Participants In Intervention Group Research Articles

The Implementation of the Advocacy Intervention for Midlife and Older Women Who Have Experienced Intimate Partner Violence: Protocol for a Randomized Controlled Trial.

Midlife and older women who experience intimate partner violence (IPV) often have less access to supports and services than younger women. There is far less focus on research and supports for midlife and older women compared to younger women experiencing IPV, and often, neither elder abuse nor IPV services meet their needs. Few interventions are available to meet the needs of midlife and older women. The goal of this randomized controlled trial is to test the effectiveness of an advocacy intervention for midlife and older women who experience IPV and to learn from the experiences of those who implement and participate in the program. This trial is a 2-arm, unblinded, parallel, pragmatic randomized controlled trial with a qualitative component. Eligible participants will be women who live in the Maritime provinces of Canada (New Brunswick, Nova Scotia, and Prince Edward Island), who are in midlife and older (aged approximately ≥50 years), and who are currently in a relationship with an abusive partner or have recently left an abusive partner. Facilitators will be trained to deliver the intervention. The intervention will be entirely virtual and will consist of 2 components: (1) an empowerment component, which will involve sharing resources and information with the women; and (2) a social support component, which will include providing support and encouragement to women for 12 weeks. Quantitative effectiveness data will be collected from all trial participants at baseline, 3 months after the intervention, and 9 months after the intervention about the incidence and severity of IPV, physical and mental health, and safety behaviors and strategies. Qualitative interviews will be conducted with the facilitators and intervention group participants. Control group participants will receive a static, nontailored version of the advocacy intervention for midlife and older women (AIM) intervention materials after baseline data collection. A total of 12 facilitators have been trained to deliver the AIM intervention to trial participants. Participant recruitment and data collection will be completed in January 2025. Data analysis will continue throughout the data collection period, and the results will be disseminated by December 2025. This research will result in the adaptation and testing of a program to support and empower midlife and older women in the Maritime provinces of Canada who experience IPV. International Standard Randomized Controlled Trial Registry ISRCTN30646991; https://doi.org/10.1186/ISRCTN30646991. DERR1-10.2196/57886.

An online grief intervention to improve well-being and reduce clinical symptoms: a randomized controlled trial

The COVID-19 pandemic amplified the emotional impact of losing a loved one, deteriorating well-being, and increasing dysphoric symptoms in mourners. This study evaluated the efficacy of COVID Grief, a self-applied online cognitive-behavioral intervention for Mexican adults facing grief during the pandemic. We conducted a randomized clinical trial, enrolling 1,109 participants, 45 of whom completed the full intervention, and 69 of whom completed the waiting list control (WLC). Between-subject analysis showed that intervention group (IG) participants reported significantly higher satisfaction with life and quality of life and a reduction in depression, anxiety and stress levels compared to those in the WLC. Within-subjects analysis showed that IG presented no significant changes in satisfaction with life, whereas the quality of life was increased, and levels of depression, anxiety, and stress were reduced after treatment. For WLC, satisfaction with life and quality of life were significantly decreased, and symptoms of depression and anxiety -but not stress symptoms- increased after the waitlist. Completer’s opinions of the treatment were highly positive, although they only represent 5% of participants who accessed the intervention. High dropout rates should be addressed in future studies.

The Effect of a Biofeedback-Based Integrated Intervention for Older Adults with Orthostatic Hypotension: A Secondary Analysis on Psychological Health Outcomes in a Non-Randomized Pilot Trial

Background/Objectives: Aging-related physical changes and dysfunctions in the autonomic nervous system (ANS) often lead to orthostatic hypotension (OH) in older adults. OH negatively impacts both the physical and psychological well-being of those affected. Previous studies have demonstrated that the biofeedback-based integrated program (BBIP), a multicomponent intervention focused on heart rate variability biofeedback, effectively improves OH, as well as symptoms related to ANS function. This substudy aims to examine the effects of the BBIP on psychological health outcomes among community-dwelling older adults with OH. Methods: This study employed a non-randomized controlled trial design with a convenience sampling strategy. A total of 51 older adults with OH were recruited from two senior welfare centers and randomly assigned to either the intervention group (n = 27) or the control group (n = 24). The intervention group participated in a 12-week BBIP, which included weekly biofeedback sessions and group education on lifestyle modification to alleviate OH. Telephone counseling was also provided to promote compliance. Results: The intervention group showed significant improvements in health-related quality of life, depression, anxiety, and fall efficacy after the 12-week BBIP, whereas the control group exhibited no significant changes. There was a significant reduction in the percentage of participants in the intervention group reporting problems in all five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Conclusions: The BBIP was effective in improving the psychological health outcomes of older adults with OH. Future studies should explore the long-term effects of the BBIP using a larger sample size and a randomized controlled trial design.

Using a Fluorescent Concretization Intervention Improves Hand Hygiene Training in Primary School Students: A Randomized Controlled Study

Introduction: Inadequate hand hygiene increases the rates of childhood infectious diseases and deaths, leading to the death of one child per minute. Aim: To examine the effects of an educational strategy, “using a fluorescent concretization intervention,” on the hand-washing skills of primary school students. Method: This single-center randomized controlled trial using a pretest and posttest design was conducted with 35 intervention and 35 control participants. Data were collected with Dermalux Test Lotion containing fluorescently detectable under ultraviolet light, Hand Washing Skill Checklist, Hand Washing Skill Efficacy, and Hand Hygiene Assessment Question Form in School Children. Results: After the training for both hands, the intervention group participants created a difference in the effectiveness of hand washing from dirty to clean in all areas (p < 0.001). The scores regarding psychomotor skills and duration of hand washing increased in all participants. Total score percentage changes increased more in the intervention group participants when the first and final follow-ups were compared (p < 0.001). Hand washing skills and durations increased after hand washing training using the fluorescent concretization method. Conclusion: Visual concretization and explanation to the students increase handwashing effectiveness. For this reason, it is highly recommended that technological devices that provide such visual feedback be used in schoolchildren's education.

Estrogen Plus Progestin and Colorectal Cancer: Long-Term Findings From the Women's Health Initiative Randomized Clinical Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report long-term colorectal cancer findings from the Women's Health Initiative trial where 16,608 postmenopausal women with a uterus were randomly assigned to daily conjugated equine estrogen (CEE) 0.625 mg, plus medroxyprogesterone acetate (MPA) 2.5 mg, or placebo. When intervention ended after 5.6 years, although there were 44% fewer colorectal cancers in the intervention group (43 v 72, P = .003), the cancers were more commonly lymph node-positive (59.0% v 29.4%, P = .003). Now after cumulative 24-year follow-up, with 431 colorectal cancers, CEE plus MPA no longer influenced colorectal cancer incidence (215 [0.15, annualized rate %] v 216 [0.15], hazard ratio [HR], 0.95 [95% CI, 0.79 to 1.15]). Although not statistically significant, there were more colorectal cancer deaths with CEE plus MPA (87 [0.049] v 69 [0.041] deaths, HR, 1.20 [95% CI, 0.87 to 1.65], P = .26). Vaginal bleeding (54.1% v 5.2% at 6 months) and breast changes were more frequent in the intervention group. After adjusting for postrandomization vaginal bleeding and breast changes, bowel examinations were significantly delayed in intervention group participants (P = .005), potentially contributing to diagnostic delay. Taken together, the findings suggest no clinically meaningful benefit for about 5 years of CEE plus MPA use on colorectal cancer outcome.

Hypertonic Saline Nasal Rinse Intervention: Immunomodulatory Effects in Dairy Workers

ABSTRACT Objective Increased risk of occupational exposure to bioaerosols has long been recognized in livestock operations including dairy facilities. Spanning the inhalable fraction (0–100 μm), dairy bioaerosols comprise a wide variety of inflammatory components that deposit in the nasopharyngeal region. The resultant inflammatory response from bioaerosol exposure is likely driving the increased prevalence of respiratory disease observed in dairy workers. It is also thought the microbiome of the upper respiratory system may help mediate this inflammation. We investigated the viability of a low-cost hypertonic saline nasal rinse intervention in modulating inflammatory responses in bioaerosol exposed dairy workers and its impact on microbial diversity. Methods Pre- and post-shift nasal rinses were administered and collected alongside full shift inhalable personal breathing zone (PBZ) samples for each participant for up to 5 consecutive days. Treatment group participants (n = 23) received hypertonic saline rinses while control group participants (n = 22) received normotonic saline rinses. Particulate matter (PM) and endotoxin concentrations were quantified from PBZ samples using gravimetric and enzymatic analytical methods, respectively. Pre- and post-shift rinses were analyzed for pro- and anti-inflammatory markers and microbial diversity using a multiplex assay and 16S rRNA sequencing, respectively. Results PM and endotoxin concentrations were comparable between groups indicating similar exposures. Post-shift pro-inflammatory markers were significantly higher than pre-shift for IL-13 (p = .047), IL-1β (p < .001), IL-6 (p < .001), IL-8 (p < .001), and TNF-α (p = .024). There was no evidence of a difference in log concentrations between intervention group or day among any of the measured inflammatory markers. Anti-inflammatory IL-10 concentrations increased across the 5 sample days, independent of treatment group suggesting tonicity may not be driving the change. However, this result was not significant (p = .217). Nasal microbiome alpha (within sample) and beta (between sample) diversity metrics did not differ significantly between group or day demonstrating no adverse washout intervention effects. Conclusion This study provided encouraging results that warrant future research to further evaluate saline nasal rinses as a workplace intervention.

The Effectiveness of a Parent Empowerment Intervention for Caregivers of Children with Cystic Fibrosis: A Randomized Controlled Trial

ABSTRACT This paper focused on the effectiveness of a parent empowerment intervention based on nursing education (PEINE). This study examined whether the intervention improved the quality of life of children with cystic fibrosis (CF) and improved their caregivers learn about the disease and develop problem-solving and coping skills. This randomized-controlled trial used a pretest-posttest parallel-group research design. The sample consisted of 48 parents (caregivers) of children with CF. Participants were randomly assigned to an intervention (n = 24) and a control group (n = 24). The intervention group received PEINE and standard care and treatment for ten weeks. The control group received standard care and treatment. Data were collected using a Disease Information Survey (DIS), the Ways of Coping Inventory (WCI), the Problem-Solving Inventory (PSI), and the Cystic Fibrosis Questionnaire (CFQ-R). After the intervention, the intervention group DIS scores (d: 1,627 [CI: 0.934,2.305], had more correct answers than the control group. Nursing interventions were effective (p < .001). There was no significant difference in the mean pretest-posttest PSI scores (d: 0.378 [CI: −0.221-0.972], posttest WCI scores (d: 0.239 [CI:-0.356-0.831]) between the intervention and control groups (p>.05). There was a significant difference in the mean posttest CFQ-R scores between the intervention and control groups (d: 1.363 [CI: l.698, 2.015]);(p < .001). PEINE increased the intervention group participants develop disease-management skills. However, the increase in their PSI and WCI scores was statistically insignificant. PEINE also increased the quality of life of children with CF. Parents of children followed in pediatric pulmonary diseases participated in the study. Parents were informed during outpatient clinic visits. After the first meeting, the children and parents who voluntarily agreed to participate in the research were contacted by phone. The outpatient nurse assisted in communicating with children and parents.

12424 A Feasibility Trial Of A Co-created Digital Self-management Programme For Adults With Polycystic Ovary Syndrome (Hope PCOS)

Abstract Disclosure: C.A. Percy: None. A. Turner: None. L. Aphramor: None. D. Broom: None. C. Clark: None. F. Martin: None. P. Wark: None. Introduction: Polycystic ovary syndrome (PCOS) has significant impact on depression, anxiety, psychological wellbeing and health-related quality of life. We co-created a theory-led, evidence-based, 6-week, digital self-management and positive wellbeing intervention (Hope PCOS), delivered to UK adults. We tested the intervention’s potential to improve mental health and wellbeing outcomes and its acceptability and usability for adults living with PCOS. Methods: This was a mixed methods feasibility randomised controlled trial conducted online, with a pre-post, waitlist-controlled design. Primary outcomes were recruitment, completion (≥ 3 intervention sessions) and follow-up rates. At baseline, participants reported demographic information, PCOS symptoms, depression (Patient Health Questionnaire (PHQ-9)), anxiety ((Generalised Anxiety Disorder Assessment (GAD-7)), polycystic ovary syndrome health-related quality of life (PCOSQ-50), psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS) and self-efficacy (Self-Efficacy to Manage Chronic Disease Scale (SEMCD6)) before randomisation to an intervention group (IG) receiving the intervention immediately or a waitlist control group (CG) receiving the intervention 12 weeks later. PHQ-9, GAD-7, PCOSQ-50, WEMWBS and SEMDC6 were reassessed at 6 and 12 weeks. IG participants reported the usability of the digital intervention (system usability scale (SUS)) and acceptability via qualitative exit interviews. Results: Of 131 eligible, consented participants, 83% (N=109, age M=37.1, SD=8.6 years) completed baseline measures and were randomised to the IG (n=54) or the CG (n=55). Baseline clinical caseness was high for depression (n=77, 70.6%) and anxiety (n=78, 71.6 %). Twenty-one participants (39%) in the IG completed ≥3 intervention sessions. At 6-week follow-up, completion of secondary outcomes was n=32 (59%) for IG and n= 38 (69%) for CG; at 12 weeks, n=31 (57%) for IG and n= 38 (69%) for CG. Twelve IG participants took part in the exit interviews. Exploratory descriptive statistics suggest there were greater improvements in depression, anxiety, psychological wellbeing, self-efficacy and quality of life for the intervention group completers compared to the waitlist control group. SUS data and thematic analysis suggest the intervention was usable, acceptable, relevant and interesting. Participants reported experiences including feeling seen and valued, having the difficulties of lifestyle change acknowledged, and learning valuable lessons, particularly how to monitor and manage emotions, prioritise self-care and complete personal goals. Conclusions: This novel intervention was rated as usable and acceptable, with potential for improving mental health and wellbeing outcomes. More research is needed to identify for whom the intervention is beneficial and on implementation in practice. Presentation: 6/1/2024

A community health worker–led intervention to improve patient knowledge and receipt of precision medicine: Updated ALCANCE randomized clinical trial findings.

181 Background: Inequitable access to precision medicine limits its impact. To address disparities, we co-developed the Addressing Latinx Cancer Care Equity Study (NCT04843332), a multi-level intervention with community stakeholders. ALCANCE was designed for low-income and Latinx adults with cancer in rural Monterey County, California. We provided annual training for clinicians about testing guidelines and precision medicine disparities. Trained CHWs educated patients about precision medicine and encouraged them to raise the topic with their oncologist. We tested whether the intervention improved patient knowledge and receipt of precision medicine. Methods: Patients with newly diagnosed or recurrent cancer, age ≥ 18 years, able to consent in English or Spanish, and who self-identified as a racial and ethnic minority OR low-income status OR were insured by public or agricultural company insurance OR uninsured and receiving cancer care at Pacific Cancer Care, a rural community oncology practice in Monterey County, were randomized 1:1 to usual care (control group) or usual care augmented with the multi-level intervention for 12 months (intervention group). The primary outcome was whether the multilevel intervention could increase patient knowledge of precision medicine using a validated 6 question survey from time of enrollment (baseline) to 6-months post-enrollment between groups. A secondary outcome was receipt of precision medicine. CHWs and clinicians completed semi-structured interviews. Results: 110 participants were randomized; 70% (n = 67) reported Spanish as their primary language; 81% (n = 89) identified as Hispanic. Median age was 55 years (55.4 ± 14.3, mean± SD); majority had annual household incomes (USD) ≤ $34,999 (59.0%, n = 46); majority obtained a high school diploma/GED or less (67.3%, n = 74). Most had gastrointestinal (35.5%, n = 39) and breast (24.5%, n = 27) cancers and were diagnosed with stage 3 or 4 (64.5%, n = 71) disease. Precision medicine knowledge was low at baseline across both the control and intervention groups (23.5 ± 19.3 versus 23.0 ± 17.7, respectively). Intervention group participants had greater precision medicine knowledge at 6-months (39.2 ± 23.0) than control group participants (24.2 ± 20.0) with greater increase in knowledge overtime than control group participants (p &lt; 0.001). More intervention group participants (n=46, 79.3%) received precision medicine testing than control (n=34, 60.7%). Across both groups, 26 of those tested had an actionable mutation. Of those 26, 66.7% (n=6 of 9) in the control group and 94.1% (n=16 of 17) in the intervention group received targeted therapy (p=0.065). Interviews with the care team indicated the model was acceptable and has been sustained as part of usual care. Conclusions: CHW-facilitated interventions may reduce disparities in precision medicine cancer care. Clinical trial information: NCT04843332

Enhancing Latent Tuberculosis Infection Treatment Adherence with Mobile Health Intervention: A Quasi-Experimental Study

Introduction: While detecting active TB is central to public health efforts, modelling indicates that reducing latent TB through preventive therapy is crucial. Current regimens mitigate risk but are lengthy and have side effects, necessitating support for uninterrupted treatment. This paper presents the development and evaluation of a digital health platform designed to enhance adherence among LTBI patients. Methods: A Quasi-experimental study was conducted among LTBI patients in Delhi. A total of 163 participants were allocated to intervention (n=82) and control (n=81) groups. Participants were followed up for 6 months post recruitment. Effectiveness of mobile application was evaluated through quantitative tools. Results: Intervention group participants showed slightly higher treatment completion rates (65.91%), in comparison to participants in control group (63%). The analysis demonstrated no co-relation of gender, age, education and employment with treatment completion rates in intervention group. While text and video-based interventions have shown success, there remains a need for more user-centric digital health interventions in this area, given the limited number of studies to date. Conclusion: The mobile health applications can be useful for LTBI care. However, there is a need of involving users during development so that continued interest of users can be ensured.

A Parallel-Group, Randomized Trial Examining Impact of Colposcopy Results Delivery by a Nurse Liaison on Patient-Reported Outcomes and Adherence

ObjectivesCervical cancer is on the rise in Canada. Addressing patient anxiety and improving patient understanding of colposcopy and results may improve adherence. This randomized controlled trial examined the impact of colposcopy results delivery by a Nurse Liaison versus the referring primary care provider (PCP) on patient anxiety, and secondary outcomes including patient satisfaction, knowledge of diagnosis, and 9-month adherence to follow-up. MethodsPatients ≥18 years old presenting for initial appointment at the study colposcopy clinic were randomized 1:1 to an intervention group (Nurse Liaison) versus a control group (PCP). After receiving colposcopy results, participants completed online measures of anxiety (State-Trait Anxiety Inventory), health care satisfaction scales (Patient Satisfaction Questionnaire-18, Health Anxiety Inventory, Visit-Specific Satisfaction Questionnaire-9), self-reported colposcopy diagnosis, and demographics. Chart review at 9 months assessed adherence to recommended colposcopy follow-up. Groups were compared on continuous and categorical variables, controlling for diagnosis severity and trait anxiety. ResultsThe intervention group had significantly lower state anxiety with State-Trait Anxiety Inventory-state mean scores of 37.3 versus 40.7 in controls (P = 0.03). Intervention group participants were more likely to correctly report their diagnosis (84% vs. 66.3%, P = 0.003). Questionnaire responders were more likely to be in the intervention group and had a higher proportion of cervical intraepithelial neoplasia 2+ pathology. There were no differences in demographics, patient satisfaction, or adherence to follow-up between groups. ConclusionsDirect delivery of colposcopy results by a trained Nurse Liaison was associated with decreased patient anxiety around colposcopy results, and increased patient knowledge regarding diagnosis. This model may be considered to improve patient-centred care.

Resistance exercise snacks as a workplace health intervention

Introduction &amp; Purpose Although resistance training (RT) is essential to preserve musculoskeletal fitness and maintain a healthy, independent life into old age, only 10-30% of adults perform the recommended number of 2 RT per week, with women participating in even less RT (Bennie et al., 2016, 2018). As women have less skeletal muscle mass, experience an earlier strength loss, and a greater decline in muscle quality, RT appears especially beneficial for them (Doherty, 2001; Janssen et al., 2000). A novel approach to deal with common participation barriers (lack of time, limited access to equipment/facilities) are resistance exercise snacks (RES; Fyfe et al., 2022). Therefore, it was investigated whether RES is an efficient concept for the workplace health promotion (WHP) to facilitate RT in women and improve musculoskeletal fitness. Methods This pilot-study followed a prospective, controlled intervention design. Female employees with sedentary occupations doing RT on less than 2 days/week before study participation were included. Participants self-selected for intervention group (IG) or control group (CG). While the IG (N = 15, mean age 42.1 ± 11.1 years) completed 10 min of RES each working day for 12 weeks supervised by a trainer, the CG (N = 15, mean age 49.9 ± 9.7 years) maintained their habitual physical activity. Primary outcome was change in muscle mass (bioelectrical impedance analysis, SECA® mBCA515 scale). Secondary outcome was change in maximum isometric strength (Dr. WOLFF BackCheck® 617). Balance (Y-balance composite-score, Y-Balance test kit), cardiovascular fitness, (6-minute walking test), perceived health (minimum European health module), and general life satisfaction (general life satisfaction short scale) were assessed for exploratory purpose. Measurements were taken before and after the intervention. The difference in change between groups for muscle mass, strength, balance, and cardiovascular fitness was analyzed via mixed model ANOVA. For perceived health and general life satisfaction Wilcoxon test was applied to analyze within group changes. Results 12 participants of IG and 14 of CG completed the study. Muscle mass improved significantly more in the IG (+.42 kg ± .54) compared to the CG (-.16 kg ± .51) (p = .01, ⴄ²p = .24). Strength did not change significantly between groups. Nevertheless, there was a trend for greater improvements in the IG compared to the CG for trunk extension, trunk flexion, and upper body push but not upper body pull. Regarding exploratory endpoints, no significant changes were found. Discussion Findings of the present study support the notion that training with light loads (&lt; 30% of 1RM) effectively stimulate muscle protein synthesis if the intensity of effort is high. Higher training loads might be required to maximally recruit muscle fibers and induce optimal strength gains. For improvements in balance and cardiovascular fitness more specific training programs are required. Future studies should investigate what training stimuli are needed within RES (e.g., volume, load, frequency) to optimize improvements in musculoskeletal fitness and motivate participants in the long-term applying randomized controlled intervention designs. Conclusion RES is an efficient approach for the WHP to improve muscle mass in inactive women with sedentary occupations. References Bennie, J. A., Lee, D.-C., Khan, A., Wiesner, G. H., Bauman, A. E., Stamatakis, E., &amp; Biddle, S. J. H. (2018). Muscle-strengthening exercise among 397,423 U.S. adults: Prevalence, correlates, and associations with health conditions. American Journal of Preventive Medicine, 55(6), 864–874. https://doi.org/10.1016/j.amepre.2018.07.022 Bennie, J. A., Pedisic, Z., van Uffelen, J. G. Z., Charity, M. J., Harvey, J. T., Banting, L. K., Vergeer, I., Biddle, S. J. H., &amp; Eime, R. M. (2016). Pumping iron in Australia: Prevalence, trends and sociodemographic correlates of muscle strengthening activity participation from a national sample of 195,926 adults. PLoS ONE, 11(4), Article e0153225. https://doi.org/10.1371/journal.pone.0153225 Doherty, T. J. (2001). The influence of aging and sex on skeletal muscle mass and strength. Current Opinion in Clinical Nutrition &amp; Metabolic Care, 4(6), 503–508. Fyfe, J. J., Hamilton, D. L., &amp; Daly, R. M. (2022). Minimal-dose resistance training for improving muscle mass, strength, and function: A narrative review of current evidence and practical considerations. Sports Medicine, 52(3), 463–479. https://doi.org/10.1007/s40279-021-01605-8 Janssen, I., Heymsfield, S. B., Wang, Z., &amp; Ross, R. (2000). Skeletal muscle mass and distribution in 468 men and women aged 18–88 yr. Journal of Applied Physiology, 89(1), 81–88. https://doi.org/10.1152/jappl.2000.89.1.81

Efficacy and safety of antidepressants for pain in older adults: A systematic review and meta-analysis.

In many countries, pain is the most common indication for use of antidepressants in older adults. We reviewed the evidence from randomized controlled trials on the efficacy and safety of antidepressants, compared to all alternatives for pain in older adults (aged ≥65 years). Trials published from inception to 1 February 2024, were retrieved from 13 databases. Two independent reviewers extracted data on study and participant characteristics, primary efficacy (pain scores, converted to 0-100 scale) and harms. Estimates for efficacy were pooled using a random effects model and reported as difference in means and 95% CI. Quality of included trials was assessed using the Cochrane risk of bias tool. Fifteen studies (n = 1369 participants) met the inclusion criteria. The most frequently studied antidepressants were duloxetine and amitriptyline (6/15 studies each). Pain related to knee osteoarthritis was the most studied (6/15 studies). For knee osteoarthritis, antidepressants did not provide a statistically significant effect for the immediate term (0-2weeks), (-5.6, 95% confidence interval [CI]: -11.5 to 0.3), but duloxetine provided a statistically significant, albeit a very small effect in the intermediate term, (≥6weeks and <12 months), (-9.1, 95% CI: -11.8 to -6.4). Almost half (7/15) of the studies reported increased withdrawal of participants in the antidepressant treatment group vs. the comparator group due to adverse events. For most chronic painful conditions, the benefits and harms of antidepressant medicines are unclear. This evidence is predominantly from trials with sample sizes of <100, have disclosed industry ties and classified as having unclear or high risk of bias.

Unlocking knowledge: a meta-analysis assessing the efficacy of educational escape rooms in health sciences education.

Educational escape rooms within health sciences education are gaining traction as a unique and engaging game-based strategy for reviewing instructional content. Educational escape rooms cultivate valuable skills such as teamwork, communication, creativity, attention to detail, and the ability to apply knowledge under time pressures. While several studies have independently assessed learners' knowledge gains after educational escape room interventions, the present work meta-analyzes the efficacy of educational escape rooms across studies and student learners within health sciences education. A systematic search across seven databases was performed by a health sciences librarian from inception to March 24, 2023. Record screenings, full-text reviews, and data extractions were managed within Covidence. MERSQI criteria were used to assess study quality. Pooled effect sizes (Standardized Mean Differences = SMD) were estimated through meta-analysis to summarize learner performance outcomes after educational escape room interventions. Eleven studies followed a longitudinal pretest-posttest design, and five studies followed a control-treatment group design. Learners' posttest scores after participating in an educational escape room were statistically higher than their pretest scores as indicated by a large positive summary effect size (SMD ≥ 0.893; p <0.001). Educational escape rooms were also effective for treatment group participants (n = 508), who significantly outperformed (SMD = 0.616; p <0.001) control group participants (n = 555). Most escape rooms were employed as a mechanism for reviewing educational content. This meta-analytic review suggests escape rooms are effective educational interventions for increasing knowledge gains among health sciences learners and highlights common implementation practices to help guide educators interested in this game-based learning approach.

The Impact of Ankle Mobilization Techniques on Static Stability in Individuals With Acute Inversion Ankle Sprain: A Randomized Clinical Trial

ObjectiveThe purpose of the study was to compare the impact of the mobilization techniques and mobilization with movement techniques on static balance in individuals with acute inversion ankle sprain. MethodsVolunteers with acute inversion ankle sprain (N = 40) were equally and randomly assigned to 2 groups. Participants in intervention group I received the Mulligan mobilization with movement techniques, whereas participants in intervention group II underwent the Maitland mobilization techniques. Each participant received the intervention every other day for 2 consecutive weeks. To assess static balance, participants assumed a single-leg stance on the affected leg at the center of a force plate with eyes open or closed plate for 20 seconds. The displacement, velocity, and area of the center of pressure were recorded 1 day before and after the intervention. ResultsThe velocity of the center of pressure in the anterior-posterior direction was significantly reduced only in group I during eyes open (P = .043) and closed (P = .004). However, the displacement of the center of pressure in the anterior-posterior direction was significantly decreased in both group I (P = .024) and group II (P = .028) with eyes open. No significant changes were found in the area of the center of pressure in either group during eyes open or closed (P > .053). ConclusionsBoth Mulligan's and Maitland's approaches significantly improved sway displacement. For the individuals with acute inversion ankle sprain who were included in this study, the Mulligan technique were more effective in improving static balance indicators compared to the Maitland technique. Clinical TrialThe study was then registered in the Iranian Registry of Clinical Trials (17/02/2019) (IRCT20190108042292N2).

Oxytocin with calcium vs oxytocin for induction of labor in women with term premature rupture of membranes: a randomized controlled trial

BackgroundIntravenous calcium administration has shown promise in enhancing uterine contractions and reducing blood loss during cesarean section, but this regimen has not been compared in vaginal labor induction. ObjectiveTo determine the efficacy of oxytocin combined with calcium versus oxytocin alone for inducing labor among women with term premature rupture of membranes (PROM). Study designThis single-blind, randomized control trial was conducted between October 2022 and May 2023 in a tertiary university hospital. Patients diagnosed with PROM were randomly allocated into two groups. The intervention group received a bolus of 10 mL of calcium gluconate followed by a continuous infusion of oxytocin via a pump (n = 210), whereas the control group received only oxytocin infusion (n = 218). The primary outcome was successful vaginal deliveries within 24 hours of labor induction. Secondary outcomes included the interval from labor induction to delivery, vaginal delivery blood loss, and maternal and neonatal complications. ResultsBaseline characteristics, including maternal age, BMI, Bishop score before labor induction, were comparable between groups. The rate of vaginal delivery within 24 hours of labor induction was statistically higher in the intervention group (79.52% vs. 70.64%; P = 0.04). Participants in intervention group experienced a shortened interval between induction and delivery (10.48 h vs. 11.25h; P = 0.037), and demonstrated a higher success rate in induction of labor assessed by the onset of active phase (93.80% vs. 87.61%; P = 0.04) without increasing the cesarean rate. Reduced hemorrhage was presented in the intervention group (242.5ml vs. 255.0ml; P = 0.0015) while the maternal and neonatal outcomes were comparable between groups. ConclusionThe co-administration of calcium and oxytocin in labor induction among pregnancies with PROM was more efficient and safer than oxytocin alone. Our research suggests that the combination therapy of calcium and oxytocin may offer significant advantages during the process of labor induction and result in better outcomes.

A pilot randomised controlled trial of a telehealth-delivered brief ‘Sleeping Sound Autism’ intervention for autistic children

BackgroundAccess to behavioural sleep intervention is beneficial for autistic children, yet many families face barriers to access associated with location and time. Preliminary evidence supports telehealth-delivered sleep intervention. However, no studies have evaluated brief telehealth sleep intervention. To address this, we evaluated telehealth delivery of the brief behavioural Sleeping Sound Autism intervention, using a two-armed, parallel-group, non-blinded, pilot randomised controlled trial (RCT) design (trial registration: ANZCTR12620001276943). MethodSixty-one families of autistic children without intellectual disability (5–12 years, 46% female) with caregiver-reported moderate–severe behavioural sleep problems participated Australia-wide, randomised to an intervention (n = 30) or treatment as usual control group (n = 31). Intervention group participants were invited to attend two video-conference telehealth sessions and one follow-up phone call with a trained clinician. Survey data was collected from caregivers at baseline and three- and six-months post-randomisation, to evaluate feasibility, acceptability, and efficacy. Ten intervention group caregivers participated in end-of-study semi-structured interviews to explore their experiences. ResultsForty-nine caregivers completed surveys. At baseline, 87% felt positive and 84% felt confident about participating via telehealth, and 75% believed the program would improve child sleep. At three-months, intervention group caregivers (n = 24) reported the usefulness (100%) of and preference for (71%) telehealth, and 95.8% would recommend this sleep program to other families. A significant group by time difference was observed in child sleep (Children's Sleep Habits Questionnaire) with large effect sizes (d = 0.87–1.05), emotion and behaviour (Developmental Behavior Checklist 2) with moderate effect sizes (d = 0.40–0.57), and caregiver mental health (Kessler 10) with small to moderate effect sizes (d = 0.60–0.28), favouring the intervention group (n = 23). There were no significant group differences in child (Child Health Utility instrument) or caregiver (Assessment of Quality of Life) quality of life. However, there were individual differences in the clinical significance of improved child sleep. Qualitative data showed that whilst telehealth was convenient for caregivers, without attenuating the benefits of most key intervention features, not all children were able to engage effectively with the clinician via telehealth. ConclusionsThis first pilot RCT of a brief telehealth behavioural sleep intervention for primary-school-aged autistic children suggests that telehealth delivery is acceptable, feasible and likely efficacious in improving sleep in the short-term. Providing families with ongoing choice of mode of delivery (telehealth/in-person) and examining the person-environment fit of telehealth for autistic children is important.

The combined effect of physical exercise, pranayama, and diet on fatigue in adult cancer patients undergoing chemotherapy: a randomized controlled trial.

Cancer patients undergoing chemotherapy continue to experience significant fatigue, which affects their quality of life. The present study aims to evaluate the combined effect of comprehensive physical exercise, pranayama (regulated breathing practices of yoga), and dietary support intervention on fatigue in cancer patients undergoing chemotherapy. Non-advanced adult cancer patients undergoing chemotherapy (N = 52) were randomized into the intervention group (N = 26) or control group (N = 26). Fatigue assessment was done using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (version 4) at baseline and after 3 months. The intervention group participants practiced physical exercise, slow-paced pranayama and supplemented their diet with an intake of 100 g of millet protein powder (MPP), commonly known as "Sattu" in India. The control group received standard medical care. A total of 39 patients (N = 13 in the intervention and N = 26 in the control group) were included in the statistical analysis. Within the intervention group, a statistically significant reduction in fatigue (p = 0.002) with a large effect size (d = 2.1) was observed. There was no statistically significant reduction in fatigue within the control group (p = 0.36). The group comparison showed a statistically significant reduction in post-scores of fatigue (p < 0.0001) in the intervention group as compared to the control group with a moderate effect size (R = 0.1). No unintended adverse effects related to the intervention were observed. The results suggest the potential role of integrated physical exercise, pranayama, and dietary support in reducing fatigue in cancer patients undergoing chemotherapy. Further validation with a larger sample size is required. CTRI/2022/04/041717 [Registered prospectively on 07/04/2022].

Skill Enactment Among University Students Using a Brief Video-Based Mental Health Intervention: Mixed Methods Study Within a Randomized Controlled Trial.

Mental health problems are common among university students, yet many students do not seek professional help. Digital mental health interventions can increase students' access to support and have been shown to be effective in preventing and treating mental health problems. However, little is known about the extent to which students implement therapeutic skills from these programs in everyday life (ie, skill enactment) or about the impact of skill enactment on outcomes. This study aims to assess the effects of a low-intensity video-based intervention, Uni Virtual Clinic Lite (UVC-Lite), in improving skill enactment relative to an attention-control program (primary aim) and examine whether skill enactment influences symptoms of depression and anxiety (secondary aim). The study also qualitatively explored participants' experiences of, and motivations for, engaging with the therapeutic techniques. We analyzed data from a randomized controlled trial testing the effectiveness of UVC-Lite for symptoms of depression and anxiety among university students with mild to moderate levels of psychological distress. Participants were recruited from universities across Australia and randomly assigned to 6 weeks of self-guided use of UVC-Lite (243/487, 49.9%) or an attention-control program (244/487, 50.1%). Quantitative data on skill enactment, depression, and anxiety were collected through baseline, postintervention, and 3- and 6-month follow-up surveys. Qualitative data were obtained from 29 intervention-group participants through open-ended questions during postintervention surveys (n=17, 59%) and semistructured interviews (n=12, 41%) after the intervention period concluded. Mixed model repeated measures ANOVA demonstrated that the intervention did not significantly improve skill enactment (F3,215.36=0.50; P=.68). Skill enactment was also not found to influence change in symptoms of depression (F3,241.10=1.69; P=.17) or anxiety (F3,233.71=1.11; P=.35). However, higher levels of skill enactment were associated with lower symptom levels among both intervention and control group participants across time points (depression: F1,541.87=134.61; P<.001; anxiety: F1,535.11=73.08; P<.001). Inductive content analysis confirmed low levels of skill enactment among intervention group participants. Participants were motivated to use techniques and skills that were perceived to be personally relevant, easily integrated into daily life, and that were novel or had worked for them in the past. The intervention did not improve skill enactment or mental health among students with mild to moderate psychological distress. Low adherence impacted our ability to draw robust conclusions regarding the intervention's impact on outcomes. Factors influencing skill enactment differed across individuals, suggesting that it may be necessary to tailor therapeutic skills and engagement strategies to the individual user. Theoretically informed research involving collaboration with end users is needed to understand the processes underlying skill enactment in digital mental health interventions. Australian New Zealand Clinical Trials Registry ACTRN12621000375853; https://tinyurl.com/7b9ar54r.

Effect of web-based education intervention on blood glucose control, self-care and quality of life in patients with type 2 diabetes: A single-blinded randomized controlled trial.

This study aimed to assess the effects of web-based education on blood glucose control, self-care and quality of life in patients with type 2 diabetes. A single-blinded randomized controlled trial was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist at a university hospital in Turkey. The study included 89 patients with type 2 diabetes who were randomly divided into an intervention group (44) and a control group (45). Participants in the intervention group participated in a 3-month web-based education programme. The findings indicated that there were no significant differences in sociodemographic characteristics and illness features between the intervention and control groups, and both were homogeneous. A statistically significant decrease of 0.71 was observed in the HbA1c (%) level of the intervention group following web-based education. Following web-based education, there was a significant difference in body mass index (kg/m2) and waist circumferences (cm) between the intervention and control groups. The intervention group displayed significantly improved self-care and quality of life over the 3-month period (p < 0.05). This study suggests that web-based education can enhance the self-care and quality of life of patients with type 2 diabetes.