JMIR Research Protocols最新文献

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.

Background: Prophylaxis for chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) is essential. Four-drug antiemetic therapy, consisting of a neurokinin-1 receptor antagonist (NK1RA), a 5-hydroxytryptamine type 3 receptor antagonist (5-HT3RA), dexamethasone (DEX), and olanzapine (OLZ), is currently recommended for HEC. However, the efficacy, optimal dosing schedule, and appropriate dosage of OLZ remain unclear when combined with a highly selective NK1RA, fosnetupitant (FosNTP).

Objective: This study aimed to evaluate the efficacy and safety of a four-drug antiemetic regimen including FosNTP and OLZ for prophylaxis of CINV in patients receiving anthracycline-based (neo)adjuvant chemotherapy for early breast cancer (EBC) and to explore outcomes with OLZ dose adjustments in the second cycle.

Methods: This single-institution, prospective observational study will enroll 100 patients with EBC who undergo HEC. All patients will receive a four-drug antiemetic regimen consisting of FosNTP, 5-HT3RA, DEX, and the guideline-recommended dose of OLZ administered orally from days -1 to 4. During the second cycle of treatment, OLZ dosing may be adjusted based on tolerability and patient preference. The primary endpoint is the proportion of patients who experienced no nausea during the overall phase (0-120 h) of the first cycle, as assessed using the daily visual analog scale. A sample size of 86 was calculated to assess the efficacy of the four-drug antiemetic regimen, including OLZ, assuming an expected no nausea rate of 42%, a threshold no nausea rate of 27% based on historical data, 90% power, and a 1-sided significance level of 5.0%. A single-sample z-test with a normal approximation will be used for the analyses.

Results: This study was approved by the Ethics Committee of the National Hospital Organization Kyushu Cancer Center, and participant recruitment and data collection commenced in May 2024. As of September 2025, approximately 70 participants have been recruited. Data collection is expected to continue until April 2026, and both data collection and analyses are anticipated to be completed in 2027.

Conclusions: This study will provide real-world evidence on the effectiveness and safety of a four-drug antiemetic regimen, including FosNTP and OLZ, in patients receiving anthracycline-based HEC and may inform optimal OLZ dosing strategies.

Background: Internationally, physical activity is successfully integrated into academic lessons in primary schools, showing promising results on cognition and student engagement. However, there is a lack of knowledge about its effects and feasibility for individual situated learning processes in upper secondary school.

Objective: This protocol describes the design and methods of the Physically Active Academic Lessons (PAAL) study, a mixed methods, cluster randomized, individual crossover trial. The PAAL study aims to examine the acute effects of physically active academic lessons on cognitive prerequisites of learning (alertness and executive functions) and situational engagement (behavioral, cognitive, and emotional engagement; disaffection; competence experiences; and help seeking), as well as factors modifying these effects (physical and mental load and perceived physical and academic competence). Further, subject teachers' and students' experiences and perceptions of physically active academic lessons in general upper secondary school will be explored.

Methods: The first part of the PAAL study involves exploring subject teachers' experiences of facilitators, barriers, usefulness, and the meaning of physically active academic lessons for the situational learning process through semistructured interviews with 14 teachers. The second part consists of a cluster‑randomized individual crossover trial including 168 students in mathematics and foreign language lessons, followed by interviews with 30 students.

Results: Funding for the study was obtained in May 2023. Ethical approval for the teacher interviews was granted in September 2023, and for the student trial in December 2023. Data collection was completed between October 2023 and November 2024. Data analysis is ongoing. The findings of the study will provide essential evidence-based information on physically active classroom practices that support teachers and schools in implementing pedagogical methods that enhance student learning and well-being in upper secondary schools.

Conclusions: The background, design, content of the intervention, and methods of the PAAL study are presented. This study aims to address a gap in the literature regarding the feasibility and effectiveness of physically active methods during academic lessons in upper secondary school.

Background: National birth rates among adolescents have consistently decreased since 1991, yet substantial disparities remain, particularly among youth in foster care, who experience higher risks of unintended pregnancies and sexually transmitted infections. Few sexual health programs rarely address the specific needs of foster youth or incorporate youth perspectives into their design, development, and implementation.

Objective: This study aims to refine, pilot-test, and evaluate Next4You, a fully mobile, youth-centered sexual health education platform tailored specifically for adolescents in or transitioning from foster care. The program intends to reduce sexual risk behaviors and related psychosocial outcomes by promoting healthy relationships, sexual wellness, contraception use, communication skills, self-respect, and wellness education.

Methods: Next4You is a fully mobile, self-paced, 4-week intervention evaluated using an individual-level randomized controlled trial involving a target sample of 500 youths aged 16-19 years with current or previous foster care experience in California. Participants are randomly assigned to either the intervention group, which receives access to Next4You modules, or the comparison group, which accesses general health materials through a similar web platform. Both groups complete baseline, 3-month, and 9-month follow-up surveys. Immediately following the 9-month follow-up survey, participants in each group receive access to the platform they were not initially assigned. Data collection assesses contraceptive behaviors, sexual communication, consent self-efficacy, and knowledge related to health rights and financial literacy. Intervention engagement is tracked through platform analytics, and qualitative interviews supplement data collection. Data analysis will adhere to intent-to-treat principles, using multilevel regression models to assess impacts.

Results: Funding was awarded in 2021, with institutional review board approval in October 2022. Intervention development lasted approximately 7 months, engaging foster youth in a co-design process to ensure relevance and cultural competence. Study recruitment began in September 2023, continuing until May 2025. Final data collection is anticipated by March 2026, followed by data analysis.

Conclusions: Next4You presents an innovative approach to sexual health education by addressing critical gaps in sexual health education for foster youth through mobile technology. If effective, Next4You could provide another evidence-based option for promoting sexual health among foster youth, guiding policymakers and practitioners in adopting similar trauma-informed and youth-centered interventions.