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This randomized controlled trial aimed to assess the efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered cognitive-emotional intervention, among the homebound older population presenting with mild cognitive impairment and depressive or anxiety symptoms. Participants were randomly assigned either to the intervention group or the treatment-as-usual group and completed baseline, post-intervention, and three-month follow-up assessments. Changes in episodic memory and symptoms of depression and anxiety were the primary outcomes. Secondary outcomes included changes in global cognition, attentional control, subjective memory complaints, functional status, and quality of life. Data were analyzed on an intention-to-treat basis employing a linear mixed models approach. ClinicalTrials.gov identifier: NCT05499767. Compared with the treatment-as-usual group, the HEPPI group reported significant immediate improvement in cognition, mood, and daily functional performance. Positive effects of HEPPI were maintained over the follow-up phase only in depressive symptomatology, perceived incapacity to perform advanced instrumental activities of daily living, and self-reported emotional ability. A significant impact of the intervention on the subjective memory complaints level was observed only three months after the intervention. This study suggests that HEPPI may be a promising home-delivered cognitive-emotional intervention to help homebound older adults improve their mental health. [ABSTRACT FROM AUTHOR]

Objective: Limited studies have yet evaluated the effectiveness of topiramate in the treatment of amphetamine and methamphetamine addiction. Therefore, the aim of this study was to investigate the effectiveness of topiramate in the treatment of patients with this disorder. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 52 patients with amphetamine and methamphetamine use disorder, within the age range of 16-60 years, were randomly divided into an intervention group (n = 26) and a placebo group (n = 26). The intervention group was treated with topiramate tablets with a starting dose of 50 mg, which was gradually increased to the target dose of 200 mg. The control group was treated with placebo. The duration of drug intervention in this clinical trial was 12 weeks, and all participants were evaluated before the intervention and 2, 4, 6, 8, 10, and 12 weeks after beginning the intervention. The Beck Depression Inventory, drug use temptation questionnaire, urine test, and side effects questionnaire were used as outcome measures to assess the patients. The data were analyzed using chi-square, independent t-test, and analysis of variance with repeated measurements. Results: There was no significant difference between the intervention and placebo groups in depression at the beginning of the treatment and at the 4th, 8th, and 12th weeks after the intervention (P > 0.05). The urine test also showed no significant difference between the two groups at any of the evaluation stages (P > 0.05). Although there was no significant difference between the two groups in the drug use temptation results at the beginning and the 2nd, 4th and 6th weeks (P > 0.05), the level of drug temptation in the intervention group was significantly lower than the placebo group in the 8th, 10th, and 12th weeks (P < 0.05). Conclusion: Topiramate can be effective in reducing the desire to use amphetamine and methamphetamine. However, further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Aims Burns and wounds caused by it are a global injury. Finding natural ingredients to accelerate wound healing in patients with fewer side effects could be valuable. This study aimed to determine the effect of oral Centella asiatica extract on the healing of pain and wound of burn in patients. Materials & Methods This study is a clinical trial in which 76 patients hospitalized in the burn department were randomly divided into two intervention (n=38) and control (n=38) groups. The intervention group, in addition to the usual antibiotic treatments, received capsules containing 200mg of Centella asiatica twice daily, and the control group received capsules containing 200mg of starch twice daily. Data collection tools were Bates-Jensen Wound Assessment tool and Visual Analog Scale. Patients' pain and wound healing status were examined at different time of the study. Findings The mean burn pain score showed a significant improvement in the intervention group compared to the control group (p<0.001). The average wound healing score did not show significant improvement in the intervention group compared to the control group (p=0.561). However, size (p=0.023), the degree of destruction of the underlying tissues (p=0.032), the amount of necrotic tissue (p=0.015), and the amount of granulation tissue (p=0.001) improved significantly in the intervention group. In addition, the peripheral tissue edema in the control group decrease significantly compared to the intervention group (p=0.008). Conclusion Oral extract of Centella asiatica reduces pain in burn patients. However, it does not affect wound healing, although it improves some wound healing indicators. [ABSTRACT FROM AUTHOR]

Background: Frailty is associated with poor outcomes among older adults with hypertension and complicates its pharmacological management. Here, we assessed whether 12-weeks of instructor-guided, group Tai Chi (TC) practice improved frailty relative to Healthy Aging Practice-centered Education (HAP-E) classes in older adults with hypertension. Methods: Secondary analysis of a randomized controlled trial in San Diego County, USA, of 167 community-dwelling individuals aged ≥ 60 yrs (70% female; 72.1 ± 7.5 yrs), defined as non-frail (66%) or frail (34%) based on 53-item deficit accumulation frailty index (FI). Linear mixed-effects models were used to assess pre-to-post intervention differences in FI and logistic regression to explore differential odds of clinically meaningful FI change. Results: One hundred thirty-one participants completed post-intervention assessments. Frailty decreased pre-to-post intervention in the TC (ΔFI = − 0.016, d = − 0.39, − 0.75 to − 0.03), but not the HAP-E arm (ΔFI = − 0.009, d = − 0.13, − 0.52–0.27), despite no significant group differences between the TC and HAP-E arms (d = − 0.11, − 0.46–0.23). Furthermore, greater odds of improved FI were observed for frail participants in the TC (OR = 3.84, 1.14–14.9), but not the HAP-E (OR = 1.34, 0.39–4.56) arm. Subgroup analysis indicated treatment effects in TC were attributed to frail participants (frail: ΔFI = − 0.035, d = − 0.68, -1.26 to − 0.08; non-frail: ΔFI = − 0.005, d = − 0.19, − 0.59–0.22), which was not the case in the HAP-E arm (frail: ΔFI = − 0.017, d = − 0.23, − 0.81–0.35; non-frail: ΔFI = − 0.003, d = − 0.07, − 0.47–0.33). Frail participants were no more likely to drop-out of the study than non-frail (71% vs. 69% retained). Conclusions: Twelve weeks of twice-weekly guided TC practice was well-tolerated, associated with decreases in frailty, and increased odds of clinically meaningful FI improvement at post-intervention. [ABSTRACT FROM AUTHOR]

Background: Oxaliplatin-based chemotherapy is a major first-line conventional therapy for advanced and metastatic colorectal cancer (CRC). However, oxaliplatin causes chemotherapy-induced peripheral neuropathy (CIPN). Acupuncture has long been used to alleviate limb numbness in Chinese medicine practice. Aim: The aim of this study was to examine the efficacy and safety of electroacupuncture (EA) for the alleviation of CIPN in CRC patients. Design: This was a pilot single-blinded, randomized, sham-controlled trial. Setting/participants: Sixty eligible patients, who had been diagnosed with CRC and were undergoing oxaliplatin-based chemotherapy, were randomized in a ratio of 1:1 to the EA intervention group or sham acupuncture (SA) control group. During a 12-week treatment period, patients in the EA group received EA once a week, while patients in the SA group received SA; both groups were followed up for 12 weeks. Results: Compared with the SA group, the EA group exhibited significant alleviation of CIPN severity during chemotherapy. Moreover, EA also improved the physical function, role function, and social function of CRC patients. However, there were no significant differences in tests of vibration or light touch sensation. In addition, EA appeared to be a safe treatment for CIPN and was both feasible and acceptable to CRC patients during chemotherapy. Conclusion: This study showed preliminary evidence for the efficacy and safety of EA in acute CIPN among CRC patients, although further studies are needed to verify these effects and to further explore the potential role of EA in chronic CIPN (effects on which remain unclear). Trial registration number: NCT03582423 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Background: The risk of postoperative cognitive dysfunction(POCD) in laparoscopic surgery should not be overlooked. Intravenous lidocaine can reduce perioperative inflammatory response in patients undergoing laparoscopic surgery, while the effect of intraoperative intravenous lidocaine on postoperative cognitive function in patients undergoing laparoscopic colorectal cancer surgery has not been well studied. We investigated whether intraoperative lidocaine improves postoperative cognitive function after laparoscopic radical resection for colorectal cancer. Methods: We conducted a prospective, randomized double blinded controlled trial to investigate the effect of intravenous lidocaine on rapid postoperative recovery in patients undergoing laparoscopic radical resection of colorectal cancer. The patients were randomly assigned to receive either intravenous lidocaine or saline. The primary outcome was cognitive dysfunction defined by a decrease from pre- to postoperative ≥ 2 of the Mini-Mental State Examination (MMSE) score, at the 3rd and the 7th postoperative days. Secondary outcomes were the MMSE raw score and parameters of the patients' postoperative recovery such as agitation and length of stay in the post-anaesthesia care unit (PACU), length of hospital stay, markers of inflammation (white blood cell count and CRP), and incidence of complications. Results: Seventy-three patients in the lidocaine group and 77 patients in the control group completed the trial. The rate of cognitive dysfunction was lower in the lidocaine group than that in the control group, both at the 3rd (18.57% vs. 63.64% for each group respectively; RR = 0.26, 95%CI = 0.19–0.32; p < 0.0001) and at the 7th postoperative day (12.33% vs. 53.25% for each group respectively; RR = 0.28, 95%CI = 0.22–0.35; P < 0.001). The postoperative MMSE scores were also higher in the lidocaine group than in the control group both at the 3rd (median 25 vs. 24 respectively) and at the 7th postoperative day (26 vs. 24 respectively). Also, patients in the lidocaine group displayed a lower white blood cell count than the control group at the 1st postoperative day (8.5 ± 2.7 vs. 10.4 ± 3.3; p < 0. 001). No differences were evidenced for the other secondary outcomes. Conclusions: Intraoperative intravenous lidocaine can significantly improve postoperative cognitive function in patients undergoing laparoscopic radical resection of colorectal cancer. Trial registration: Chinese Clinical Trial Registry (16/1/2022, registration number: ChiCTR2200055683) [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) on upper limb motor recovery during post-stroke rehabilitation. Design: Single-blind, randomized controlled trial. Setting: Four inpatient rehabilitation facilities. Subjects: A total of 204 stroke patients with unilateral upper limb motor impairment were randomly 1:1 allocated to TEAS or sham TEAS group. Baseline demographic and clinical characteristics were comparable between the two groups. Interventions: Both groups received conventional physical and occupational therapies. TEAS and sham TEAS therapy were administered to two acupoints (LI10 and TE5) with a pulse duration of 300 µ s at 2 Hz on the affected forearm for 30 times over 6 weeks. Outcome measures: The upper-extremity Fugl-Meyer score (primary outcome), manual muscle testing, modified Ashworth scale, Lindmark hand function score, and Barthel index were evaluated by blinded assessors at baseline, 2, 4, 6, 10, and 18 weeks. Results: The number of patients who completed the treatment was 99 and 97 in the TEAS and the sham group. No significant between-group difference was found in the Upper-Extremity Fugl-Meyer score, Modified Ashworth Scale, Lindmark hand function score, and Barthel Index after intervention and during follow-up. However, the TEAS group exhibited 0.29 (95% CI 0.02 to 0.55) greater improvements in Manual Muscle Testing of wrist extension than the sham group (p = 0.037) at 18 weeks. Conclusions: Administration of TEAS therapy to hemiplegic forearm could not improve the upper extremity motor recovery. However, TEAS on the forearm might provide potential benefits for strength improvement of the wrist [ABSTRACT FROM AUTHOR]

Background: When stable osteochondritis dissecans (OCD) lesions of the femoral condyle in a skeletally immature patient fail to heal with nonoperative methods, the standard of care treatment is condylar OCD drilling. Two primary OCD drilling techniques have been described, but no prospective studies have compared their relative effectiveness. Purpose/Hypothesis: The purpose of this study was to compare the healing and function after transarticular drilling (TAD) with that after retroarticular drilling (RAD). It was hypothesized that there would be no difference in rate or time to healing, rate or time to return to sports, patient-reported outcomes (PROs), or secondary OCD-related surgery. Study Design: Randomized controlled clinical trial; Level of evidence, 1. Methods: Skeletally immature patients with magnetic resonance imaging–confirmed stable OCD lesions of the medial femoral condyle who did not demonstrate substantial healing after a minimum of 3 months of nonoperative treatment were prospectively enrolled by 1 of 17 surgeon-investigators at 1 of 14 centers. Patients were randomized to the TAD or RAD group. Tourniquet time, fluoroscopy time, and complications were compared between the treatment groups. Postoperatively, serial radiographs were obtained every 6 weeks to assess healing, and PROs were obtained at 6 months, 12 months, and 24 months. Results: A total of 91 patients were included, consisting of 51 patients in the TAD and 40 patients in the RAD group, who were similar in age, sex distribution, and 2-year PRO response rate. Tourniquet time and fluoroscopy time were significantly shorter with TAD (mean, 38.1 minutes and 0.85 minutes, respectively) than RAD (mean, 48.2 minutes and 1.34 minutes respectively) (P =.02; P =.004). In the RAD group, chondral injury from K-wire passage into the intra-articular space was reported in 9 of 40 (22%) patients, but no associated postoperative clinical sequelae were identified in these patients. No significant differences between groups were detected in follow-up Pediatric–International Knee Documentation Committee, Lysholm, Marx Activity Scale, or Knee injury and Osteoarthritis Outcome Score Quality of Life scores. Healing parameters were superior at 6 months and 12 months in the TAD group, compared with the RAD group, and secondary OCD surgery occurred in 4% of patients who underwent TAD and 10% of patients who underwent RAD (P =.40). Patients in the TAD group returned to sports earlier than those in the RAD group (P =.049). Conclusion: TAD showed shorter operative time and fluoroscopy time and superior healing parameters at 6 and 12 months, but no differences were seen in 24-month healing parameters or PROs at all follow-up time points, when compared with RAD. Registration: NCT01754298 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Despite overwhelming adoption of wearable fitness trackers (WFT), it is unclear if they affect physical activity (PA) engagement or PA motivation. We hypothesized that combining a WFT with an effective intervention, motivational interviewing (MI), would positively influence both motivation and PA. A 12-week randomized controlled trial was conducted in 40 adults who did not meet PA recommendations. The four conditions were: a PA education (Educational control, n = 10), a WFT (WFT, n = 10), bi-weekly MI sessions (MI, n = 10), or both interventions (WFT+, n = 10). Motivation and PA were measured through an online survey and actigraphy pre- and post-intervention. Both the WFT+ and MI groups improved autonomous forms and decreased controlled forms of motivation. They also had higher basic psychological needs scores when compared to the Education group post-intervention. We detected no changes in PA. High autonomous motivation at baseline predicted higher post-intervention PA in the WFT+ group but predicted lower post-intervention PA in the WFT group. Results suggests that MI alone or with a WFT can improve basic psychological needs and autonomous forms of motivation for PA, but not PA participation. Individual differences in motivation at baseline may moderate the effect of a WFT on PA. This study was registered at clinicaltrials.gov (NCT490014). [ABSTRACT FROM AUTHOR]

It is believed that clinical management of osteoarthritis should address muscle weakness to improve physical function and prevent disability and frailty This sub-study investigated the effects of supervised progressive resistance training (RT), supervised Nordic Walking (NW), and unsupervised home-based exercise (HBE) on muscle and functional performance; and associations between these exercise-induced changes in persons with hip osteoarthritis. Forty-two patients with hip osteoarthritis were recruited from a larger RCT (NCT01387867). All the groups (RT, n = 15; NW, n = 12; HBE, n = 15) exercised 1 h 3 times/week for 4 months. Quadriceps cross-sectional area (QCSA, MRI-determined); quadriceps strength (QMVC); leg extensor power (LEP); functional performance (chair stands (30sCS); stair climbs (TSC); and 6-minute walk (6MWT)) were assessed at baseline and 4 months. Per protocol analyses (one-way ANOVA and Bonferroni test) showed significant between-group differences for improvements in QCSA in the most symptomatic leg favoring RT versus NW (2.3 cm2, 95% CI [0.6, 3.9]) and HBE (2.3 cm2 [0.8, 3.9]); and 30sCS (1.8 repetitions [0.2–3.3]), and 6MWT (35.1 m [3.5–66.7]) favoring NW versus HBE. Associations existed between exercise-induced changes in QCSA and QMVC (r = 0.366, p =.019) for the most symptomatic leg and between changes in 6MWT and QMVC (r = 0.320, p =.04) and LEP (r = 0.381, p =.01), respectively, for the least symptomatic leg. Resistance training appeared effective for improving muscle mass, but less effective for improving muscle strength, power, and functional performance. Only exercise-induced changes in muscle strength and power of the least symptomatic leg, not the most symptomatic leg, were related to changes in functional performance. [ABSTRACT FROM AUTHOR]

Purpose: We examined the effectiveness of the "positive diary," in which family caregivers of people with dementia write down three good things that happened with reasons at the end of each day. Design and Methods: In this randomized controlled trial, the intervention group used the "positive diary," while the control group kept a record of each meal for 4 weeks. Findings: The intervention group showed improvement on several measures of wellbeing including Neuropsychiatric Inventory Questionnaire and Center for Epidemiologic Studies Depression Scale. Practice Implications: The "positive diary" is a useful self‐care tool for caregivers of people with dementia. [ABSTRACT FROM AUTHOR]

Objective: Many individuals with an eating disorder do not receive appropriate care. Low‐threshold interventions could help bridge this treatment gap. The study aim was to evaluate the effectiveness of Featback, a fully automated online self‐help intervention, online expert‐patient support and their combination. Method: A randomized controlled trial with a 12‐month follow‐up period was conducted. Participants aged 16 or older with at least mild eating disorder symptoms were randomized to four conditions: (1) Featback, a fully automated online self‐help intervention, (2) chat or email support from a recovered expert patient, (3) Featback with expert‐patient support and (4) a waiting list control condition. The intervention period was 8 weeks and there was a total of six online assessments. The main outcome constituted reduction of eating disorder symptoms over time. Results: Three hundred fifty five participants, of whom 43% had never received eating disorder treatment, were randomized. The three active interventions were superior to a waitlist in reducing eating disorder symptoms (d = −0.38), with no significant difference in effectiveness between the three interventions. Participants in conditions with expert‐patient support were more satisfied with the intervention. Discussion: Internet‐based self‐help, expert‐patient support and their combination were effective in reducing eating disorder symptoms compared to a waiting list control condition. Guidance improved satisfaction with the internet intervention but not its effectiveness. Low‐threshold interventions such as Featback and expert‐patient support can reduce eating disorder symptoms and reach the large group of underserved individuals, complementing existing forms of eating disorder treatment. Public significance statement: Individuals with eating‐related problems who received (1) a fully automated internet‐based intervention, (2) chat and e‐mail support by a recovered individual or (3) their combination, experienced stronger reductions in eating disorder symptoms than those who received (4) usual care. Such brief and easy‐access interventions play an important role in reaching individuals who are currently not reached by other forms of treatment. [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]

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]

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 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]

Background: Auricular acupressure (AA) has been viewed as a promising approach to managing chemotherapy-induced nausea and vomiting (CINV) but relevant research evidence has been inconclusive. This study aimed to examine the effects of AA on CINV in breast cancer (BC) patients undergoing chemotherapy. Methods: A preliminary randomized controlled trial was conducted in 114 BC patients. Participants were randomly allocated to a true AA group (n = 38), a sham AA group (n = 38), and a standard care group (n = 38). All the participants were provided with standard antiemetic treatment and care, while the true AA group and the sham AA group received an additional 5-day true AA and a 5-day sham AA, respectively. Acute and delayed CINV were assessed by using the MASCC Antiemesis Tool (MAT), anticipatory nausea and vomiting were measured by the Index of Nausea, Vomiting, and Retching (INVR), and patients' quality of life (QoL) was evaluated by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Results: Both the true and sham AA groups reported improved CINV outcomes than the standard care group, with the true AA demonstrating larger effects than the sham comparison. The true and sham AA groups had higher complete response (CR) rates of CINV when compared with the standard care group, with the difference in the CR of acute CINV achieving statistical significance (p = 0.03). Both the true and sham AA groups demonstrated lower incidence and severity of acute CINV compared with the standard care group with the among-group difference reaching statistical significance for the occurrence (p = 0.04) and severity (p = 0.001) of acute nausea. No significant differences in anticipatory CINV and QoL were found among the groups. Conclusion: The use of AA plus standard antiemetic treatment and care was superior to the use of standard antiemetic treatment and care alone in managing CINV among BC patients receiving chemotherapy. The antiemetic effects of AA were identified to be more profound in improving acute CINV, particularly acute nausea. The antiemetic effects of AA were deemed to be a mixture of specific treatment effects and placebo effects, and the placebo effects were very large and even reached clinical significance. Trial registration: ClinicalTrials.gov; NCT02403037; Registered March 31, 2015. [ABSTRACT FROM AUTHOR]

Background: There is insufficient study using Kinesio taping (KT) in bladder problems. Objectives: To investigate the effects of pelvic floor muscle training (PFMT) combined with KT on bladder symptoms, pelvic floor muscle strength, and quality of life in women with overactive bladder (OAB) syndrome and compare this combination with PFMT plus sham tape (ST). Methods: Women with OAB were randomly allocated into PFMT+KT and PFMT+ST groups. All patients were given PFMT for 6 weeks and applied taping according to groups. Before and after treatment, the OAB symptoms with the Overactive Bladder Assessment Form (OAB-V8) and Patients' Perception of Intensity of Urgency Scale (PPIUS), bladder function with a 3-day voiding diary, pelvic floor muscle strength with the Modified Oxford Scale, and quality of life with the King's Health Questionnaire (KHQ) were assessed. Results: OAB-V8, PPIUS, and KHQ scores decreased and the MOS improved in both groups (P <.05) after treatment. The intergroup comparisons revealed a further decrease in voids/day, voids/night, incontinence episodes/day, and personal limitation scores of the KHQ in the PFMT+KT group compared to the PFMT+ST group (P <.05). Conclusion: PFMT+KT was more effective in reducing the OAB symptoms compared to PFMT+ST. KT could be a complementary application for reducing symptoms in OAB. [ABSTRACT FROM AUTHOR]

Coronary artery bypass grafting is considered to be a more effective surgical procedure for the long-term benefits of people with obstructed coronary artery than other types of treatment. Yet, this measure does not provide an equally successful outcome for all people due to associated psychological and physical impediments. There is a lack of support programs in Bangladesh for people with coronary artery bypass grafting, and for this reason this randomized control trialled investigated the effectiveness of a healthy heart intervention program on the functional status and cardiac risk parameters among these people. A total of 160 participants with coronary artery disease were admitted to a specialized cardiac hospital in Dhaka for bypass grafting and they were randomly assigned to the experimental (n=80) and control group (n=80). The experimental group participated in the healthy heart intervention program in the hospital for 4 weeks in addition to routine care and also received follow-up phone calls at home after hospital discharge, while the control group received only routine hospital care. The data collection tools included demographic data and the health history questionnaire, the Bengali version of SF-36, and the cardiac risk assessment form. The outcomes of the program were measured at baseline, and at 12 and 16 weeks. Data analysis was performed using descriptive statistics, t-test, chi-square, and two-way repeated measures ANOVA. At baseline, there were no statistically significant differences between the groups in terms of demographic characteristics, health history, functional status, or risk parameters. The mean score for functional status was significantly higher, and the risk parameters for blood pressure and blood glucose were significantly lower in the experimental group than the scores in the control group at twelve and sixteen weeks. The healthy heart intervention program was seen to be useful for improving the functional status and reducing the risk parameters of individuals that have undergone coronary artery bypass grafts. The findings provide evidence for reforming the healthcare of the target population and for further research in order to validate the results before implementation in practice. [ABSTRACT FROM AUTHOR]

Background: Training conversation partners of people with aphasia who use facilitative communication strategies is one method that can improve access to healthcare for people with aphasia. However, the efficacy of communication partner training (CPT) has been investigated almost exclusively in the context of face‐to‐face (F2F) delivery. Online training may offer more cost‐effective and accessible options to a wider range of conversation partners, including student healthcare professionals. Aims: To conduct a pilot randomized controlled trial with student healthcare professionals comparing (1) an online aphasia CPT program, (2) a F2F CPT program and (3) no program (control group) on outcomes relating to attitudes and knowledge of aphasia. Methods & Procedures: A 45‐min introductory aphasia CPT program was developed using the theories and techniques of Supported Conversations for Adults with Aphasia (SCA)™. A total of 30 first‐year undergraduates studying occupational therapy at The University of Sydney were randomly allocated to one of three conditions: online CPT delivery, F2F delivery or delayed training control (no program). Outcomes measures included pre‐post‐testing with the Aphasia Attitudes, Strategies and Knowledge (AASK) survey. Outcomes & Results: A significant difference existed for the AASK survey pre‐post‐change scores between the online, F2F and control groups (χ2(2) = 20.038, p = 0.000). Post‐hoc analysis revealed that, compared with the control (Ctrl) group, participants in both the online and F2F groups had significantly higher knowledge of aphasia (Online versus Ctrl: p = 0.000; F2F versus control: p = 0.002), knowledge of facilitative strategies (Online versus Ctrl: p = 0.000; F2F versus Ctrl: p = 0.002), and positive attitudes towards aphasia (Online versus Ctrl: p = 0.031; F2F versus Ctrl: p = 0.032). No significant difference was observed between the online and F2F groups for the Total or any subtotals (p = 1.000). Conclusions and Implications: The results from this pilot randomized controlled trial indicate that online delivery of the 45‐min introductory CPT is equally as efficacious as F2F delivery, and thus may be a viable mode of delivery for future aphasia CPT programs. These pilot results pave the way for a larger study that will comprehensively evaluate the efficacy of an online aphasia CPT program for improving attitudes, knowledge and skills in a broad range of student healthcare professionals. What this paper addsWhat is already known on this subjectThe efficacy of F2F CPT for aphasia is well established. Online delivery of CPT programs may offer more cost‐effective and accessible services when compared with F2F approaches; however, there is a need to explore the efficacy of online programs.What this paper adds to existing knowledgeThe 45‐min online aphasia CPT program was found to be efficacious for improving student healthcare professionals' knowledge and attitudes towards aphasia and communication, and produced equally successful outcomes when compared with F2F delivery. This is the first study to report the efficacy of an online CPT program that is aligned with SCA for use with student healthcare professionals that also uses a self‐report outcome measure with validated psychometric properties.What are the potential or actual clinical implications of this work?Online CPT programs may be useful in both clinical and education contexts to support improved efficiency of services and to enhance communication environments for people with aphasia in healthcare contexts. [ABSTRACT FROM AUTHOR]

Background: Anxiety is a common symptom in patients with the Acute Coronary Syndrome (ACS), which can threaten their quality of life. This study was done to compare the effects of aromatherapy using lavender and Benson's relaxation technique on the anxiety of patients with ACS. Methods: In this randomized clinical trial, 96 patients with ACS were selected using consecutive sampling method from two hospitals in an urban area of Iran. The patients were randomly assigned to three groups of aromatherapy (n=32), Benson's relaxation (n=32), and control (n=32) using the block size of six. The interventions were performed on two consecutive days, once a day for 20 min. Anxiety was measured before and immediately after the intervention using the Spielberger's Anxiety Inventory. Data were analyzed using the Chi-square test, Fisher's exact test, one-way Analysis Of Variance (ANOVA), Bonferroni post hoc test, and mixed-model repeated-measures ANOVA with a 3*2*2 design by the SPSS V. 16. Results: There was no statistically significant difference in state and trait anxiety scores between the groups after the intervention on different time points (P> 0.05). The time (P=0.001), group-day interaction (P=0.005), and time (pretest and posttest) and day (P=0.029) effect on state anxiety was statistically significant. The time (P<0.001) and the group-day interaction (P<0.001) effect on trait anxiety was statistically significant. Conclusion: Benson's relaxation method and lavender aromatherapy did not significantly reduce anxiety in patients with ACS. Considering the anxiety and its complications in patients with ACS and the importance of its management, further studies are needed to determine appropriate care and treatment for these patients and reduce their anxiety. [ABSTRACT FROM AUTHOR]

This 6-month pilot randomized controlled trial examined the effectiveness of a Mobile Health (mHealth) intervention for hypertension self-monitoring and management in an underserved urban community. The four health outcomes measured included changes in systolic and diastolic blood pressure (BP), BP monitoring adherence, perceived medication adherence self-efficacy, and health-related quality of life. Thirty participants were randomly assigned to the mHealth group or a standard follow-up group; 25 participants completed the study. The mHealth group had statistically significant improvement in systolic BP decrease (p =.01). The mHealth group had better adherence to BP monitoring and improved perceived medication adherence self-efficacy at 6 months, compared with the standard follow-up group. The results suggest that an mHealth intervention has the potential to facilitate hypertension management in underserved urban communities. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the impact of the specially designed medical dressing screen during wound dressing changes for children aged 1–3 who experienced a burn on their hand or foot. Design: Randomized controlled trial. Methods: The study was performed, between January 2019 ‐ April 2019, at a Burn Outpatient Ward. A total of 52 outpatient children who had suffered burns were included in the clinical trial. The burn area of these participants accounted for 1–5% of the total body surface area. The children were randomly divided into two equal‐sized groups, each receiving a different treatment. In the medical screen group (N = 26), a medical screen was used for children during the dressing changes. In the control group (N = 26), the children received only regular dressing changes. Pain level of the children during dressing change was the primary outcome, the satisfaction of children's parents and wound therapist were used as second outcomes. The Bonferroni method was used to perform pairwise comparisons of repeatedly measured data at different measurement times in two groups. Results: The results showed that the medical screen group had better outcomes with respect to pain management during dressing changes; in addition, the satisfaction score of the wound therapist and children's parents presented also better outcomes compared with the control group. Conclusion: This study demonstrated application of the medical screen for burns can relieve the pain of 1 ‐ 3‐year old children experienced a burn during dressing changes. In addition, the application of the medical screen also increased the satisfaction of the child's parents and wound therapist. Registration NO: 1,900,020,953. Impact: Compared with conventional dressing methods, the medical screen can be used as a novel way to decrease the negative experience of burn patients ages 1–3 who require dressing changes. [ABSTRACT FROM AUTHOR]

Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result. [ABSTRACT FROM AUTHOR]

Objective: To assess if a higher dose of exercise training in exercise-based cardiac rehabilitation could affect improvements in aerobic capacity and muscle strength. Design: Assessor-blinded randomized controlled trial with 12-months follow-up. Setting: Aarhus University Hospital, Aarhus, Denmark. Subjects: A total of 164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited. Interventions: Patients were randomized to 1-hour exercise sessions either three times weekly for 12 weeks (36 sessions, high-dose group) or twice weekly for 8 weeks (16 sessions, low-dose group). The same standardized exercise and intensity protocol including aerobic and muscle strength training was used in all participants. Main measures: Primary outcome was changes in VO2peak. Secondary outcomes were changes in maximal workload, muscle strength and power. Measures were obtained at baseline, after termination of the rehabilitation programme and at follow-up after 6 and 12 months. Results: After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO2peak 2.6 (mL kg−1 min−1) (95% confidence interval (CI): 0.4–4.8), maximal workload 0.3 W kg−1 (95%CI: 0.02–0.5), isometric muscle strength 0.7 N m kg−1 (95%CI: 0.1–1.2) and muscle power 0.3 W kg−1 (95%CI: 0.04–0.6). After 12 months, a significant between-group difference only persisted in VO2peak and maximal workload. Conclusion: A higher dose of exercise training had a small effect on all outcomes at termination of intervention. A long-term effect persisted in VO2peak and maximal workload. Although the effect was small, it is an important finding because VO2peak is the most important predictor of all-cause mortality in cardiac patients. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of an educational intervention including "face to face" training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific "face-to-face" interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant (P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials. [ABSTRACT FROM AUTHOR]

Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registrationhttps://Clinicaltrials.gov/: NCT02396797. Registered March 23th, 2015. [ABSTRACT FROM AUTHOR]

Rationale, aims, and objectives: The potential bias introduced by surgeons' lack of comparable, relevant experience when performing the procedures in different arms of randomized controlled trials (RCTs) is arguably not well‐managed or reported. The aim of this work was to review the frequency and nature with which surgeons' relevant experience is reported in RCTs of total hip (THA) and total knee arthroplasty (TKA), and to relate this to other risk of bias domains for this study design. Methods: A systematic review of RCTs comparing different minimally invasive procedures for TKA and comparisons of THA and hemiarthroplasty (HA). We searched MEDLINE, EMBASE, Science Citation Index, The Cochrane Library, Conference Proceedings Citation Index‐Science (CPCI‐S), Current Controlled Trials, and Clinical Trials.gov. Results: Seventy‐five relevant RCTs were identified, 65 RCTs comparing minimally invasive with standard or other minimally invasive approaches to TKA, and 10 for THA compared with HA. Risk of bias based on the reported details of surgeons' relevant experience was categorized as low, high, or unclear. There was a clear distinction before and after 2009, with a substantial decrease in trials at high or unclear risk of bias after this date. There were no strong associations between this domain and other, standard risk of bias domains for RCTs. Conclusion: The surgeons' relevant experience in an evaluated procedure is often poorly reported but has improved since 2009. The variable is not adequately captured by any other risk of bias domain. Future work should concentrate on conducting research on a much larger sample of studies and in procedures other than knee and hip arthroplasty. [ABSTRACT FROM AUTHOR]

Purpose: This research study aims to evaluate the effectiveness of a psychoeducation group, which is founded on an Eastern approach to health care, in improving the quality of life of Chinese people with mild cognitive impairment (PwMCI). Method: In a randomized controlled trial (RCT), 40 Chinese PwMCI were randomly assigned to either a 10-session psychoeducation group or the control group. Results: A paired sample t test indicated that the treatment group (n = 18) showed significant improvement in their World Health Organization Quality of Life Measure (WHOQOL) score, while the control group (n = 22) did not. Moreover, an independent t test showed that the treatment group was more effective than the control group to improve their WHOQOL score. A reduction in the depressive symptoms was related to the improvement in WHOQOL score. Conclusions: This RCT provides evidence to support the feasibility and effectiveness of psychoeducation groups for improving the overall quality of life of PwMCI. [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Little is known about the effects of distraction techniques when undertaking medical procedures with hospitalized pediatric patients in Asian countries. This study examined the effects of distraction interventions on behavioral distress related to venipuncture procedures in Taiwanese children aged 3 to 7 years. Using concealed randomization, eligible children were allocated to receive a picture book (n = 92), or animated cartoon (n = 92) compared with routine oral instructions (n = 92), when being injected with an intravenous cannula. Two trained observers independently scored the responses of each child using the Observational Scale of Behavioral Distress–Revised before, during, and after the procedure. All children experienced distress during needle insertion, but distress was less in the distraction-based intervention groups. Moreover, distraction interventions were more effective for children aged 4 to 5 years. Our culturally tailored intervention engaged child participants, was age-appropriate, and could be adapted for use in other Chinese cultures. [ABSTRACT FROM AUTHOR]

Strengthening the positive aspects of caregiving for dementia caregivers is necessary to minimize their burden. This Thai study examined the effectiveness of a program for enhancing positive aspects of caregiving and subjective well-being among caregivers of older persons with dementia. Seventy two participants were randomly assigned equally into experimental and control groups. The experimental group received the Program for Enhancing the Positive Aspects of Caregiving while the control group received usual care. The experimental program consisted of caregiving self-efficacy enhancement, exploring spirituality, and increasing perceived social support. Data were collected using the Positive Aspects of Caregiving Questionnaire and the Thai General Well-being Schedule and analyzed using descriptive statistics, and the one-way and two-way repeated measure ANOVA. Results showed that the program could significantly increase positive aspects of caregiving among the caregivers at 8, 12 and 20 weeks after program implementation. The program could also significantly increase the subjective well-being of the experimental group at all points of measurement. Results of this study suggest that nurses can apply this program to enhance positive aspects of caregiving and subjective well-being for caregivers of older persons with dementia, however further testing of the program is required. [ABSTRACT FROM AUTHOR]

Background: Corticosteroid injection is a common treatment for frozen shoulder, but controversy still exists regarding the injection site with the best outcome. Hypothesis: To treat the frozen shoulder in the freezing stage with corticosteroid injection, a single injection into the rotator interval (RI) could yield better effects in terms of improvement in pain, passive range of motion (ROM), and function than would an injection into the intra-articular (IA) or subacromial (SA) space. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients with primary frozen shoulder in the freezing stage were randomized into 3 groups: RI injection, IA injection, or SA injection with corticosteroid. Clinical outcomes were documented at baseline and at 4, 8, and 12 weeks after intervention, including visual analog scale (VAS) for pain; passive ROM measurements, including external rotation, internal rotation, forward flexion, and abduction; and evaluation with the Disability of Arm, Hand, and Shoulder (DASH) score and Constant score. Results: There were no significant differences in the basic properties of the 3 groups (27 in RI group, 24 in IA group, and 26 in SA group) before injection. Improvements in pain VAS, passive ROM, Constant score, and DASH score were faster and significant in the RI group from 4 weeks after injection, followed by those in the IA group. Passive ROM decreased and DASH score did not change significantly in the SA group, although pain VAS and Constant score improved significantly. Conclusion: To treat frozen shoulder in the freezing stage with corticosteroid injection, a single injection into the RI yielded better effects in terms of improvement in pain, passive ROM, and function than did injections into the IA or SA space. [ABSTRACT FROM AUTHOR]

Abstract: Background and purpose: Pneumonia is the most important respiratory problem in low‐to‐middle income countries. Airway clearance therapy continues to be used in children with pneumonia and secretion retention; however, there is lack of evidence to support or reject this treatment. This study aimed to investigate the feasibility of a randomized controlled trial (RCT) on the efficacy and safety of assisted autogenic drainage (AAD) compared to standard nursing care in children hospitalized with uncomplicated pneumonia. Methods: A single‐blinded pilot RCT was conducted on 29 children (median age 3.5 months, IQR 1.5–9.4) hospitalized with uncomplicated pneumonia. The intervention group received standard nursing care with additional bi‐daily AAD, for 10 to 30 min. The control group only received standard nursing care, unless otherwise deemed necessary by the physician or physiotherapist. The primary outcome measure was duration of hospitalization. The secondary outcome measures included days of fever and supplemental oxygen support; respiratory rate (RR) and heart rate adjusted for age; RR and oxygen saturation pre‐, post‐, and 1‐hr post‐treatment; oxygen saturation; adverse events; and mortality. Results: No difference was found for duration of hospitalization (median 7.5 and 7.0 days for the control and intervention groups, respectively); however, Kaplan–Meier analysis revealed a strong tendency towards a shorter time to discharge in the intervention group (p = .06). No significant differences were found for the other outcome measures at time of discharge. No adverse events were reported. Within the intervention group, a significant reduction in RR adjusted for age was found. Discussion: As no adverse events were reported, and AAD did not prolong hospitalization; AAD might be considered as safe and effective in young children with uncomplicated pneumonia. However, a larger multicentred RCT is warranted to determine the efficacy of AAD compared to standard nursing care. [ABSTRACT FROM AUTHOR]

Depression is a mental health problem worldwide, often a co-occurring condition with disabilities and contributes to a low quality of life and suicide. Older women are more likely to experience depression than older men and need specific interventions to reduce their depressive symptoms. This randomized controlled trial examined the effect of a group administered cognitive behavior therapy program for reducing depressive symptoms among older women. Sixty Thai older women living in the community, who met the inclusion criteria and presented at primary care units in Northern Thailand, were randomly assigned into either a group undertaking a cognitive behavior therapy program (n=30) or a usual care control condition (n=30). Depression was measured using the Patient Health Questionnaire-9, Thai version at baseline, immediately after the time needed to complete The Thai Group CBT Intervention Program, and then at 1 and 3 months follow-up. Repeated measures analysis of variance (ANOVA) and independent sample t-test were used to test the program efficacy. Results indicated that the mean depression scores in the CBT condition at every point were significantly lower than at baseline and also statistically lower than those of the usual care condition after completing the program. Thus, The Thai Group CBT Intervention Program was found to be efficacious in reducing depression. Nurses should consider integrating this intervention for older persons with depression into primary care; however, further study is needed to demonstrate the durability of the depression reduction effects. [ABSTRACT FROM AUTHOR]

Objectives Diabetes mellitus and periodontal disease are highly prevalent among Indigenous Australian adults. Untreated periodontitis impacts glycaemic control in people with diabetes. The aim of this study was to report on the effect of periodontal therapy on glycaemic control among people with obesity. Methods This subgroup analysis is limited to 62 participants with diabetes from the original 273 Aboriginal Australian adults enrolled into the PerioCardio study. Intervention participants received full-mouth non-surgical periodontal scaling during a single, untimed session while controls were untreated. Endpoints of interest included change in glycated haemoglobin (HbA1c), C-reactive protein ( CRP) and periodontal status at 3 months post-intervention. Results There were more females randomized to the treatment group ( n = 17) than control ( n = 10) while the control group had a higher overall body mass index ( BMI) [mean ( SD)] 33.1 (9.7 kg m−2) versus 29.9 (6.0 kg m−2). A greater proportion of males were followed up at 3 months compared to females, P = 0.05. Periodontal therapy did not significantly reduce HbA1c: ancova difference in means 0.22 mmol mol−1 (95% CI −6.25 to 6.69), CRP: ancova difference in means 0.64 (95% CI −1.08, 2.37) or periodontal status at 3 months. Conclusions Non-surgical periodontal therapy did not significantly reduce glycated haemoglobin in participants with type 2 diabetes. Reasons are likely to be multifactorial and may be influenced by persistent periodontal inflammation at the follow-up appointments. Alternatively, the BMI of study participants may impact glycaemic control via alternative mechanisms involving the interplay between inflammation and adiposity meaning HbA1c may not be amenable to periodontal therapy in these individuals. [ABSTRACT FROM AUTHOR]

This study was conducted to determine and compare the effectiveness of nature sounds and relaxation exercises for reducing preoperative anxiety. A repeated measures randomized controlled trial design was used. We divided 159 preoperative patients into three groups: nature sounds ( n = 53), relaxation exercises ( n = 53), and control groups ( n = 53). We evaluated anxiety using the visual analog scale and state anxiety inventory scores immediately before, immediately after, and 30 min after interventions in nature sounds and relaxation exercises groups, and silent rest in the control. We found no differences between the measurement values in the intervention groups, but we did observe a difference between the intervention and control groups. The two interventions were similarly effective in reducing preoperative anxiety. These simple and low-cost interventions can be used to reduce preoperative anxiety in surgical clinics. [ABSTRACT FROM AUTHOR]

Background: Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Methods: Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. Results: A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Conclusions: Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. Trial registration: ClinicalTrials.gov Identifier: NCT00713843. [ABSTRACT FROM AUTHOR]

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013–2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge. [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the ability of two concurrent randomized controlled interventions based on social cognitive theory to increase walking. A second purpose was to compare the efficacy of the intervention between two distinct groups: dog owners and non-dog owners. Adult dog owners (n = 40) and non-dog owners (n = 65) were randomized into control or intervention groups. Intervention groups received bi-weekly emails for first 4 weeks and then weekly email for the next 8 weeks targeting self-efficacy, social support, goal setting, and benefits/barriers to walking. Dog owner messages focused on dog walking while non-dog owners received general walking messages. Control groups received a 1-time email reviewing current physical activity guidelines. At 6 months, both intervention groups reported greater increases in walking and maintained these increases at 12 months. The greatest increases were seen in the dog owner intervention group. In conclusion, dog owners accumulated more walking, which may be attributed to the dog-owner relationship. [ABSTRACT FROM AUTHOR]

Background: Currently, feasible medical treatments are hitherto not satisfying to relieve pSS symptoms, which concerns numbers of clinical doctors. Acupuncture seems to be an alternative to treat pSS and conduces to good symptomatic results. However further research is necessary. This trial is to investigate the efficacy of acupuncture on improving the key symptoms of pSS, which are dryness, pain and fatigue (DPF). Methods & Design: The study is designed as a randomized controlled trial of two arms with a single centre. We compare acupuncture with sham acupuncture on symptomatic improvements of pSS. A total of 120 pSS patients, aged at least 18, with DPF, will be randomly assigned to acupuncture or sham acupuncture groups, where they will have needle intervention for 8 weeks with 16 weeks of follow-up. Subjects will be assessed each time before interventions during the 8-week intervention, in week 8 after all interventions and in week 12, 16, 20 and 24 for follow-up with different measurements. The primary outcome are the proportions of subjects that have 30% or greater reduction in at least 2 out of 3 items of DPF in Numeric Analog Scale (NAS) scores (0 = the best, 10 = the severest), calculated between the baseline and the average scores of week 2 to 8. The secondary outcome are related to individual items of NAS scores, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), Schirmer test score and unstimulated salivary flow, serum Immunoglobulin G, A and M levels, Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36), Salivary glands ultrasounds, Hospital Anxiety and Depression (HAD) scale score. The secondary outcome scores are to be collected at baseline, in week 8, 16, and 24. Besides, individual items of NAS will also be collected in week 12 and 20. Moreover, subjects' satisfaction and the proportion of the subjects who identified their allocation will also be measured and analyzed. Discussion: This study will be the first randomized and controlled pilot trial of acupuncture on alleviating the symptoms of pSS with relatively long-term follow-up. The result of the study might offer a new option to treat pSS and might be a clinical proof that acupuncture has beneficial effects on pSS. Trial registration: ClinicalTrials.gov: NCT02691377 (February 20, 2016) [ABSTRACT FROM AUTHOR]

Background: Impaired emotional well-being has detrimental effects on health outcomes in patients with chronic heart failure (CHF). Aims: To evaluate a nurse-led Coping Effectiveness Training (CET) group intervention for patients with CHF. It was hypothesized that CET would increase emotional well-being (primary outcome) and health-related quality (HRQoL) of life and improve clinical outcomes. Furthermore, changes in appraisal and coping as mediators of the intervention effect were examined. Methods: Participants were randomized to either control group (n=51) receiving standard health care or CET intervention group (n=52). Self-assessments of positive affect, negative affect, depression, anxiety, HRQoL, illness perception, coping strategies and social support were performed pre- and post-intervention and after six weeks, six months and 12 months. Time to death and hospitalizations were measured during the entire follow-up (median 35 months, interquartile range 11 months). Results: No significant improvements for emotional well-being and HRQoL in the intervention group compared with the control group were found. After excluding patients with clinical anxiety and depression at baseline the intervention group had significantly lower negative affect (p = 0.022). There were no significant differences regarding cardiovascular events between the groups. The intervention group had greater sense of control over their illness in the short-term (p = 0.036). Conclusion: CET intervention was found to increase sense of control over the illness in the short term. Psychosocial support programmes, like CET, for patients with CHF is currently lacking evidence for implementing in clinical practice. However, the results provide a basis for future studies with a modified CET intervention design and increased study size. [ABSTRACT FROM AUTHOR]

We conducted a randomized, controlled trial to examine the effects of a salt-reduction and efficacy-maintenance program on the improvement and maintenance of self-care and self-efficacy in reducing the salt intake of older people with high blood pressure. A total of 51 participants with hypertension/prehypertension in Indonesia were randomly assigned to a control group or one of two intervention groups: salt-reduction training or salt-reduction and efficacy-maintenance. The salt-reduction and efficacy-maintenance group received educational training and a maintenance meeting; the participants' knowledge, attitudes, self-care practices, and self-efficacy significantly improved after training and were maintained after the maintenance meeting. Participants in the salt-reduction training group showed significant effects for the same variables; however, their food salt concentrations rebounded after the maintenance meeting. No significant improvement was found in the control group. The salt-reduction and efficacy-maintenance group participants reported positive effects of salt reduction and different practices based on who prepared their meals. The salt-reduction and efficacy-maintenance group program was effective in improving and maintaining knowledge, attitudes, and self-efficacy of salt-reduction practices and could be applied with community-dwelling older people with high blood pressure. [ABSTRACT FROM AUTHOR]

Background: Green tea has been suggested to improve cardiovascular disease risk factors, including circulating lipid variables. However, current evidence is predominantly based on small, short-term randomized controlled trials conducted in diverse populations. Objective: The aim of this study was to examine the efficacy and impact of green tea extract (GTE) supplementation high in epigallocatechin gallate (EGCG) on blood lipids in healthy postmenopausal women. Design: This was an ancillary study of a double-blind, randomized, placebo-controlled, parallel-arm trial investigating the effects of a GTE supplement containing 1315 mg catechins (843 mg EGCG) on biomarkers of breast cancer risk. Participants were randomly assigned to receive GTE (n = 538) or placebo (n = 537) and were stratified by catechol-O-methyltransferase (COMT) genotype activity (high COMT compared with low or intermediate COMT genotype activity). They consumed either 4 GTE or identical placebo capsules daily for 12 mo. A total of 936 women completed this substudy. Circulating lipid panels including total cholesterol (TC), HDL cholesterol, and triglycerides were measured at baseline and at months 6 and 12. Results: Compared with placebo, 1-y supplementation with GTE capsules resulted in a significant reduction in circulating TC (-2.1% compared with 0.7%; P = 0.0004), LDL cholesterol (-4.1% compared with 0.9%; P < 0.0001) and non-HDL cholesterol (-3.1% compared with 0.4%; P = 0.0032). There was no change in HDL-cholesterol concentration, but triglyceride concentrations increased by 3.6% in the GTE group, whereas they decreased by 2.5% in the placebo group (P = 0.046). A significant reduction in TC was observed only among women with high (i.e., ≥200 mg/dL) baseline TC concentrations (P-interaction = 0.01) who consumed GTE capsules. The effect of GTE on the increase in triglycerides was mainly observed among obese women and statin users (P-interaction = 0.06). Conclusion: Supplementation with GTE significantly reduced circulating TC and LDL-cholesterol concentrations, especially in those with elevated baseline TC concentrations. This trial was registered at clinicaltrials.gov as NCT00917735. [ABSTRACT FROM AUTHOR]

We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention ( n = 60) or control ( n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. [ABSTRACT FROM AUTHOR]

Objective To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment. Background Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments. Methods One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minutes). Subanalyses of episodic cluster headache (eCH) and chronic cluster headache (cCH) cohorts were prespecified. Results The intent-to-treat population comprised 133 subjects: 60 nVNS-treated (eCH, n = 38; cCH, n = 22) and 73 sham-treated (eCH, n = 47; cCH, n = 26). A response was achieved in 26.7% of nVNS-treated subjects and 15.1% of sham-treated subjects ( P = .1). Response rates were significantly higher with nVNS than with sham for the eCH cohort (nVNS, 34.2%; sham, 10.6%; P = .008) but not the cCH cohort (nVNS, 13.6%; sham, 23.1%; P = .48). Sustained response rates were significantly higher with nVNS for the eCH cohort ( P = .008) and total population ( P = .04). Adverse device effects (ADEs) were reported by 35/150 (nVNS, 11; sham, 24) subjects in the double-blind phase and 18/128 subjects in the open-label phase. No serious ADEs occurred. Conclusions In one of the largest randomized sham-controlled studies for acute CH treatment, the response rate was not significantly different (vs sham) for the total population; nVNS provided significant, clinically meaningful, rapid, and sustained benefits for eCH but not for cCH, which affected results in the total population. This safe and well-tolerated treatment represents a novel and promising option for eCH. identifier: NCT01792817. [ABSTRACT FROM AUTHOR]

Introduction. Colorectal cancer (CRC) and its treatments can cause distressing sequelae. We conducted a multicenter randomized controlled trial aiming to improve psychological distress, supportive care needs (SCNs), and quality of life (QOL) of patients with CRC. The intervention, called SurvivorCare (SC), comprised educational materials, needs assessment, survivorship care plan, end-of-treatment session, and three follow-up telephone calls. Methods. At the end of treatment for stage I-III CRC, eligible patients were randomized 1:1 to usual care (UC) or to UC plus SC. Distress (Brief Symptom Inventory 18), SCNs (Cancer Survivors' Unmet Needs measure), and QOL (European Organization for Research and Treatment of Cancer [EORTC] QOL questionnaires C30 and EORTC CRC module CR29) were assessed at baseline and at 2 and 6 months (follow-up 1 [FU1] and FU2, respectively). The primary hypothesis was that SC would have a beneficial effect on distress at FU1. The secondary hypotheses were that SC would have a beneficial effect on (a) SCN and QOL at FU1 and on (b) distress, SCNs, and QOL at FU2. A total of 15 items assessed experience of care. Results. Of 221 patients randomly assigned, 4 were ineligible for the study and 1 was lost to FU, leaving 110 in the UC group and 106 in the SC group. Patients' characteristics included the following: median age, 64 years; men, 52%; colon cancer, 56%; rectal cancer, 35%; overlapping sites of disease, 10%; stage I disease, 7%; stage II, 22%; stage III, 71%. Baseline distress and QOL scores were similar to population norms. Between-group differences in distress at FU1 (primary outcome) and at FU2, and SCNs and QOLat FU1 and FU2 were small and nonsignificant. Patients in the SC group were more satisfied with survivorship care than those in the UC group (significant differences on 10 of 15 items). Conclusion. The addition of SC to UC did not have a beneficial effect on distress, SCNs, or QOL outcomes, but patients in the SC group were more satisfied with care. [ABSTRACT FROM AUTHOR]

Aim To assess the effectiveness of a decision support intervention using a pragmatic single blind Randomized Controlled Trial. Background Worldwide the proportion of older people (aged 65 years and over) is rising. This population is known to have a higher prevalence of chronic diseases including chronic kidney disease. The resultant effect of the changing health landscape is seen in the increase in older patients (aged ≥65 years) commencing on dialysis. Emerging evidence suggests that for some older patients dialysis may provide minimal benefit. In a majority of renal units non-dialysis management is offered as an alternative to undertaking dialysis. Research regarding decision-making support that is required to assist this population in choosing between dialysis or non-dialysis management is limited. Design A multisite single blinded pragmatic randomized controlled trial is proposed. Methods Patients will be recruited from four Queensland public hospitals and randomizd into either the control or intervention group. The decision support intervention is multimodal and includes counselling provided by a trained nurse. The comparator is standard decision-making support. The primary outcomes are decisional regret and decisional conflict. Secondary outcomes are improved knowledge and quality of life. Ethics approval obtained November 2014. Conclusion This is one of the first randomized controlled trials assessing a decision support intervention in older people with advance chronic kidney disease. The results may provide guidance for clinicians in future approaches to assist this population in decision-making to ensure reduced decisional regret and decisional conflict. [ABSTRACT FROM AUTHOR]