 0.001) and average wound closure time (P < 0.001), and significantly lower wound complication rates (dehiscence and infection) (P = 0.031). No significant differences were found when compared with conventional suture group in terms of length of incision (P = 0.086), length of hospital stay (P = 0.174), readmission rates up to 90 days after the surgical procedure (P = 0.232) and costs (P = 0.205). Conclusion: The study suggested the knotless barbed suture technique outperformed the conventional suture in shortening operating room time, wound closure time and average wound closure time, and reducing wound complication rates. [ABSTRACT FROM AUTHOR]

Summary: Background: Few randomized controlled trial (RCT) interventions targeted children's early risk behaviours using telephone or short message service (SMS) support. Objective: To evaluate the effectiveness of telephone or SMS early intervention focusing on mothers' behaviours starting from late pregnancy to improve BMI, and eating and screen time behaviours of children aged 2 years in comparison with the control group. Methods: A 3‐arm RCT was conducted in Australia, 2017–2019. Two arms involved the interventions using nurse‐led telephone or SMS support, delivered in nine stages from late pregnancy to age 2 years. The third arm was control. The primary outcome was children's objectively measured BMI and BMI z‐score at 2 years. Secondary outcomes included child eating and screen time behaviours as reported by parents at 2 years. Results: At 2 years, 797 mother–child dyads (69%) completed the telephone survey with 666 (58%) completing weight and height measurements. The study found no statistically significant difference in BMI between the groups. The mean BMI for telephone support was 16.93 (95% CI: 16.73 to 17.13), for SMS 16.92 (95% CI: 16.73 to 17.11) or for control 16.95 (95% CI: 16.73 to 17.16) with a difference of −0.02 (95% CI: −0.31 to 0.27, p = 0.907) in telephone versus control, and a difference of −0.03 (95% CI: −0.30 to 0.24, p = 0.816) in SMS versus control. Telephone support was associated with higher odds of no bottle at bedtime (adjusted odds ratio [AOR]: 2.99; 95% CI: 2.01 to 4.47), family meals (AOR: 2.05; 95% CI: 1.26 to 3.33), drinking from a cup (AOR: 1.89; 95% CI: 1.24 to 2.88), less screen time (<1 h/day) (AOR: 1.56; 95% CI: 1.10 to 2.23) and not eating dinner in front of the TV (AOR: 1.50; 95% CI: 1.09 to 2.06). SMS support was also associated with higher odds of no bottle at bedtime (AOR 2.30, 95% CI: 1.58 to 3.33) than the control. Conclusion: The telephone or SMS support intervention had no significant effects on BMI, but was effective in increasing no bottle use at bedtime. Telephone support showed more effects than SMS on reducing screen time and eating behaviours. [ABSTRACT FROM AUTHOR]

BACKGROUND: The effects of stretching exercises in fibromyalgia (FM) deserves further study. OBJECTIVE: To evaluate the effectiveness of a Physical Self-Care Support Program (PSCSP), with emphasis on stretching exercises, in the treatment of FM. METHODS: Forty-five women with FM were randomized to the PSCSP (n = 23) or to a control group (n = 22). The PSCSP consisted of weekly 90-minute learning sessions over 10 weeks, providing instructions on wellness, postural techniques, and active stretching exercises to be done at home. The control group was monitored through 3 medical appointments over 10 weeks and included in a waiting list. The primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), the Visual Analogue Scale (VAS) for pain, and the Sit and Reach Test (SRT) at the end of the study. RESULTS: Nineteen and 21 patients completed the trial in PSCSP and control groups, respectively. After 10 weeks, the PSCSP group showed significantly better FIQ (difference between adjusted means, - 13.64, 95% CI, - 21.78 to - 5.49, P = 0.002) and SRT scores (7.24 cm, 3.12 to 11.37, P = 0.001) than the control group, but no significant difference in pain VAS (- 1.41, - 3.04 to 0.22, P = 0.088). Analysis using multiple imputation (MI) and delta-adjusted MI for missing outcomes rendered similar results. CONCLUSIONS: A PSCSP emphasizing stretching exercises significantly improved FIQ and SRT scores, and may be a helpful therapy for FM. [ABSTRACT FROM AUTHOR]

Aim: To test whether soft‐type block bone substitute used for guided bone regeneration (GBR) of peri‐implant defects leads to a different dimension of the augmented hard tissue than particulate bone substitute. Materials and Methods: In 40 patients, 40 two‐piece dental implants were placed >2 months after tooth extraction. Following random allocation, 20 peri‐implant bone dehiscences were grafted with a soft‐type block made of synthetic biphasic calcium phosphate (BCP) + collagen and 20 bone dehiscences with particulate BCP. All the sites were covered with a collagen membrane stabilized with titanium pins. Immediately after wound closure and after 6 months, the horizontal dimension (HD) of the augmented hard tissue was measured at the level of implant shoulder using cone beam computed tomography. During re‐entry at 6 months, the defect fill was clinically assessed. Results: At 6 months, the median HD measured 1.15 mm (mean: 1.31 mm) in the soft‐block group and 0.93 mm (mean: 1.05 mm) in the particulate group (p =.6). At 6 months, 7.1% of contained defects and 61.9% of non‐contained defects showed an incomplete vertical defect fill. Conclusions: Soft‐type block of BCP + collagen used for GBR of peri‐implant defects did not differ from particulate BCP regarding the dimension of the augmented hard tissue after 6 months of healing. [ABSTRACT FROM AUTHOR]

Objective: To determine the clinical effectiveness of adding virtual reality via the Nintendo Wii console and its Wii Balance Board to physiotherapy treatment in patients with total hip arthroplasty. Design: Randomized controlled trial. Setting: Clinical Hospital San Borja Arriaran, Santiago, Chile. Participants: A total of 73 patients over 50 years of age with total hip arthroplasty were randomly allocated to two groups. Interventions: The control group (n = 37) received 6 weeks of physiotherapy treatment; the intervention group (n = 36) received the same treatment plus virtual reality exercises with the Nintendo Wii console. Outcome measures: The two groups were assessed at baseline and after the 6 weeks of treatment. The primary outcome assessed was the function with the WOMAC questionnaire. The secondary outcomes were the Berg Balance Scale, distance covered with the six-minute walk test, and difference in weight load on the lower extremities. Results: A total of 73 patients, 37 patients in the control group (20 women; mean age of 70.9 ± 9.16 years) and 36 patients in the intervention group (18 women; mean age of 70.39 ± 9.02 years) were analyzed. At the end of the treatment, the difference between groups for the total WOMAC score was −10.4 points (p = 0.00), 4.7 points (p = 0.00) for the Berg Balance Scale, and 45.2 mt (p = 0.00) for the six-minute walk test All differences were in favor of the intervention group. Conclusions: In the short term, the addition of virtual reality via the Nintendo Wii and its Wii Balance Board platform showed statistically significant differences in the function of patients with total hip replacement, but these differences were not minimally clinically important. Trial registration : This research was registered in the Clinical Trials Registry of Australia and New Zealand, with reference ACTRN12618001252202. [ABSTRACT FROM AUTHOR]

This study aimed to examine the effectiveness of social robots. When social robots are used by older adults with cognitive impairment, whether the care burden of family caregivers with cognitive impairment decreased, and if there is a change in personal and role strain. Methods: This study conducted a randomized controlled trial to examine the reduction in care burden (role strain, personal strain) of 27 family caregivers under the age of 60 after having older people with cognitive impairment use social robots at home for 6 weeks. For analysis, the Mann-Whitney U-test and Wilcoxon signed rank test were performed using SPSS version 26. Results: The pre-post survey result presented that care burden was not statistically significant but decreased in the experimental group (Z=-0.699, p=.485). Role strain, one of the sub-questions of care burden, presented a statistically significant reduction effect in the experimental group (Z=-2.031, p=.042). However, there was no statistically significant change in personal strain in both groups. Conclusion: The results of this study suggest the necessity of providing information reflecting the needs of family caregivers using social robots. In addition, the results present a way to respond to emergencies utilizing social robots’ monitoring functions and reduce family caregivers’ care burdens by offering services such as counseling and self-help groups. Furthermore, related organizations must educate formal and informal care workers on social robots. [ABSTRACT FROM AUTHOR]

Aim and objective: Mental well-being is one of the most important aspects of health. Life-threatening situations such as diseases affect mental well-being. Mindfulness-based stress reduction (MBSR) program is an effective program for improving well-being. This study aimed to evaluate the effectiveness of MBSR programs on the mental well-being of patients with coronavirus disease-2019 (COVID-19). Materials and methods: This randomized controlled trial study was conducted in 2021. We used simple random sampling for recruiting 60 patients with COVID-19 and assigned them to the intervention and control groups. The intervention comprised eight sessions of the MBSR and was performed for the experimental group. The control group received routine postdischarge care. We used a self-report demographic and Ryff's Psychological Well-being Scale to collect data. To analyze the data, descriptive statistics and inferential statistics including Covariance, MANCOVA, and effect coefficient were used. The Significance level was considered lower than 0. 05. We used SPSS version 21 for data management. Results: The mean score of mental well-being in the intervention group was 56.76 ± 6.88 in the pretest stage and 80.76 ± 7.53 in the posttest stage, and that in the control group was 54.40 ± 10.31 in the pretest stage and 51.23 ± 10.08 in the posttest stage. There was no significant difference between the two groups before the intervention (p >0.05) but there was a significant difference (p <0.05) after the intervention. There was also a significant difference (p <0.05) between the dimensions of mental well-being before and after the intervention. Conclusion: According to our findings, it is recommend to use MBSR program in line with physical treatment for patients with COVID-19. [ABSTRACT FROM AUTHOR]

This study showed that job crafting and work performance could be efficiently improved by the job crafting intervention program composed of task, relational, and cognitive crafting among younger workers. The current job crafting intervention program could be used as a new strategy to increase work performance of younger workers. Objective: This study reports a randomized controlled trial of the effect of a job crafting intervention program on work performance and job crafting (as secondary outcomes) among Japanese employees. Methods: Participants who satisfied the inclusion criteria were randomly allocated to an intervention (n  = 138) or a control group (n  = 143). Outcomes were measured at baseline and at 3-month and 6-month follow-up in both groups. Results: For the whole sample, the job crafting intervention program showed a nonsignificant effect on work performance and job crafting. However, the program showed a significant effect on these outcomes among younger participants (under 36years old). Conclusions: The job crafting intervention program may not be sufficiently effective to improve work performance and job crafting for the whole sample of participants. However, it may be efficacious for younger workers. [ABSTRACT FROM AUTHOR]

Background: Women with uterine fibroids often seek uterine-preserving treatments, rather than hysterectomy. Imaging-defined endpoints following nonsurgical treatments for fibroids are limited. Materials and Methods: Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), a randomized controlled trial of uterine artery embolization (UAE) versus magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS), enrolled premenopausal women with symptomatic uterine fibroids. In this subanalysis, we report imaging results up to 36 months after UAE or MRgFUS. Magnetic resonance imaging (MRI) was performed at baseline for all women and during the 36 months after treatment if they did not meet other study endpoints. The main outcome of this subanalysis was fibroid volume reduction (defined both in terms of total fibroid load and volume of the largest fibroid), uterine volume reduction, and nonperfused volume. Results: During 2010–2014, 25 of the 37 women who were randomized and treated at Mayo Clinic had a 24-month follow-up MRI (11 UAE; 14 MRgFUS); among these women, 15 (7 UAE and 8 MRgFUS) had a 36-month follow-up MRI. Average age for the cohort was 44.1 (standard deviation, SD = 4.4) years. Nine patients had a second fibroid procedure by 36 months (seven in the MRgFUS arm and two in UAE arm). Median total fibroid load reduction was ∼50% in both treatment arms at both 24- and 36-month follow-up. Volume of the largest fibroid decreased more in the MRgFUS arm, whereas uterine volume decreased more in the UAE arm (neither reached statistical significance). At 24 months, median nonperfused volume was higher in the UAE arm (92%) than the MRgFUS arm (10%). Conclusions: Similar fibroid volume reduction was seen for the MRgFUS and UAE treatments in this comparative effectiveness study. Nonperfused volume 24 months after the procedure was higher in the UAE arm than in the MRgFUS arm. Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov [ABSTRACT FROM AUTHOR]

Background: Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of nonexpanded adipose-derived mesenchymal stem cells. Autologous microfragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of rerupture and represent an ideal target for nonexpanded mesenchymal stem cells. Purpose: To evaluate the safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Consecutive patients referring to the investigation center for surgical treatment of magnetic resonance imaging–confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility. Those who were included were randomized to receive a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group) or not (control group). Clinical follow-up was conducted at 3, 6, 12, 18, and 24 months; at 18 months after surgery, magnetic resonance imaging of the operated shoulder was obtained to assess tendon integrity and rerupture rate. Results: An overall 177 patients were screened, and 44 (22 per group) completed the 24-month follow-up. A statistically significant difference in favor of the treatment group in terms of Constant-Murley score emerged at the primary endpoint at 6-month follow-up (mean ± SD; control group, 76.66 ± 10.77 points; treatment group, 82.78 ± 7.00 points; P =.0050). No significant differences in clinical outcome measures were encountered at any of the other follow-up points. No significant differences emerged between the groups in terms of rerupture rate, complication rate, and number of adverse events. Conclusion: This prospective randomized controlled trial demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair. Registration: NCT02783352 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Purpose: Lutetium-177 prostate-specific membrane antigen-617 (177Lu-PSMA-617) in end-stage metastatic castration-resistant prostate cancer (mCRPC) has reported favourable outcomes. In this study, we aimed to prospectively compare the efficacy and safety of 177Lu-PSMA-617 and docetaxel in chemotherapy-naïve mCRPC patients. Methods: This was a randomized, parallel-group, open-label, phase 2, and non-inferiority trial. Chemotherapy-naïve patients with mCRPC and high PSMA-expressing lesions on 68 Ga-PSMA-11 PET/CT were randomly assigned in 1:1 ratio to 177Lu-PSMA-617 (6.0–7.4 GBq/cycle, every 8 weeks, up to 4 cycles) or docetaxel (75 mg/m2/cycle, every 3 weeks, up to 10 cycles). The primary end-point was best prostate-specific antigen response rate (PSA-RR), defined according to Prostate Cancer Clinical Trials Working Group-3 as proportion of patients achieving ≥ 50% decline in PSA from baseline. Non-inferiority margin of − 15% was pre-specified for PSA-RR. Results: Between December 2019 and March 2021, 40 of the 45 patients assessed for eligibility underwent randomization. Fifteen of 20 patients in 177Lu-PSMA-617 arm and 20/20 patients in docetaxel arm received treatment per protocol. Of these, best PSA-RR in the 177Lu-PSMA-617 arm was 60% (9/15) versus 40% (8/20) in the docetaxel arm. The difference in the PSA-RRs between the two arms was 20% (95% confidence interval, CI: − 12–47, P = 0.25), meeting the pre-specified criterion for non-inferiority in per-protocol analysis. Further, progression-free survival rates at 6 months were 30% and 20% in the 177Lu-PSMA-617 and docetaxel arms respectively (difference 10%, 95% CI: − 18–38, P = 0.50). Overall, treatment-emergent grade ≥ 3 adverse events occurred less frequently with 177Lu-PSMA-617 than with docetaxel (6/20, 30% versus 10/20, 50%, respectively, P = 0.20). Quality-of-life outcomes improved significantly in 177Lu-PSMA-617 arm compared to docetaxel arm (P < 0.01). Conclusion: 177Lu-PSMA-617 was demonstrated to be safe and non-inferior to docetaxel in the treatment of mCRPC and could, thus, be potentially employed earlier in the disease course rather than being solely reserved for advanced end-stage disease. Clinical trial registration: Clinical Trials Registry-India, CTRI/2019/12/022282. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. Design: Randomized, controlled, parallel, double-blinded, three-arm clinical trial. Setting: Patients' homes through telerehabilitation devices. Subjects: Subjects with coronavirus disease 2019 in the acute phase. Interventions: Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. Main measures: We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. Results: From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre–post intervention score: strength exercises group: 7.85 [6.82] – 4.54[4.82], breathing exercises group: 11.04 [6.49] – 5.32 [3.63], control group: 10.27 [6.49] – 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre–post intervention score: strength exercises group: 12.19 [4.42] – 13.58 [5.37], breathing exercises group: 11.18 [3.42] – 12.79 [4.00], control group: 10.45 [2.15] – 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R 2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R 2 = 0.475). Conclusions: Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group. [ABSTRACT FROM AUTHOR]

Objectives: To compare a designated shared oral care intervention in a group of public nursing home residents with a standard oral care programme, focusing on levels of oral plaque and oral inflammation. Methods: A cluster randomized field trial was undertaken in 14 Danish public nursing homes. There were 145 participants included in the intervention group and 98 in the control group. We undertook a six‐month intervention based on the principle of situated interprofessional learning. The primary outcomes were plaque and inflammation levels measured with the mucosal plaque index (MPS); this was assessed at baseline, after three and six months (end of intervention), and at follow‐up (six months postintervention). The odds ratios (OR) and 95% confidence intervals (CI) were estimated with ordinal regression. Results: Socio‐demographic characteristics and oral health status at baseline were comparable between the two groups, with the exception of age: the intervention group were significantly younger than controls (median 82 vs 87 years). After three and six months, those receiving the shared oral care intervention had significantly lower plaque and inflammation than the control group. The adjusted ORs for a reduction in MPS were 11.8 (CI: 6.5‐21.3) and 11.0 (CI: 5.8‐20.9), respectively. At follow‐up, plaque levels and oral inflammation had approached the pre‐intervention level, with no remaining statistically significant group differences. Conclusions: The shared oral care intervention based on a situated learning perspective was effective in improving oral health among care home residents. However, after termination of the intervention, the effect quickly decreased. This confirms the challenges of achieving long‐term improvement in oral health in nursing home residents. An implementation strategy focusing on achieving changes at both organizational and individual levels with persistent attention to oral health care seem required for long‐term improvement. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to investigate the effect of salat activity on knee pain, muscle strength and range of motion after posterior stabilized total knee arthroplasty. Material-Method: This prospective randomized study was conducted in KTO Karatay University and Medova Hospital, Konya, Türkiye, between March 2019 and June 2019. Thirty volunteers between the ages of 55 and 75 who had undergone total knee arthroplasty participated in this study. Participants were randomly divided into two groups as Physical therapy group and Physical therapy + salat group. The participants in the physical therapy group were provided hot-cold application, transcutenous electrical nerve stimulation (TENS), active-assisted range of motion, stretching and strengthening exercises during four weeks. Physical therapy+salat group performed salat activity in addition to the treatment. The knee joint patency was measured using a digital goniometer, muscle strength using a manual muscle tester, knee pain with the visual analogue scale (VAS). Results: There was no difference in knee flexion and extension muscle strength between the groups before and after treatment (p = 0.05). There was no difference in VAS values between the groups before and after treatment (p = 0.05). Knee flexion angle increased significantly in the physical therapy+prayer group compared to the post-treatment physical therapy group (p=0.003). There was no significant difference between the groups in knee extension angle before and after treatment (p=0.05). Conclusion: In this study, it was found that Salat activity after knee arthroplasty improved knee joint range of motion. [ABSTRACT FROM AUTHOR]

Background Consumption of sugar-sweetened beverages, including fruit drinks (i.e. fruit-flavored drinks containing added sugar), contributes to childhood obesity. Objectives We aimed to examine whether nutrition-related claims on fruit drinks influence purchasing among parents and lead to misperceptions of healthfulness. Methods We conducted an experiment in a virtual convenience store with 2219 parents of children ages 1–5 y. Parents were randomly assigned to view fruit drinks displaying 1 of 3 claims ("No artificial sweeteners," "100% Vitamin C," and "100% All Natural") or no claim (i.e. control group). Parents selected among each of 2 drinks for their young child: 1) a fruit drink or 100% juice (primary outcome), and 2) a fruit drink or water. Results When choosing between a fruit drink and 100% juice, 45% of parents who viewed the fruit drink with the "No artificial sweeteners" claim, 51% who viewed the "100% Vitamin C" claim, and 54% who viewed the "100% All Natural" claim selected the fruit drink, compared with 32% in the no-claim control group (all P  < 0.001). "No artificial sweeteners" (Cohen's d  = 0.13, P  < 0.05) and "100% All Natural" (d  = 0.15, P  < 0.05) claims increased the likelihood of parents choosing the fruit drink instead of water but "100% Vitamin C" did not (P  = 0.06). All claims made parents more likely to incorrectly believe that the fruit drinks contained no added sugar and were 100% juice than the control (d ranged from 0.26 to 0.84, all P  < 0.001), as assessed in a posttest survey. The impact of claims on selection of the fruit drink (compared with 100% juice) did not vary by any of the moderators examined (e.g. race/ethnicity, income; all moderation P  > 0.05). Conclusions Nutrition-related claims led parents to choose less healthy beverages for their children and misled them about the healthfulness of fruit drinks. Labeling regulations could mitigate misleading marketing of fruit drinks. This trial was registered at clinicaltrials.gov as NCT04381481. [ABSTRACT FROM AUTHOR]

Background: Chronic Achilles and patellar tendinopathy are a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth, and facilitate rehabilitation. Purpose: To investigate the efficacy of HVIGI with and without steroid relative to placebo. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 62 participants were recruited between May 25, 2016, and March 5, 2020. Participants were men aged 18 to 55 years with Achilles or patellar tendinopathy of at least 6-month chronicity that had not improved with nonoperative management (including physical therapy and shockwave therapy), with ultrasound evidence of neovascularization, tendon thickening, and echogenic changes. They were assigned to the following groups: control (3 mL of subcutaneous 0.5% bupivacaine), HVIGI (10 mL of 0.5% bupivacaine and 30 mL of normal saline, ultrasound-guided between tendon and underlying fat pad), or HVIGI with steroid (HVIGIwSteroid; 0.25 mL of 100 mg/mL hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading program for 6 months postinjection. The main outcome measures were the Victoria Institute of Sport Assessments (VISA) for Achilles and patellar tendinopathy and the visual analog scale (VAS) for pain at 6 months postinjection. Results: The VISA score improved by a mean of 22.8 points (95% CI, 10.4-35.3 points; effect size [ES], 1.51) in the control group (n = 21), 18.6 points (95% CI, 9.1-28.0 points; ES, 1.31) in the HVIGI group (n = 21), and 18.5 points (95% CI, 3.4-33.6 points; ES, 0.88) in the HVIGIwSteroid group (n = 20). VAS pain improved by a mean of 15 points (interquartile range [IQR], -38.75, 8 points; ES, 0.39) in controls, 13 points (IQR,-34.0, 3.75 points; ES, 0.47) in the HVIGI group, and 27 points (IQR,-38.0, -1.0 points; ES, 0.54) in the HVIGIwSteroid group. The main effects were significant for time (P < .001) but not group (P ≥ .48), with no group x time interaction (P = .71). One participant was lost to follow-up from each group, multiple imputation was used for missing data points. No adverse events occurred. Conclusion: Study findings did not demonstrate superiority of HVIGI over control injection. [ABSTRACT FROM AUTHOR]

Chinese herbal medicine is increasingly used as complementary therapy to manage nausea and vomiting in different cultures. One such herbal recipe is the Hezhong granules, which contain classical antiemetic formulations, and are commonly used to prevent chemotherapy-induced nausea and vomiting (CINV). Modern pharmacological studies have shown that the key components of Hezhong granules, including Pinellia ternata (Thunb.), Evodia rutaecarpa (Juss.), and Zingiber officinale exhibit significant antiemetic and antitumor properties. Despite this promising evidence, controlling CINV remains a significant challenge in cancer treatment. Moreover, there is a lack of scientifically designed clinical trials to validate the efficacy and safety of classical antiemetic formulas for CINV interventions. To investigate the efficacy and safety of Hezhong granules in preventing CINV in patients with advanced colorectal cancer (CRC). This study was conducted between October 2020 and February 2022 in 12 hospital wards in Southwest China. In this multicenter, randomized controlled trial, we enrolled patients with advanced CRC who received fluorouracil-based chemotherapy. The patients were randomly assigned in a 1:1 ratio to either the Hezhong granule group (receiving a 5-HT3-receptor antagonist, dexamethasone, and Hezhong granules) or the placebo group (receiving a 5-HT3-receptor antagonist, dexamethasone, and placebo) during the first and second courses of chemotherapy. A 5-day diary was provided to all patients. Acute and delayed CINV were defined as CINV occurring within 24 h or between 24 and 120 h after the start of treatment. The primary endpoints were complete response rate (CRR, defined as the proportion of patients without nausea/vomiting) and objective response rate (ORR, defined as the proportion of patients without nausea/vomiting plus mild nausea/vomiting) for both acute and delayed CINV. Secondary endpoints were the daily rates of CINV events and Functional Living Index-Emesis (FLIE). To identify the predictors of CINV, we conducted multivariate ordered logistic regression analysis. This study was registered with the Chinese Clinical Trial, number ChiCTR2100041643. A total of 120 participants were randomly assigned, of whom 112 (56/56) completed two cycles and were included in the full analysis. In the acute phase, there were minor improvements in the Hezhong granule group, but there were no significant differences in the CRRs for nausea and vomiting (mean difference:10.7 %, P = 0.318, 0.324), while the ORRs increased by approximately 17.5 % (mean difference:16.1 %, P = 0.051; 17.9 %, P = 0.037, respectively). In the delayed phase, significant improvements of approximately 20 % were observed in both the CRRs (mean difference:19.6 %, P = 0.053; 21.4 %, P = 0.035) and ORRs (mean difference:17.9 %, P = 0.037, 0.043) for nausea and vomiting. Additionally, the daily rate of CINV events showed a mean difference of 19 % (P < 0.05). According to FLIE scores, approximately 70 % of patients who received Hezhong granules reported an improvement in their quality of life, with CINV symptoms having"no impact on daily life (NIDL)". No serious adverse events were attributed to herbal medicine. Hezhong granules proved to be both effective and well-tolerated in preventing CINV in patients with advanced CRC, with notable benefits in preventing delayed CINV. These promising results set the stage for subsequent phase III clinical trials and experimental research on Hezhong Granules. [Display omitted] • Hezhong granule can increase the complete response rate of CINV by about 10 %–20 %. • Hezhong granule can increase the objective response rate of CINV by about 16 %–18 %. • Hezhong granule show better efficacy in preventing delayed CINV. • Hezhong granule is well tolerated and can significantly improve the quality of life of patients. [ABSTRACT FROM AUTHOR]

People engaged in treatment for opioid use disorder (OUD) report struggling with whether and how to disclose, or share information about their OUD history and/or treatment with others. Yet, disclosure can act as a gateway to re-establishing social connection and support during recovery. The current study describes a pilot randomized controlled trial of Disclosing Recovery: A Decision Aid and Toolkit, a patient decision aid designed to facilitate disclosure decisions and build disclosure skills. Participants (n = 50) were recruited from a community-based behavioral health organization in 2021–2022 and randomized to receive the Disclosing Recovery intervention versus an attention-control comparator. They responded to surveys immediately after receiving the intervention as well as one month following the intervention at a follow-up appointment. Primary outcome analyses examined indicators of implementation of the intervention to inform a future efficacy trial. Secondary outcome analyses explored impacts of the intervention on the decision-making process, disclosure rates, and relationships. Participants were successfully recruited, randomized, and retained, increasing confidence in the feasibility of future efficacy trials to test the Disclosing Recovery intervention. Moreover, participants in the Disclosing Recovery intervention agreed that the intervention is acceptable, feasible, and appropriate. They additionally reported a higher quality of their decision-making process and decisions than participants in the comparator condition. At their follow-up appointment, participants with illicit opioid use who received the Disclosing Recovery intervention were less likely to disclose than those who received the comparator condition. Moreover, significant interactions between illicit opioid use and the intervention condition indicated that participants without illicit opioid use who received the Disclosing Recovery intervention reported greater closeness to and social support from their planned disclosure recipient than those who received the comparator condition. The Disclosing Recovery intervention appears to be an acceptable, feasible, and appropriate patient decision aid for addressing disclosure processes among people in treatment for OUD. Moreover, preliminary results suggest that it shows promise in improving relationship closeness and social support in patients without illicit opioid use. More testing is merited to determine the intervention's efficacy and effectiveness in improving relationship and treatment outcomes for people in treatment for OUD. • People in opioid use disorder (OUD) treatment struggle with disclosure decisions. • Disclosing Recovery is a patient decision aid for disclosure decisions and skills. • It appears to be acceptable, appropriate, and feasible. • Future trials should examine its impacts on relationship and treatment outcomes. [ABSTRACT FROM AUTHOR]