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Objective: To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. Methods: A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. Results: The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3–0.9, P<0.001) TST and 34.1% (10.3%–58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed −3.3 (−3.8 to −2.7) in the CM group, a −2.0 (−3.2 to −0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased −2.0 (−3.3 to −0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. Conclusion: CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183). [ABSTRACT FROM AUTHOR]

Background: Standardization of health systems often hinders client‐centered care. This study investigates whether allowing more flexibility in the planning range of the Dutch home‐based postpartum care service improves its quality of care, as innovative approach to client‐centered care. Methods: A randomized controlled trial was conducted (2017–2019), in which pregnant women who intended to breastfeed were assigned into two groups (1:1). The intervention group was allowed to receive care up to the 14th‐day postpartum, instead of the first 8–10 consecutive days ("usual care"). Primary outcome measure was the proportion of newborns still receiving exclusively breastmilk on final caring day of the service. This so‐called successful breastfeeding rate is currently used by the Dutch health sector to measure the quality of care. Secondary outcome measures were self‐care experience, overall care experience, and exclusive breastfeeding duration rate. Results: Based on data from 1275 participants, there was no difference in exclusive breastfeeding on final caring day (86,7% intervention group vs. 88,9% control group, RR: 1.03, 95% CI: 0.98–1.07). Both groups showed similar self‐care experiences. Women in the intervention group had slightly poorer overall care experience and lower exclusive breastfeeding duration rates. Conclusions: This study found no effect on the quality of care when allowing more flexibility in the planning range of home‐based postpartum care. Women can, therefore, be offered more flexibility to suit them. Given the confusion in interpreting the sector's current main quality indicator, we call for an inclusive dialogue on how to best measure the quality of home‐based postpartum care. [ABSTRACT FROM AUTHOR]

Background: In an Australian randomized controlled trial (RCT), two techniques for intrapartum fetal surveillance were compared: ST analysis (STan) as an adjunct to cardiotocography (CTG), compared with CTG alone. The aim was to determine whether CTG + STan could reduce emergency cesarean birth rates while maintaining or improving neonatal outcomes. Secondary aims were to compare clinical, economic, and psychosocial outcomes. The purpose of this paper was to present psychosocial outcomes from one cohort enrolled in the trial. Methods: The study was conducted at one tertiary referral hospital. Participants who had taken part in the trial from the outset were invited to complete a questionnaire between March 2018 and January 2020, approximately 8 weeks after giving birth. Outcomes included depression, psychological distress, health‐related quality of life, and infant feeding practices. Analysis was by intention to treat. Results: N = 207/527 participants completed the questionnaire (n = 113, STan; n = 94, CTG alone). Overall, no statistically significant or clinically meaningful differences were found in the two groups for symptoms of depression, psychological distress, quality of life, or infant feeding. A statistically significant difference was observed for the subscale of pain‐discomfort, where scores were higher on average in the CTG alone arm relative to that in the CTG + STan arm. Conclusions: Although STan as an adjunct to CTG constitutes a different clinical technology from CTG alone, both monitoring types appeared to produce similar results in terms of postnatal psychosocial outcomes for women. Findings from this study provide service users and staff with a comprehensive assessment of STan that can be used to make evidence‐informed decisions about monitoring options should STan become more widely available. [ABSTRACT FROM AUTHOR]

Background: Obsessive-compulsive disorder (OCD) is a prevalent and burdensome mental health condition, often resistant to conventional treatments. Agomelatine (Valdoxan), a compound acting on serotonin and melatonin systems, has shown promise in treating those with treatment-resistant OCD based on anecdotal reports and case studies. Methods: A randomized, double-blind controlled trial was conducted with 60 patients diagnosed with treatment-resistant OCD. Participants were randomized into an intervention group (receiving agomelatine 50 mg/day) and a control group (receiving placebo). OCD symptoms were assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) over a 12-week period. Results: There were no significant differences in age, gender, or baseline Y-BOCS scores between intervention and control groups. Agomelatine did not demonstrate a significant improvement in OCD symptoms compared to placebo. Adverse events were comparable between groups, and liver enzyme levels remained within the normal range. Conclusion: This study, while not confirming superior efficacy compared to placebo, underscores the need for continued investigation into agomelatine's potential for treating specific subgroups of OCD patients, underscoring the need for more comprehensive and well-controlled trials in the future. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China. Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group (241 cases) and placebo group (82 cases) by stratified block randomization. Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day, orally, respectively since the first day of menstruation for 3 consecutive menstrual cycles. The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months. The secondary endpoint was the pain score evaluated by VAS (chronic pelvic pain, defecation pain, and dyspareunia) at 3 and 6 months, and the pain recurrence rate at 6 months. Adverse events (AEs) were recorded during the study. Results: A total of 241 women were included in the SAC group, and 82 were in the placebo group. Among these women, 217 (90.0%) and 71 (86.6%) completed the intervention, respectively. At 3 months, overall response rate (ORR) was significantly higher in women administered SAC (80.1%) compared with those who received a placebo (30.5%, P<0.01). Six months after treatment, the ORR for dysmenorrhea was 62.7% in the SAC group and 31.7% in the placebo group (P<0.01). Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo (both P<0.05). The incidence rates of total AEs events in the SAC and placebo groups were 6.6% and 9.8%, respectively, and no significant difference was shown between the two groups (P=0.339). Conclusion: SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523) [ABSTRACT FROM AUTHOR]

Objective: To confirm the efficacy and safety of Ganyushu Granule (GYSG) in treating premenstrual syndrome (PMS) in patients with Gan (Liver) depression and qi stagnation syndrome (GDQSS) and determine its effective dosage. Methods: From June 2018 to March 2021, a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1:1:1 ratio using central block randomization: high-dose GYSG group (n=78, GYSG 2 packs/time), low-dose GYSG group (n=82, GYSG and its simulant 1 pack/time), and placebo group (n=80, GYSG simulant 2 packs/time). Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles. Primary outcomes were PMS diary (PMSD) score and premenstrual tension syndrome self-rating scale (PMTS). Secondary outcomes were Chinese medicine (CM) syndrome efficacy. PMSD, PMTS, and efficacy of CM were evaluated with menstrual cycles during the treatment period. Outcome indicators were analyzed after each menstrual cycle. All analyses were performed using an intention-to-treat method, and clinical safety was assessed. Results: Of the 216 patients included in the effectiveness analysis, 70, 75, and 71 patients were in the high-, low-dose GYSG, and placebo groups, respectively. From the 2nd treatment cycle, the change in PMSD scores in the high- and low-dose groups was lower than that in the placebo group (P<0.05). PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group (P<0.05), while after the 3rd treatment cycle, that in the low-dose group was lower than that in the placebo group (P<0.05). After the 2nd treatment cycle, the high-dose GYSG group had the best CM syndrome efficacy (P<0.05). No serious adverse reactions were reported. Conclusions: GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS. High-dose GYSG might be the optimal dose for a phase III trial. (Registration No. ChiCTR1800016595) [ABSTRACT FROM AUTHOR]

Background: Laser acupuncture is a proven non-invasive treatment with effects comparable to traditional acupuncture in different types of headaches, but there is still insufficient evidence for chronic migraine (CM) in adults. We aim to investigate the efficacy and safety of laser acupuncture (LA) as an add-on preventive therapy on CM. Methods: A single-blind randomized controlled trial was conducted from January 2022 to November 2023. CM patients with unsatisfactory pharmacological effects were randomly assigned in a 1:1 ratio to receive either LA or sham treatment over a course of 8 sessions spanning 4 weeks. The co-primary outcomes were changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline. Evaluations were taken at baseline (12 weeks before randomization), at 4th week (treatment completed), 8th week and 12th week from baseline. Results: A total of 60 patients (30 in each group) were included in the intention-to-treat analyses. Baseline headache characteristics between trial groups were similar. Compared with the sham group, the LA group had a significant reduction in MMD (5.2 vs. 1.5 days at 8th week, p = 0.015; 7.3 vs. 1.8 days at 12th week, p = 0.001), and acute headache medications usage days per month (3.1 vs. 0.4 days at 4th week, p = 0.007; 3.2 vs. 0.0 days at 8th week, p = 0.005; 3.9 vs. 0.0 days at 12th week, p < 0.001). No serious adverse event was observed in both groups. Conclusions: Laser acupuncture was effective in reducing MMD and acute headache medications usage with promising safety. Specifically, the efficacy of LA exhibited a progressively more pronounced effect within the follow-up period. We suggested that LA is a promising add-on preventive therapy for CM, and trials focused on investigating the mechanism of LA's effect and its long-term effects on CM prevention are justified. Trial registration: The study was retrospectively registered at ISRCTN.org Identifier: ISRCTN11208146 (https://doi.org/10.1186/ISRCTN11208146). The registration date: 19, January, 2024. The date of first participant registration: 04, May, 2022. [ABSTRACT FROM AUTHOR]

Background: The current clinical management of carotid atherosclerosis is based on the control of risk factors and medicine. However, the risk of adverse events associated with the medicine resulting in concerns and low medication compliance makes it necessary to seek a safer alternative therapy. This study assessed the effectiveness and safety of acupuncture as a treatment for carotid atherosclerosis. Methods: In this randomized controlled trial, patients with carotid atherosclerotic plaques were included and randomly assigned (1:1) to receive real acupuncture or sham acupuncture for 12 weeks. The follow-up period was 12 weeks. The primary outcome included carotid intima-media thickness (cIMT), plaque score (PS), plaque volume (PV) and grey-scale median (GSM). Secondary outcome was pulse wave velocity (PWV). Adverse events results were recorded as safety outcomes. Results: From January 2021 to February 2022, 60 eligible patients were included. 55 patients (91.7%) completed the intervention and the 12-week follow-up and there was no statistical difference in demographics between the groups. At the end of treatment, the real acupuncture group had significantly reduced PS (P = 0.002), PV (P = 0.000), and improved GSM (P = 0.044). There was no significant difference in the reduction in cIMT (Left cIMT: P = 0.338, Right cIMT: P = 0.204) and PWV between the groups (the left BS: P = 0.429; the left ES: P = 0.701; the right BS: P = 0.211; the right ES: P = 0.083). Three mild adverse reactions occurred during the study. Conclusion: This study found that acupuncture had a certain effect on reducing the thickness and volume of carotid plaque and improving the stability of plaque with minor side effects. These findings suggest that acupuncture may be a potential alternative therapy for carotid atherosclerosis. Trial registration: This trial has been registered at ClinicalTrials.gov (ChiCTR2100041762). Submitted 30 December 2020, Registered 4 January 2021 Prospectively registered. [ABSTRACT FROM AUTHOR]

Background: Preterm infants are at high risk for retinopathy of prematurity (ROP), with potential life-long visual impairment. Low fetal hemoglobin (HbF) levels predict ROP. It is unknown if preventing the HbF decrease also reduces ROP. Methods: BORN is an ongoing multicenter double-blinded randomized controlled trial investigating whether transfusing HbF-enriched cord blood-red blood cells (CB-RBCs) instead of adult donor-RBC units (A-RBCs) reduces the incidence of severe ROP (NCT05100212). Neonates born between 24 and 27 + 6 weeks of gestation are enrolled and randomized 1:1 to receive adult donor-RBCs (A-RBCs, arm A) or allogeneic CB-RBCs (arm B) from birth to the postmenstrual age (PMA) of 31 + 6 weeks. Primary outcome is the rate of severe ROP at 40 weeks of PMA or discharge, with a sample size of 146 patients. A prespecified interim analysis was scheduled after the first 58 patients were enrolled, with the main purpose to evaluate the safety of CB-RBC transfusions. Results: Results in the intention-to-treat and per-protocol analysis are reported. Twenty-eight patients were in arm A and 30 in arm B. Overall, 104 A-RBC units and 49 CB-RBC units were transfused, with a high rate of protocol deviations. A total of 336 adverse events were recorded, with similar incidence and severity in the two arms. By per-protocol analysis, patients receiving A-RBCs or both RBC types experienced more adverse events than non-transfused patients or those transfused exclusively with CB-RBCs, and suffered from more severe forms of bradycardia, pulmonary hypertension, and hemodynamically significant patent ductus arteriosus. Serum potassium, lactate, and pH were similar after CB-RBCs or A-RBCs. Fourteen patients died and 44 were evaluated for ROP. Ten of them developed severe ROP, with no differences between arms. At per-protocol analysis each A-RBC transfusion carried a relative risk for severe ROP of 1.66 (95% CI 1.06–2.20) in comparison with CB-RBCs. The area under the curve of HbF suggested that HbF decrement before 30 weeks PMA is critical for severe ROP development. Subsequent CB-RBC transfusions do not lessen the ROP risk. Conclusions: The interim analysis shows that CB-RBC transfusion strategy in preterm neonates is safe and, if early adopted, might protect them from severe ROP. Trial registration: Prospectively registered at ClinicalTrials.gov on October 29, 2021. Identifier number NCT05100212. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I–III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary—the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary—the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann–Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I–III. The findings are promising, but need to be substantiated by further phase 3 trials. Clinical Trial Registration Number: CTRI/2020/03/024342. [ABSTRACT FROM AUTHOR]

Background: Rural family caregivers (FCGs) in the United States often experience high economic costs. This randomized controlled trial compared a transitional palliative care intervention (TPC) to support FCGs of seriously ill care recipients (CRs) to an attention control condition. We evaluated the TPC's effect on healthcare use and out‐of‐pocket spending for both FCGs and CRs. Methods: TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months or CR death to collect self‐reported healthcare utilization (e.g., outpatient, emergency department, and hospital), out‐of‐pocket healthcare spending (e.g., deductibles and coinsurance), and health‐related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRRs) were estimated using negative binomial regressions. Results: The study included 282 FCG–CR dyads across three U.S. states. Follow‐up over the 6‐month period was shortened by high CR mortality rates across both arms (29%), but was similar across arms. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% confidence interval [CI] = 0.56–0. 99). Total out‐of‐pocket spending was not significantly different for TPC versus control. Across both groups, mean out‐of‐pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56–0.89). Conclusions: This study contributes to evidence that palliative care interventions reduce the number of nights in the hospital for seriously ill patients. Yet, overall rural FCGs and seriously ill CRs experience substantial out‐of‐pocket economic costs in the 6 months following hospitalization. Transitional care intervention design should consider impacts on patient and caregiver spending. Clinicaltrials.gov # is NCT03339271. [ABSTRACT FROM AUTHOR]

Purpose: The manifestation of behavioral and psychological symptoms of dementia (BPSD) poses a considerable care burden and precipitates adverse health outcomes. Despite the increasing development of digital interventions, their application in the dementia population, specifically regarding their effectiveness in addressing BPSD, remains limited. Therefore, in this study, we aimed to describe a study protocol for evaluating the effectiveness of a mobile app-based individualized non-pharmacological intervention to improve BPSD in community-dwelling older adults. Methods: Employing a randomized control group pretest-posttest design, 36 dyads comprising people living with dementia (PLWD) and their family caregivers will be assigned to either an experimental or control group. The experimental group will engage in a 4-week regimen using a mobile app-based individualized non-pharmacological intervention, which includes recording and predicting BPSD. The control group will use the BPSD record system without accessing the individualized interventions. Both groups will continue with their usual care practices throughout the study period. Results: We hypothesize that the implementation of the mobile app-based individualized non-pharmacological intervention will alleviate BPSD. After the intervention, results will be analyzed to evaluate the effectiveness of the mobile app-based individualized non-pharmacological intervention on BPSD. Conclusion: The research team may encounter several challenges owing to the novelty of digitalized interventions. Nevertheless, the results of this study will provide robust evidence regarding the efficacy of mobile app-based individualized non-pharmacological interventions for community-dwelling older PLWD. [ABSTRACT FROM AUTHOR]

Objectives: This study was conducted in order to determine the effect on halitosis and the antibacterial effect against halitosis‐causing bacteria of the mouthwash made of the natural material, Glycyrrhiza uralensis (G. uralensis) extract. Materials and Methods: A randomized, double‐blind, placebo‐controlled study was conducted on 60 patients who visited M dental clinic located in Busan, South Korea, excluding those with systemic disease that may induce halitosis. There were 30 patients classified to the saline gargle group and the remaining 30 patients were classified to the G. uralensis extract gargle group. In addition, their level of halitosis and halitosis‐causing bacteria were measured. They visited the dental clinic on a fasted state at baseline before gargle application (Baseline), immediately after gargle application (Treatment) and 5 days after gargle application (After 5 Days). For clinical indicators, participants were tested for halitosis and bacteria immediately after waking up without brushing their teeth and without hydration. Results: The prevalence of halitosis decreased in the G. uralensis extract gargle group compared to the saline gargle group at Treatment and After 5 Days. In cases with pseudo halitosis, there was a significant decrease in halitosis‐causing bacteria when G. uralensis extract gargle was applied (p < 0.05). Conclusions: It was identified that using a mouthwash made with G. uralensis extract is effective for halitosis improvement and reduction of halitosis‐causing bacteria. Therefore, using a mouthwash containing G. uralensis extract, it will be effective in improving bad breath and oral hygiene will be possible. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether Naoxueshu Oral Liquid (NXS) could promote hematoma absorption in post-craniotomy hematoma (PCH) patients. Methods: This is an open-label, multicenter, and randomized controlled trial conducted at 9 hospitals in China. Patients aged 18–80 years with post-craniotomy supratentorial hematoma volume ranging from 10 to 30 mL or post-craniotomy infratentorial hematoma volume less than 10 mL, or intraventricular hemorrhage following cranial surgery were enrolled. They were randomly assigned at a 1:1 ratio to the NXS (10 mL thrice daily for 15 days) or control groups using a randomization code table. Standard medical care was administered in both groups. The primary outcome was the percentage reduction in hematoma volume from day 1 to day 15. The secondary outcomes included the percentage reduction in hematoma volume from day 1 to day 7, the absolute reduction in hematoma volume from day 1 to day 7 and 15, and the change in neurological function from day 1 to day 7 and 15. The safety was closely monitored throughout the study. Moreover, subgroup analysis was performed based on age, gender, history of diabetes, and etiology of intracerebral hemorrhage (ICH). Results: A total of 120 patients were enrolled and randomly assigned between March 30, 2018 and April 15, 2020. One patient was lost to follow-up in the control group. Finally, there were 119 patients (60 in the NXS group and 59 in the control group) included in the analysis. In the full analysis set (FAS) analysis, the NXS group had a greater percentage reduction in hematoma volume from day 1 to day 15 than the control group [median (Q1, Q3): 85% (71%, 97%) vs. 76% (53%, 93%), P<0.05]. The secondary outcomes showed no statistical significance between two groups, either in FAS or per-protocol set (P>0.05). Furthermore, no adverse events were reported during the study. In the FAS analysis, the NXS group exhibited a higher percentage reduction in hematoma volume on day 15 in the following subgroups: male patients, patients younger than 65 years, patients without diabetes, or those with initial cranial surgery due to ICH (all P<0.05). Conclusions: The administration of NXS demonstrated the potential to promote the percentage reduction in hematoma volume from day 1 to day 15. This intervention was found to be safe and feasible. The response to NXS may be influenced by patient characteristics. (Registration No. ChiCTR1800017981) [ABSTRACT FROM AUTHOR]

This study compares the clinical performances of two lithium disilicate (Initial LiSi press vs. Initial LiSi Block, GC Corp.) and a 3D printed resin (Temp Print, GC Corp.) partial crown using modified United States Public Health Service (USPHS) evaluation criteria and survival rates after one year of clinical service. Eighty-nine partial adhesive restorations on posterior teeth were realized using different materials: Group 1 used Initial LiSi press, Group 2 used Initial LiSi Block, and Group 3 used Temp Print. An analog workflow was used to realize the restoration of Group 1, while a fully digital workflow was used for Groups 2 and 3. The modified USPHS parameters, together with periodontal parameters, were collected at baseline and at the one-year recall. Contingency tables to assess for significant differences of success over time in each group were used. All modified USPHS parameters showed Alpha or Bravo; no Charlie was recorded. No statistically significant difference emerged between the three groups in any of the assessed variables (p > 0.05). All modified USPHS scores were compatible with the outcome of clinical success, no restoration was replaced or repaired, and the survival rate was 100% at the one-year recall. No difference was found between the traditional and digital workflows used to fabricate the restorations. [ABSTRACT FROM AUTHOR]

Background: Early childhood educators play a critical role in promoting physical activity and reducing sedentary time in childcare centres. However, early childhood educators receive limited specialised pre- and in-service learning opportunities relating to these behaviours and may lack the capacity to effectively engage children in healthy movement behaviours. This study aimed to examine the efficacy of an e-Learning course on increasing early childhood educators' physical activity and sedentary behaviour-related capacities. Methods: A two-group parallel randomized controlled trial was conducted with early childhood educators in Canada (Mage = 41.78, 97% female). Participants randomized to the intervention group were asked to complete a physical activity and sedentary behaviour e-Learning course within a 4-week period. Participants randomized to the waitlist control condition were assigned to a waitlist to receive the intervention after the testing period. Participants reported on their self-efficacy, knowledge, intentions, and perceived behavioural control relating to physical activity and sedentary behaviours at baseline, post-intervention, and 3 months follow-up. Linear mixed effects models were estimated to determine difference in changes in outcomes from baseline to post-intervention, and follow-up. Results: A total of 209 early childhood educators participated in the study (intervention n = 98; control n = 111). The TEACH e-Learning course was found to be efficacious at improving all of the examined outcomes, with standardized effect sizes ranging from d = 0.58 to d = 0.65 for self-efficacy outcomes, d = 0.66 to d = 1.20 for knowledge outcomes, d = 0.50 to d = 0.65 for intention outcomes, and d = 0.33 to d = 0.69 for perceived behavioural control outcomes post-intervention. The intervention effects were sustained at follow-up for all outcomes apart from perceived behavioural control to limit screen time. Additionally, the magnitude of the effect for knowledge outcomes decreased at follow-up, with standardized effect sizes ranging from d = 0.49 to d = 0.67. Conclusions: The e-Learning course was highly successful at improving early childhood educators' capacity pertaining to physical activity and sedentary behaviours. Providing training content through e-Learning may be an efficacious approach to providing continual professional learning opportunities relating to physical activity and sedentary time to early childhood educators on a large scale. [ABSTRACT FROM AUTHOR]

Objectives: Sciatica is a debilitating condition that causes pain in its distribution or in the lumbosacral nerve root that is connected to it. Although there are claims that homeopathy can reduce sciatica pain, systematic scientific proof is currently lacking. The objective of the trial was to determine whether individualized homeopathic medicines (IHMs) were as effective as identical-looking placebos in treating sciatica pain. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The study was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Sixty participants with sciatica pain were included in this study. Interventions: Verum (n = 30; IHMs plus concomitant care) versus control (n = 30; placebos plus concomitant care). Outcome measures: Primary—Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores and secondary—Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores: all of them were measured at baseline, and every month, up to 3 months. Results: Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily accounting for between groups and time interactions, and additionally, by unpaired t tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 and <0.05 two tailed for the primary and secondary outcomes, respectively. Group differences could not achieve significance in SBI (p = 0.044), SFI (p = 0.080), and RMPDQ scores (p = 0.134), but were significant for SF-MPQ (p = 0.007) and OLBPQ (p = 0.036). Gnaphalium polycephalum (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, or intercurrent illnesses were recorded in either of the groups. Conclusions: The primary outcome failed to demonstrate evidently that homeopathy was effective beyond placebo, and the trial remained inconclusive. Independent replications are warranted to confirm the findings. Clinical Trial Registration Number: CTRI/2020/10/028617. [ABSTRACT FROM AUTHOR]

Background and aims: Pre‐clinical studies suggest that the simultaneous blockade of the α1b and 5HT2A receptors may be effective in reducing alcohol consumption. This study aimed to assess the efficacy and safety of prazosin (α1b blocker) and cyproheptadine (5HT2A blocker) combination in decreasing total alcohol consumption (TAC) in alcohol use disorder (AUD). Design, setting and participants: This was a double‐blind, parallel group, placebo‐controlled, Phase 2, randomized clinical trial conducted in 32 addiction treatment centres in France. A total of 108 men and 46 women with severe AUD took part. Intervention: Participants were randomly assigned to one of the following 3‐month treatments: (1) low‐dose group (LDG) receiving 8 mg cyproheptadine and 5 mg prazosin extended‐release (ER) formulation daily; (2) high‐dose group (HDG) receiving 12 mg cyproheptadine and 10 mg prazosin ER daily; and (3) placebo group (PG) receiving placebo of cyproheptadine and prazosin ER. A total of 154 patients were randomized: 54 in the PG, 54 in the LDG and 46 in the HDG. Measurements The primary outcome was TAC change from baseline to month 3. Findings: A significant main treatment effect in the change in TAC was found in the intent‐to‐treat population (P = 0.039). The HDG and LDG showed a benefit in the change in TAC from baseline to month 3 compared with PG: −23.6 g/day, P = 0.016, Cohen's d = −0.44; −18.4 g/day, P = 0.048 (Bonferroni correction P < 0.025), Cohen's d = −0.36. In a subgroup of very high‐risk drinking‐level participants (> 100 g/day of pure alcohol for men and > 60 g/day for women), the difference between the HDG and the PG in the primary outcome was −29.8 g/day (P = 0.031, Cohen's d = −0.51). The high and low doses were well‐tolerated with a similar safety profile. Conclusions: A randomized controlled trial of treatment of severe alcohol use disorder with a cyproheptadine−prazosin combination for 3 months reduced drinking by more than 23 g per day compared with placebo. A higher dose combination was associated with a larger magnitude of drinking reduction than a lower dose combination while showing similar safety profile. [ABSTRACT FROM AUTHOR]

Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [ABSTRACT FROM AUTHOR]

Background: It is necessary to better understand the structural characteristics of the supraspinatus tendon and associated muscle after rotator cuff repair and in the event of retear. Purpose: To study structural differences between the repaired and contralateral shoulders 1 year after rotator cuff repair in patients who received either progressive exercise therapy (PR) or usual care (UC) in a randomized controlled trial and to investigate whether there was interaction with tendon retear and limb dominance. Study Design: Cohort study; Level of evidence, 2. Methods: Patients with surgically repaired traumatic full-thickness rotator cuff tears involving the supraspinatus tendon were included. After surgery, they were randomized to PR or UC (active from postoperative week 2 or 6, respectively). The subacromial structures (acromiohumeral distance, supraspinatus tendon thickness, and vascularity) and the supraspinatus muscle thickness were examined with ultrasound at the 1-year follow-up. Results: A total of 79 patients were included. The characteristics of the 2 intervention groups (PR and UC) were comparable, including the Western Ontario Rotator Cuff Index score and number of retears. The authors found significantly thinner supraspinatus tendon (PR, P <.001; UC, P =.003) and reduced acromiohumeral distance (PR, P =.023; UC, P =.025) in the repaired versus the contralateral shoulders in both intervention groups. For neovascularization, there was no interlimb difference in either of the groups or between groups (PR vs UC). In patients with intact tendons, there was no interlimb difference in the muscle thickness, but in patients with tendon retear the muscle was significantly thinner on the repaired side (P =.024 and P <.001, respectively). When the dominant supraspinatus tendon was repaired (both groups), it was significantly thinner than the nondominant healthy tendon, but this difference was not seen when the nondominant supraspinatus tendon was repaired (P =.006). Conclusion: One year after rotator cuff surgery, the repaired supraspinatus tendon was significantly thinner and the corresponding acromiohumeral distance was reduced. In patients with retear, the supraspinatus muscle was significantly thinner on the repaired side and early initiation of tendon-loading exercises did not affect these findings. Registration: NCT02969135 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients. In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales. The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals' SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group's outcomes at each assessment point. Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals' sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Background: This randomized controlled trial aimed to compare the effects of butorphanol and sufentanil on early post-operative cognitive dysfunction (POCD) and systemic inflammation in older surgical patients. Methods: Patients (aged 65  years or above) undergoing surgeries with general anesthesia were randomized to either the butorphanol group (40  μg/kg during anesthesia induction) or the sufentanil group (0.4  μg/kg). Cognitive function changes during the perioperative period were assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) scale up to 3  days after surgery. POCD was defined as a Z-score or composite Z-score greater than 1.96 for both MMSE and MoCA scores. Circulating inflammatory factors, including tumor necrosis factor-alpha (TNF-α), interleukin 1 beta (IL-1β), and interleukin 10 (IL-10), were measured using enzyme-linked immunosorbent assay. Results: The study included 114 patients (median age: 71  years, 57.7% male). Compared to sufentanil, butorphanol significantly reduced the incidence of POCD on the first (11.5% versus 32.7%, p  =  0.017) and third day (3.8% versus 15.4%, p  =  0.046) after surgery. Additionally, patients receiving butorphanol had significantly lower circulating levels of TNF-α and IL-1β at the time of discharge from the post-anesthesia care unit and on the first and third day after surgery (p  <  0.05 for all comparisons). Furthermore, circulating IL-10 levels were significantly higher in patients receiving butorphanol (p  <  0.05 for all comparisons). Conclusion: Administration of butorphanol during anesthesia induction, as opposed to sufentanil, was associated with a significant reduction in the early incidence of POCD in older surgical patients, possibly attributed to its impact on systemic inflammation. [ABSTRACT FROM AUTHOR]

Background: Veterans have a high prevalence of opioid prescriptions to manage chronic low back pain (CLBP), resulting in increased risk of becoming addicted and overdosing. It is important to identify effective and safe mind–body interventions to reduce opioid use for veterans with CLBP. Qigong, a mind–body therapy, is a promising approach to manage CLBP in veterans. This study assessed the feasibility and acceptability of qigong and examined whether pain is reduced after a qigong intervention. Methods: In this randomized controlled trial, 31 participants were randomized to the qigong intervention (n = 15) or a wait-list control group (WLCG; n = 16). The qigong intervention was conducted twice weekly in 45-minute sessions for 8 weeks (total of 16 sessions). Participants who completed the qigong intervention were invited to participate in a focus group conducted through videoconferencing. In addition to assessing feasibility and acceptability of the qigong intervention, pain intensity, pain interference, and low back pain and disability were measured at baseline and postintervention. Results: Qigong is a feasible intervention for veterans with CLBP, based on retention (83%), attendance (70%), and fidelity (100%), with no injury or other adverse events. Qigong was acceptable to the veterans with CLBP, who reported that they would continue to practice qigong to manage CLBP for long-term effects. Statistically significant differences in reduction in pain intensity (p =.047), pain interference (p =.04), and pain-related disability (p =.028) between the qigong group and WLCG from baseline to postintervention were identified. Conclusion: Qigong is a mind–body approach to manage CLBP in veterans who receive care through the Veterans Health Administration and in the community. For future studies, a larger sample would provide a higher level of empirical evidence to support qigong practice for CLBP in veterans. Future studies should assess sustainability of the intervention. [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Despite the rapidly emerging evidence on the contributions of physical activity to improving cancer-related health outcomes, adherence to physical activity among young adults with lymphoma remains suboptimal. Guided by self-determination theory (SDT), the Lymfit intervention (a 12-week individualized exercise program with bi-weekly kinesiologist support and an activity tracker) aimed to foster autonomous motivation toward physical activity. This pilot randomized controlled trial aimed to evaluate the feasibility, acceptability, and preliminary effects of Lymfit. Young adults (N = 26; mean age of 32.1 years) with lymphoma who were newly diagnosed and those up to six months after completing treatment were recruited and randomly assigned one-to-one to either the intervention group (n = 13) or a wait-list control group (n = 13). All a priori feasibility benchmarks were met, confirming the feasibility of the study in terms of recruitment uptake, retention, questionnaire completion, intervention fidelity, missing data, Fitbit wear adherence, and control group design. The intervention acceptability assessment showed high ratings, with eight out of ten items receiving >80% high ratings. At post-intervention, an analysis of covariance models showed a clinically significant increase in self-reported physical activity levels, psychological need satisfaction, and exercise motivation in the intervention group compared to controls. Lymfit also led to meaningful changes in six quality-of-life domains in the intervention group, including anxiety, depression, fatigue, sleep disturbance, social roles and activities, and pain interference. The findings support Lymfit as a promising means to meet psychological needs and increase the autonomous motivation for physical activity in this group. A fully powered efficacy trial is warranted to assess the validity of these findings. [ABSTRACT FROM AUTHOR]

Background: There is inconsistent utilisation of clinical practice guidelines (CPGs) for cardiovascular disease (CVD) screening and management by healthcare professionals to identify CVD risk factors early and to intervene using current recommendations. To address this issue, the Cardiovascular Assessment Screening Program (CASP) was developed, implemented, and evaluated. This manuscript reports on the second phase of an exploratory sequential mixed methods study that tested the effectiveness of the CASP with nurse practitioners (NPs) and patients in Canada. Methods: A two-armed, non-blinded, cluster randomised controlled trial (cRCT) compared the NP-led implementation of CASP with usual care by NPs in community practice clinics across one Canadian province. The NPs were the cluster variable as their screening practices could be affected by their educational training, resources, or other factors. NPs were eligible for inclusion in the study if they were located in different urban and rural community settings and could conduct follow-up visits with patients. NPs recruited and enrolled the patients from their own practices as participants if they were healthy individuals, aged 40–74 years, with no established CVD or vascular disease. Researchers randomly allocated the NPs (n = 10) to the intervention group (IG) or the control group (CG). Results: Eight (8) NPs and 167 patients participated in the cRCT study. Patient participant-level data were analysed by the originally assigned groups IG (n = 68) and CG (n = 99). Utilising GLM (generalized linear modeling) more IG patients (90%; n = 61) received comprehensive CVD screening compared to the CG patients (2%; n = 2), RR = 30.2, 95% CI [8.76, 103.9], p <.0001, controlling for the effect of NP and BP category. Conclusion: NP implementation of CASP was effective for comprehensive screening compared to usual care and led to identifying previously unknown CVD risk factors, calculated FRS, heart health priorities and personalised goal-setting. Trial registration: ClinicalTrial.gov ID#: NCT03170752, date of registration 2017/05/31. [ABSTRACT FROM AUTHOR]

Background Among individuals with vitamin D deficiency, daily vitamin D supplementation appears to lower risk of acute respiratory infection. However, recent trials, in different populations and using different regimens, have yielded null results. We investigated the effect of daily vitamin D supplementation (vs placebo) on risk of upper respiratory infection (URI) in older adults. Methods The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial of supplemental vitamin D and/or omega-3 fatty acids in generally healthy men (age ≥50 years) and women (age ≥55 years). This prespecified analysis focuses on vitamin D3 (2000 IU/day) versus placebo in the 15 804 (61%) participants with baseline serum total 25-hydroxyvitamin D level. The primary outcome was self-report of a recent URI at 1-year follow-up. Results Participants had a mean age of 68 years and 51% were women; 76% were non-Hispanic White, 16% Black, and 8% other race/ethnicity. The mean 25-hydroxyvitamin D level at baseline was 31 (standard deviation, 10) ng/mL, with <12 ng/mL in 2.4%. The overall effect of vitamin D supplementation on recent URI was nonsignificant (odds ratio [OR], 0.96 [95% confidence interval {CI},.86–1.06]). In the prespecified subgroup of primary interest (<12 ng/mL and denied taking concurrent vitamin D), which had only 255 participants, vitamin D supplementation was nonsignificant (OR, 0.60 [95% CI,.28–1.30]). Statistical power to assess effect modification in other subgroups was limited. Conclusions In older adults not selected for vitamin D deficiency, supplemental vitamin D did not lower URI risk overall. Whether effects differ in subgroups requires further study. Clinical Trials Registration. NCT01169259. [ABSTRACT FROM AUTHOR]

Conventional treatments for allergic rhinitis (AR) exhibit insufficiency and long-term use-related side effects. Considering the reported anti-inflammatory and immunoregulatory effects of Bojungikgi-tang (BJIGT), we aimed to assess its efficacy on persistent AR (PAR). Patients with PAR were randomly assigned in a 1:1:1 ratio into high-dose BJIGT, standard-dose BJIGT, and placebo groups, followed by 1-week run-in and 4-week treatment periods. The primary outcome included the mean change in Total Nasal Symptom Score (TNSS), with secondary outcomes encompassing the Korean Allergic Rhinitis-Specific Quality of Life Questionnaire, biomarkers, overall assessment, TNSS by AR pattern identification, and the Sasang constitution. The mean TNSS change was more improved in the BJIGT group than in the placebo group; however, no statistically significant differences were observed. Additional interaction effect analysis revealed a statistically significant improvement in the high-dose BJIGT group compared with the placebo group from weeks 1–2 to weeks 3–4. Regarding secondary outcomes, the BJIGT group exhibited similar or improved results compared with the placebo group, showing no statistically significant differences. No serious adverse effects or clinically significant changes in safety assessments were observed. Given that this study validated clinical improvement and safety, it serves as potential groundwork for pertinent future studies. [ABSTRACT FROM AUTHOR]

Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate whether attentional control serves as a mediator for mindfulness‐based interventions for emotional distress, utilizing a randomized waitlist (WL)‐controlled design. Methods: A total of 498 participants with high emotional distress was recruited online and randomly assigned to a 49‐day online Mindfulness Intervention for Emotional Distress (MIED) group (N = 249) or a WL control group (N = 249). Levels of attentional control, anxiety and depression were assessed at baseline (T0), Week 3 (T3), Week 5 (T5) and Week 7 (postintervention, T7). Results: Linear mixed models revealed significant Group‐by‐Time interaction effects for attentional control (p < 0.001), anxiety (p < 0.001) and depression (p < 0.05). Latent growth curve analyses demonstrated a significant increase in attentional control and a decrease in anxiety and depression levels during the MIED programme. These changes becoming evident starting Week 3. Longitudinal mediation analyses revealed that the slope of attentional control significantly mediated the effects of the MIED programme on the slope of anxiety and depression levels. Further, attentional control level at Week 3 significantly mediates the effect of MIED programme on anxiety and depression levels at Weeks 5 and 7. Similarly, attentional control level at Week 5 significantly mediates the MIED programme's effects on anxiety and depression levels at Week 7. Conclusions: The present trial provides evidence suggesting that mindfulness interventions may alleviate emotional distress through the enhancement of attentional control. Trial Registration: Chinese Clinical Trial Registry number: ChiCTR2200064140 [ABSTRACT FROM AUTHOR]

* OBJECTIVE: To determine if adding lumbar neuromuscular control retraining exercises to a 12-week program of strengthening exercises had greater effect for improving disability than 12 weeks of strengthening exercises alone in people with chronic low back pain (LBP). * DESIGN: Single-center, participant- and assessor-blinded, comparative effectiveness randomized controlled trial. tMETHODS: Sixty-nine participants (31 females; 29 males; mean age: 46.5 years) with nonspecific chronic LBP were recruited for a 12-week program involving lumbar extension neuromuscular retraining in addition to resistance exercises (intervention) or 12 weeks of resistance exercises alone (control). The primary outcome measure was the Oswestry Disability Index. Secondary outcome measures included the Numeric Rating Scale, Tampa Scale for Kinesiophobia, Pain Self-Efficacy Questionnaire, and the International Physical Activity Questionnaire. Outcomes were measured at baseline, 6 weeks, and 12 weeks. * RESULTS: Forty-three participants (22 control, 21 intervention) completed all outcome measures at 6 and 12 weeks. Fourteen participants were lost to follow-up, and 12 participants discontinued due to COVID-19 restrictions. Both groups demonstrated clinically important changes in disability, pain intensity, and kinesiophobia. The difference between groups with respect to disability was imprecise and not clinically meaningful (mean difference, -4.4; 95% CI: -10.2, 1.4) at 12 weeks. Differences in secondary outcomes at 6 or 12 weeks were also small with wide confidence intervals. * CONCLUSIONS: Adding lumbar neuromuscular control retraining to a series of resistance exercises offered no additional benefit over resistance exercises alone over a 12-week period. [ABSTRACT FROM AUTHOR]

Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

BACKGROUND: Since the outbreak of the COVID-19 pandemic, university students have been exposed to a heightened vulnerability towards developing psychological issues, such as psychological distress and shyness. Internet-based interventions offer a convenient avenue for scalability, thus prompting the development of a smartphone-based hypnotic intervention aimed at addressing shyness among university students. OBJECTIVE: We devised an innovative smartphone-based hypnotic intervention called mHypnosis to examine its impact on shyness among undergraduate students. Furthermore, we aimed to investigate whether the apprehension of negative evaluations before treatment could serve as a predictor for the effectiveness of the intervention on shyness. METHODS: Eighty students with high shyness scores were randomly assigned to the experimental group and the control group. Another 40 participants with low shyness score were selected as the baseline group. The Shyness Scale (SS), Fear of Negative evaluation scale (FNE), Self-Acceptance Questionnaire (SAQ), and Self-Esteem Scale (SES) were used to evaluate the effect of hypnotic intervention. RESULTS: Before the intervention, the scores of the experimental and control groups on the SS, FNE, SAQ, and SES were higher than those in the baseline group (p < 0.05). There was no significant difference in scores between the experimental and control group (p > 0.05). After the intervention, the scores of the SS, FNE, SAQ, and SES were significantly lower in the experimental group than those in the control group (p < 0.05). The pretest score of FNE could predict the shyness score after hypnotic intervention (B = 0.35, p < 0.05). CONCLUSION: Smartphone-based hypnotic intervention had a significant effect on ameliorating shyness during the COVID-19 pandemic; fear of negative evaluation can be a target for treating shyness. [ABSTRACT FROM AUTHOR]

Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. R000038375 UMIN000033926 Individuals with stroke often collide with the paretic side while walking through narrow spaces. Training for walking through a narrow opening from the paretic side improved an individual's ability to avoid obstacles in similar tasks. Moreover, such training could improve patient outcomes/safety because such interventions may temporarily increase attentional focus to the paretic side in specific tasks. [ABSTRACT FROM AUTHOR]

Background: To evaluate the efficacy and safety of Keluoxin (KLX) capsules and provide validated evidence for the application of KLX in the treatment of diabetic kidney disease (DKD). Methods: A multicenter, randomized, double-blind, placebo-controlled trial design was used to screen 129 patients with DKD (urinary albumin-to-creatinine ratio [UACR]: male, 2.5–30 mg/mmol; female, 3.5–30 mg/mmol) and with Qi and Yin deficiency and blood stasis symptoms. Written informed consent was obtained from all patients. The patients were randomly divided into KLX and control groups. The KLX group was orally administered KLX (6 g/day) and irbesartan tablets (150 mg/day), whereas the control group was administered KLX placebo (6 g/day) and irbesartan tablets (150 mg/day). Patients were observed for 24 weeks to evaluate the natural logarithm of the UACR (log-UACR), the odds ratio (OR) for a sustained increase in the UACR of at least 30% and 40%, estimated glomerular filtration rate (eGFR), changes in symptoms and quality–of-life scores, and adverse events. Results: The changes of the natural log-UACR during the 24 weeks compared with baseline in the KLX group were better than those in the control group (LS mean ± standard error, −0.26 ± 0.10 vs. 0.01 ± 0.09, p = 0.0292). The incidence of a sustained increase in the UACR of at least 30% and 40% was found to be significantly lower in the KLX group (OR, 0.26; 95% confidence interval [CI], 0.09–0.75; OR, 0.29; 95% CI, 0.10–0.82). Changes in symptoms and quality-of-life scores in the KLX group were better than those in the control group. There was no statistically significant difference in eGFR or the incidence of adverse events between the groups. Conclusions: Overall, these results suggest that KLX capsules combined with irbesartan can reduce microalbuminuria, relieve the symptoms, and improve the quality of life for patients with type 2 early DKD compared with the use of irbesartan alone. Trial registration: Chinese Clinical Trial Registry, registration number: ChiCTR2100052764. [ABSTRACT FROM AUTHOR]

Background: Central obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture. Method: This was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period. Results: The acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups. Conclusion: This study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio. Trial registration: ClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019. [ABSTRACT FROM AUTHOR]

Background: This study aims to assess the efficacy and safety of Qingpeng ointment (QPO), a Tibetan medicine for alleviating symptoms in individuals with acute gouty arthritis (AGA). Methods: This study was a randomized, double-blind, placebo-controlled trial that involved individuals with AGA whose joint pain, as measured on a visual analog scale (VAS) from 0 to 10, was equal to or greater than 3. The participants were randomly assigned to either the QPO or the placebo group and received their respective treatments twice daily for seven consecutive days. In case of intolerable pain, the participants were allowed to use diclofenac sodium sustained-release tablets as a rescue medicine. The primary outcomes measured were joint pain and swelling, while the secondary outcomes included joint mobility, redness, serum uric acid levels, C-reactive protein levels, and the amount of remaining rescue medicine. Any adverse events that occurred during the trial were also recorded. Results: A total of 203 cases were divided into two groups, with balanced baselines: 102 in the QPO group and 101 in the placebo group. For joint pain, differences between the groups were notable in the VAS scores [1.75 (0, 3.00) versus 2.00 (1.00, 3.50); P = 0.038], changes in VAS [5.00 (3.00, 6.00) versus 4.00 (2.00, 6.00); P = 0.036], and disappearance rate [26.47% compared to 15.84%; P = 0.046] after treatment. Concerning joint swelling, significant between-group differences were observed in the VAS scores [1.00 (0, 2.30) versus 2.00 (0.70, 3.00); P = 0.032] and disappearance rate [33.33% compared to 21.78%; P = 0.046] at treatment completion. The QPO group exhibited a statistically significant mobility improvement compared to the placebo group (P = 0.004). No significant differences were found in other secondary outcomes. Five patients, four from the QPO group and one from the other, encountered mild adverse events, primarily skin irritation. All of these cases were resolved after dosage reduction or discontinuation of the medication. Conclusions: Compared to the placebo, QPO exhibits positive effects on AGA by alleviating pain, reducing swelling, and enhancing joint mobility, without causing significant adverse effects. Trial Registration: ISRCTN34355813. Registered on 25/01/2021. [ABSTRACT FROM AUTHOR]

This study sought to evaluate the impact of the subcutaneous tunneling technique on peripherally inserted central catheter (PICC) placement. We randomized 694 patients who needed PICC placement to either the tunneled PICCs (experimental group) or the non-tunneled PICCs (control group) from August to December 2021. The cumulative frequency of complications was assessed as the primary outcome. Secondary outcomes comprised of the amount of bleeding, catheter insertion time, self-reported pain score, and one-puncture success rate. After 6 months of follow-up, the tunneled PICCs group showed a significant decrease in the frequency of total complications, especially in infection (3.0% vs. 7.1%, p =.021) and catheter-related thrombosis (3.3% vs. 8.3%, p =.008), although approximately 0.5 ml bleeding and 3.5 min time were increased. This randomized multicenter study supports the efficacy of subcutaneous tunneling technology in reducing PICC-related complications, enhancing patient comfort, and encouraging using subcutaneous tunneling technology for PICC placement. [ABSTRACT FROM AUTHOR]

Purpose: This study compared the effectiveness of age‐appropriate, high technology, interactive virtual reality (VR) distraction with standard care (SC) provided by the nurse on adolescents' acute procedural pain intensity perception during burn wound care treatment in the ambulatory clinic setting. Design: This randomized controlled trial included 43 adolescents ages 10–21 from the ambulatory burn clinic of a large children's hospital. Methods: Blinded study participants were randomly assigned to either VR or SC (non‐significantly different, current mean burn surface area, 1.3 and 1.7, respectively) during the first burn wound care procedure in the burn clinic. Blinded research staff collected pre‐procedure data including Spielberger's State‐Trait Anxiety Inventory and postprocedure wound care pain intensity using the Adolescent Pediatric Pain Tool. A total of 41 participants completed all study procedures. Results: No statistically significant difference in burn wound care procedural pain was noted between the VR and SC groups after adjusting for several factors. Pre‐procedure state and trait anxiety correlated with reported pre‐procedure pain. Wound care pain was found to be significantly associated with pre‐wound care pain score, time from original burn to clinic burn care treatment, and length of wound care treatment. These factors accounted for approximately 45% of the variation in pain scores during wound care treatment. Practice Implications: VR distraction can be a useful pain management strategy but may not take the place of the unique nurse‐patient relationship that occurs during clinical encounters. Tailoring pain management during burn wound care requires consideration of anxiety, time from the burn injury to the wound care procedure, length of time of the wound care procedure, and pretreatment pain level. Knowing patients' needs, desires, and temperaments along with the specifics about the healthcare procedures are critical to formulating individualized care plans that may or may not include VR. Newer technology, such as easier‐to‐use, less expensive VR, may assist with translation into practice making its clinical use more routine. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to develop a mobile application for improving self‐management and to evaluate its effects in adult patients on peritoneal dialysis (PD). Methods: This randomized controlled trial was registered with the Korean Clinical Research Information Service Registry (KCT0007267) and conducted at a tertiary hospital. A self‐management mobile application (SMA) was developed based on social cognitive theory and the ADDIE (analysis, design, development, implementation, and evaluation) model. The SMA includes information about disease management; self‐recording of data on diet, exercise, medication, and health behavior; and healthcare providers' support and feedback. Participants aged 19–65 years were randomly allocated to the intervention group (n = 27) using the SMA for 10 weeks, and the control group (n = 26) receiving usual care. PD‐related knowledge and self‐efficacy, PD‐related health behavior, biomarkers, and health‐related quality of life (HRQoL) were surveyed pretest/posttest and analyzed using SPSS 23.0. Results: Compared to the controls, the intervention group showed significant improvement in PD‐related knowledge and health behavior, albumin, and hemoglobin. HRQoL domains of symptoms/problems of kidney disease and disease impact on daily activity were improved in the intervention group. Conclusion: The SMA is an effective intervention for enhancing health behaviors as well as improving the HRQoL of patients with PD. Without any limitations on time or location, patients with PD can easily use the SMA to monitor their health conditions, efficiently manage their disease, and perform PD‐related behaviors. Nurses can implement high‐quality tailored healthcare by using patients' lifelog data from the SMA. [ABSTRACT FROM AUTHOR]

A semistructured preschool motor program was developed in response to the paucity of evidence-based motor programs for preschoolers with disabilities in inclusive classrooms. A randomized controlled trial (RCT) was undertaken to examine the impact of the CHildren in Action: Motor Program for PreschoolerS (CHAMPPS), a 21-week intervention that includes 42 Universal Design for Learning–embedded lessons with suggestions for supporting school readiness skills. Eight intervention and 8 control classrooms across 2 states participated in the RCT. Data on 51 children with disabilities provide initial evidence on how CHAMPPS positively impacted children's active engagement, motor, and social development. The promising results include gains in motor skills, sustained physical activity levels during motor play, increased on-task behavior, and high feasibility and usability ratings by teachers. Implications for practice and future research are discussed. [ABSTRACT FROM AUTHOR]

Children's burns are a major public health concern due to their long‐term physical, psychological, and social impacts, as well as their high financial burden. This study aimed to evaluate the effectiveness of a smartphone‐based educational program on outcomes of children with severe burns. This study was designed as a double‐blinded, randomized controlled trial (RCT) to test the effectiveness of a developed mobile application. A total of 93 participants were included in the final analysis. The participants were randomly assigned to either the intervention or control groups. Participants in both groups received usual self‐care training at discharge, but those in the intervention group used an Android‐based application for 2 months. The primary goal of the burn application was scar recovery, and the secondary goals were to increase child caregivers' satisfaction rate and decrease unplanned hospital readmissions. Data collection was conducted using valid and reliable questionnaires. Data were analysed using SPSS software. The study showed that the mobile application significantly affected the frequency of patient visits to the burn clinic and the satisfaction of caregivers of children with burns with the treatment process (p‐value <0.05). Also, there was a significant relationship between the duration of application use and wound healing status ((p‐value <0.001). These findings suggest that smartphone‐based educational programs can be valuable for optimizing care for children with severe burns. Further research is warranted to explore the long‐term impact of this intervention and its potential application in different healthcare settings. [ABSTRACT FROM AUTHOR]

Although swallowing exercises are a fundamental treatment for dysphagia, few studies have evaluated the effectiveness of swallowing training in patients with Alzheimer's disease. We recruited 93 patients with Alzheimer's disease from three hospitals in Guangdong, China. This was a parallel armed randomized controlled trial that randomly assigned patients to intervention (n = 48) and control (n = 45) groups. The intervention group adopted systematic stepwise swallowing training for four weeks based on routine dysphagia care. The control group implemented routine dysphagia care, including diet and posture management and health education about swallowing dysfunction. The swallowing function was the primary outcome, which was assessed using the Water Swallowing Test and Standard Swallowing Assessment. An abnormal eating behavior questionnaire was used to assess the incidence of aberrant eating behavior in patients with Alzheimer's disease. The Mini-Nutritional Assessment Short Form and Barthel index were adopted to evaluate the nutritional status and ability to carry out daily activities between groups. SPSS software was used to perform the chi-square test, t -test, and generalized estimation equation for data analysis. We analyzed the effects of the stepwise swallowing training program using the generalized estimating equation method. The intervention group exhibited greater improvements in their swallowing function (Water Swallowing Test: β = − 3.133, 95 % CI: − 4.113, − 2.154, P < 0.001; Standard Swallowing Assessment: β = − 5.813, 95 % CI: − 7.782, − 3.844, P < 0.001), abnormal eating behaviors (abnormal eating behavior questionnaire: β = − 13.324, 95 % CI: − 21.643, − 5.005, P = 0.002), daily function (Barthel index: β = 11.280, 95 % CI: 4.021, 18.540, P = 0.002), and nutritional status (Mini-Nutritional Assessment Short Form: β = 2.402, 95 % CI: 1.313, 3.490, P < 0.001) over time than the routine-care group in the fourth week. Stepwise swallowing training is a safe and effective intervention for managing dysphagia and other related symptoms in patients with Alzheimer's disease. [ABSTRACT FROM AUTHOR]