JMIR Research Protocols最新文献

Background: Tuberculosis (TB) in children is one of the most significant public health crises in Somalia. This issue is aggravated by the fact that only 36.7% of children aged 12 to 23 months receive the Bacillus Calmette-Guérin (BCG) vaccine in Somalia, which helps prevent TB-disseminated diseases. Among the major factors that contribute to poor BCG uptake and TB prevention practices are the lack of maternal knowledge, negative attitude, and poor self-efficacy toward the BCG vaccine and TB prevention practices. As such, pregnant women play a vital role in ensuring timely, routine BCG vaccination for their newborns and adherence to TB prevention practices.

Objective: This study aims to develop, implement, and evaluate the impact of health education intervention using the information-motivation-behavioral (IMB) skills model to improve knowledge, attitudes, and self-efficacy regarding BCG uptake and TB prevention among pregnant women in Banadir Hospital.

Methods: This single-blind randomized controlled trial enrolled a sample of 370 pregnant women recruited at Banadir Hospital in Mogadishu, Somalia. Eligible participants will be randomized to an intervention group receiving an IMB-based health education and to a waiting list control group, in a 1:1 ratio. Outcome assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up. The primary outcomes are BCG vaccine uptake and TB prevention practices. Secondary outcomes include knowledge, attitudes, and self-efficacy related to the BCG vaccine and TB prevention practices. The IMB-based health education intervention program consists of 6 sessions, with 1 group per session, and with each session containing 30 participants. The effects of the intervention will be assessed by handing out the same self-administered questionnaires at baseline, 2-month postintervention, and 4-month postintervention.

Results: A total of 370 pregnant women were recruited at baseline in November 2021, with 185 assigned to the intervention group and 185 assigned to the control group. In January 2022, the 185 pregnant women enrolled in the intervention program and completed the sessions by February 2022. Data collection for the 2-month and 4-month postintervention assessments was completed in June 2022. The findings of this study will be reported by the beginning of 2026.

Conclusions: The developed health education intervention module in this study has the potential to be adopted and included as part of routine antenatal care services. Its implementation could effectively raise awareness among pregnant women in Somalia regarding the importance of BCG vaccination and TB prevention practices, ultimately mitigating childhood mortality rates associated with TB-disseminated diseases in the country.

Background: Studies suggest that 40% to 65% of stroke survivors develop chronic poststroke pain (CPSP), which severely affects their quality of life and mental health. Empirical evidence suggests that existing treatments often fall short, underscoring the need for innovative, integrative interventions. Virtual reality (VR) seems to provide valuable tools in stroke rehabilitation. Also, contextual-behavioral psychological approaches, such as acceptance and commitment therapy (ACT), offer promising pain management and mental health resources, which seem to be feasible in VR formats. However, their combined application in CPSP remains unexplored.

Objective: This study protocol describes the VR-ACT study, which will test the feasibility and preliminary efficacy of an 8-week VR-ACT program for CPSP.

Methods: This pilot randomized controlled trial (N=30) will compare a VR-based ACT intervention with a sham VR control. The study will follow a mixed methods approach. Quantitative outcomes include pain intensity, psychological symptoms, and quality of life (via self-report measures), and brain network connectivity of the Triple Network (via functional magnetic resonance imaging). Feasibility will be evaluated through adherence, engagement, and acceptability. Qualitative feedback will be collected postintervention.

Results: This study was funded by the Portuguese Foundation for Science and Technology in February 2025. Data collection is expected to start in December 2025 and end in June 2026. Results are expected to be published in the fall/winter of 2026/2027.

Conclusions: This trial is expected to support the hypothesis that a VR-delivered ACT program is a feasible, acceptable, and potentially effective tool to support pain self-management and mental health in patients with CPSP, thereby laying the groundwork for larger multicenter trials.

Background: Falls are the primary cause of fatal and nonfatal accidental injuries in older adults. The World Falls Prevention Guidelines recommend balance-challenging, functional exercise programs as a key strategy for falls prevention, but access, uptake, and adherence to these programs in community settings remain suboptimal. Keep-On-Keep-Up (KOKU), a digital, National Health Service-approved program, was codeveloped with older adults and therapists to provide progressive, evidence-based exercises and to raise awareness of falls prevention strategies.

Objective: This trial aims to investigate the effectiveness and cost-effectiveness of the KOKU digital strength and balance program for improving balance, enhancing physical function, and reducing falls risk among community-dwelling older adults.

Methods: This is a 2-arm, parallel-group randomized controlled trial. A total of 196 community-dwelling older adults 60 years and older will be randomized to either the intervention group, comprising a digital strength and balance program (KOKU) alongside standard care (strength and balance exercise advice and a falls prevention leaflet), or to a control group, receiving standard care only. Participants receiving the intervention will be asked to exercise 3 times per week following the tailored and progressive program. Randomization will take place after recruitment and baseline data collection. The trial's primary outcome measure is balance function (Berg Balance Score) at 12 weeks post randomization. Secondary trial outcomes include lower limb strength, health care utilization and health-related quality of life, self-reported concerns about falling, self-reported physical activity, falls risk, pain, mood, fatigue, self-reported falls, and acceptability and usability of the KOKU program. Intention-to-treat analysis and a cost-effectiveness analysis will be employed for trial data analysis. Qualitative interviews and focus groups will be undertaken with around 10 care providers and 13 participants to further understand views of the intervention and trial processes.

Results: This study began recruitment in July 2024 and concluded in March 2025, recruiting a total of 202 participants (102 intervention group and 100 control group). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in 2027.

Conclusions: This trial will provide important evidence on whether a digital strength and balance program can improve balance and related outcomes in older adults compared with usual care.

Background: Knee osteoarthritis (KOA) is a prevalent degenerative joint disease that is characterized by joint pain, stiffness, and dysfunctional impairment, imposing a substantial medical burden annually. Tuina, a widely used noninvasive traditional Chinese medicine therapy commonly used for KOA, has been used for the management of this condition; however, its additive benefit to acupuncture remains unclear.

Objective: The objective of the study is to assess whether the effectiveness of acupuncture-combined Tuina is superior to that of acupuncture in the management of KOA.

Methods: This single-center, parallel-group, randomized controlled trial aims to enroll 60 patients with KOA, who will be randomly assigned to either a Tuina group (acupuncture-combined Tuina) or an acupuncture group (30 patients per group). Baseline assessments will include demographic and clinical evaluations: the visual analog scale from the short-form McGill Pain Questionnaire, pain threshold, muscle tension, 10-meter walking test, Western Ontario and McMaster Universities Osteoarthritis Index, and multimodal magnetic resonance imaging. Over a 6-week intervention, the Tuina group will receive Tuina on the basis of acupuncture, that is, acupuncture-combined Tuina, while the acupuncture group will undergo just acupuncture, with both groups continuing standard care as prescribed. Posttreatment, clinical outcomes and safety will be reassessed using baseline indicators. A 12-week follow-up will include all clinical evaluations. Assessments will be conducted by blinded assessors, and statistical analyses will be conducted by independent, blinded analysts. Outcomes will evaluate clinical pain and functional differences between groups and will elucidate the underlying cerebral mechanisms.

Results: This study was funded in August 2024. The experimental plan will begin on December 31, 2025, and end on May 4, 2027.

Conclusions: This trial aims to verify whether acupuncture-combined Tuina receives better efficacy than single acupuncture, as well as to explore the neuroimaging mechanisms that are clinically affected, thus providing scientific evidence for the treatment of clinical patients with KOA.

Background: Serious mental illnesses (SMIs) are associated with high relapse rates and limited access to continuous care, particularly in low-resource settings such as urban slums. Traditional clinical monitoring is constrained by accessibility and scalability challenges. Digital phenotyping, through passive smartphone data, offers a novel approach to predict relapse by capturing real-world behavioral changes.

Objective: This study aims to evaluate the feasibility and predictive value of smartphone-based digital phenotyping for detecting relapse in individuals with SMIs living in the Korail slum of Dhaka, Bangladesh.

Methods: This prospective 6-month cohort study will recruit 430 participants diagnosed with SMIs who own Android (Google LLC) smartphones. Passive data (eg, screen time, mobility, and call or text frequency) will be continuously collected using a custom-built app (DataDoc). Monthly active data, including symptom and functioning assessments, will be collected via self-report and clinical engagement. Machine learning models will integrate these data to detect early warning signs and predict relapse trajectories.

Results: This study was funded by the NIHR (National Institute for Health and Care Research; award number NIHR200846) in October 2022. Data collection commenced in August 2025 and is ongoing. A total of 14 participants have been recruited, as of January 2026. Preliminary data analysis is ongoing, with expected results to be published in fall 2026.

Conclusions: This study is one of the first to apply smartphone-based digital phenotyping and machine learning for relapse prediction in low- and middle-income countries' slum settings. The findings will inform scalable, low-cost digital interventions to address the mental health treatment gap in underresourced communities.

Background: Although physical activity (PA) participation has known health benefits, many individuals with hypermobility spectrum disorders (HSD) and hypermobile Ehlers-Danlos syndrome (hEDS) have difficulties participating in PA. HSD/hEDS affect approximately 1 in 500 people and are more prevalent in females. HSD/hEDS may result in frequent joint injuries, chronic pain, and generalized fatigue. These symptoms, and a fear of new or reinjury, may result in barriers to PA participation. Overall, there is limited research on PA in this population. Previous exercise reviews have not included structured PA such as sports and occupational activities; unstructured PA such as play, household, or leisure activities; or younger ages, including children. Additionally, some females with HSD/hEDS report experiencing more frequent joint injuries and worsening pain and fatigue during times of hormonal transitions, such as puberty, pregnancy, as well as cyclically across the menstrual cycle. Some females also report improvements in symptoms and a reduction in injury frequency following menopause. The impacts of PA during these times of changing hormone levels for females living with HSD/hEDS are uncertain. A clear understanding of what types of structured and unstructured PA are safe and helpful for individuals of all ages with HSD/hEDS, and if PA should be adapted during times of female hormonal changes, is lacking.

Objective: We propose a scoping review protocol to map and synthesize the evidence regarding considerations that may impact structured and unstructured PA participation in HSD/hEDS for individuals of all ages and during times of female hormonal transitions.

Methods: A scoping review will be conducted using Covidence (Veritas Health Innovation Ltd) and Microsoft Excel (Microsoft Corp) to map the evidence regarding the impacts of PA on safety, physical health, and quality of life. These outcomes will be assessed using the World Health Organization International Classification of Functioning, Disability and Health framework.

Results: The database search was performed on August 22, 2024, and updated on September 8, 2025. Data extraction started in September 2025 and is ongoing. The results are expected to be published by August 2026.

Conclusions: This proposed scoping review will aid in defining critical research directions regarding PA in HSD/hEDS, which may help inform guidelines outlining the risks and benefits of structured and unstructured PA. This review will also help define existing evidence for age-specific and hormone-related considerations regarding the impacts of PA in this population. This is particularly important as PA may help ameliorate the physical and mental symptoms associated with HSD/hEDS and may improve quality of life for these individuals across the lifespan.

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is crucial for managing pediatric hepatobiliary diseases but frequently results in postoperative gastrointestinal dysfunction such as delayed flatus and defecation, which can prolong recovery and increase the risk of complications. Nonpharmacological interventions such as acupoint massage and mirabilite application offer potential benefits, but evidence for their efficacy and synergy in children after ERCP is lacking.

Objective: This study aims to evaluate the individual and combined effects of acupoint massage and abdominal mirabilite application on accelerating gastrointestinal recovery in pediatric patients following ERCP.

Methods: A single-center, single-blind, randomized controlled trial will be conducted involving 72 children aged between 2 and 12 years who have undergone ERCP. Participants will be randomly allocated to 1 of the 4 groups: acupoint massage group (stimulating ST-36, ST-25, CV-12, and PC-6 for 2 minutes per point; twice daily), mirabilite group (abdominal application for 1 hour; twice daily), combination group (both interventions; at least 1 hour apart), or conventional care group. The primary outcome is the time to first postoperative flatus and defecation. The secondary outcomes include the frequency of postoperative nausea and vomiting and inflammatory markers. Data will be analyzed using intention-to-treat analysis with SPSS, using ANOVA, chi-square, and nonparametric tests as appropriate.

Results: This trial is currently in progress, having received funding in January 2023 and July 2023. Participant recruitment commenced on November 1, 2024, with an anticipated completion date of October 30, 2026. As of January 2026, a total of 38 pediatric patients have been enrolled and randomized, while data collection and intervention delivery are ongoing. No interim analysis has been conducted. The final analysis will begin after recruitment and follow-up are complete, with primary results expected to be published in the second half of 2026.

Conclusions: This study is the first to rigorously assess the efficacy and potential synergistic effects of acupoint massage and mirabilite application for enhancing gastrointestinal recovery after pediatric ERCP. Positive findings could establish a safe, nonpharmacological protocol to improve postoperative outcomes, reduce hospital stays, and minimize complications in this vulnerable population.

Trial registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000670; https://itmctr.ccebtcm.org.cn/mgt/project/view/3385640124071694411.

International registered report identifier (irrid): DERR1-10.2196/87961.