JMIR Research Protocols最新文献

{"title":"Comparative Efficacy of Virtual Reality-Assisted Cognitive Behavioral Therapy Versus Yoga-Based Interventions for Reducing Performance Anxiety in Students: Protocol for a Randomized Controlled Trial.","authors":"Cristina Maria Tofan, Liviu-Adrian Măgurianu, Magdalena Axinte, Alexandra Maria Găină, Marcel Găină","doi":"10.2196/66112","DOIUrl":"10.2196/66112","url":null,"abstract":"<p><strong>Background: </strong>Performance anxiety represents a significant challenge for students, manifesting as a fear of failure and difficulties managing examination-related concerns and academic pressures. According to recent statistics, anxiety affects >4% of the global population, underscoring the need for effective management methods. Studies indicate that yoga and virtual reality (VR) training can alleviate symptoms of performance anxiety.</p><p><strong>Objective: </strong>This trial aims to compare VR-assisted cognitive behavioral therapy (CBT) with yoga interventions to find effective treatments.</p><p><strong>Methods: </strong>A single-blinded randomized controlled trial will be conducted with 60 participants (n=30, 50% per intervention group) recruited from university and preuniversity counseling centers. The trial will measure whether the interventions reduce performance anxiety in students. Stratified randomization will be used to ensure equal distribution of baseline anxiety levels and gender across both groups. The primary outcome is a reduction in anxiety, measured using the State-Trait Anxiety Inventory-Y1 and State-Trait Anxiety Inventory-Y2 subscales. Secondary outcomes include emotional regulation and quality of life. Data will be collected at baseline, after the intervention, and during follow-up assessments. Statistical analyses will include parametric tests (eg, repeated-measures ANOVA and t tests) to compare anxiety reduction, emotional regulation, and quality of life across groups. The intention-to-treat approach will be applied to minimize bias due to participant dropouts. Sensitivity analyses will assess the robustness of the findings.</p><p><strong>Results: </strong>This study is planned to start in September 2025 and end in June 2026. VR-assisted CBT is expected to reduce anxiety very quickly, whereas yoga is predicted to have long-term benefits.</p><p><strong>Conclusions: </strong>More generally, this research highlights the need for new, accessible forms of mental health support. VR-assisted CBT is an emerging digital mental health intervention, and it enables individuals to access and explore anxiety in virtual, safe environments. In contrast, yoga is a more conventional, all-encompassing discipline that enhances mental health through physiological and psychological processes that may have long-term effects.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06639841; https://clinicaltrials.gov/study/NCT06639841.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/66112.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66112"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144528041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In Vitro Characterization of the Immune Response to an Epitope Ensemble Vaccine Against Rhinovirus in Pediatric Asthma and Adults With Chronic Obstructive Pulmonary Disease: Protocol for an Observational and Exploratory Study.","authors":"Sara Alonso Fernandez, Raquel Reyes-Manzanas, Susana Camara, Juan Mozas-Gutierrez, Myriam Calle-Rubio, Juan Rodriguez-Hermosa, Andres Bodas-Pinedo, Santiago Rueda Esteban, Esther M Lafuente, Jesús Reiné, Pedro A Reche","doi":"10.2196/73383","DOIUrl":"10.2196/73383","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Human rhinoviruses (HRVs) are the leading cause of upper respiratory tract infections, responsible for over half of all such infections. Infection rates among young children can reach as high as 8-12 episodes per year. While HRV infections typically result in mild common colds, they can also lead to more severe respiratory conditions, often in conjunction with bacterial coinfections. In addition, HRVs are implicated in the exacerbation of obstructive respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD). T-cell responses play a crucial role in the immune defense against HRV. However, in patients with obstructive respiratory diseases, altered or dysregulated T-cell responses to HRV may not only fail to efficiently eliminate the virus but can also exacerbate inflammation and airway remodeling. Therefore, a deeper understanding of T-cell-mediated responses in the context of HRV infection, especially in vulnerable populations like those with COPD, is critical. It can provide new insights into mechanisms of both protection and disease exacerbation, potentially guiding the development of targeted therapies or vaccines that enhance protective immunity while minimizing harmful inflammation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to (1) determine the population-wide coverage of HRV-specific T-cell responses, (2) characterize HRV-specific T-cell recall responses in disease cohorts compared to age-match healthy controls, and (3) identify biomarkers of protection and susceptibility within disease cohorts through a comparative analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants with asthma and those with COPD, aged 5-15 and 40-70 years, respectively, will be recruited alongside healthy age-matched controls. Peripheral blood samples will be collected following informed consent from adult participants and from parents or guardians of minors, as applicable. Clinical, demographic, immunological, and genetic responses will be assessed both prior to and following in vitro stimulation with a pool of HRV-specific T-cell epitopes. Flow cytometry and functional assays will be used to analyze T-cell responses to HRV epitopes in the context of obstructive respiratory diseases.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in January 2023 by the Ministry of Science and Innovation of Spain. The primary aim of the study was achieved within the same year. Recruitment for the secondary and tertiary aims is currently ongoing. Preliminary findings highlight the potential significance of HRV-specific T-cell responses in individuals with asthma and those with COPD. A detailed characterization of these immune responses will provide critical insights into host-pathogen interactions and may serve as a foundation for the development of effective T-cell-based vaccines or immunotherapies targeting HRV.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Here, we present an ethically approved study protocol for an o","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73383"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144528042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effectiveness of Virtual Reality-Based Mindfulness Interventions for Managing Stress, Anxiety, and Depression: Protocol for a Systematic Review and Meta-Analysis of Randomized Controlled Trials.","authors":"Ravi Shankar, Anjali Bundele, Amartya Mukhopadhyay","doi":"10.2196/68231","DOIUrl":"10.2196/68231","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;While traditional mindfulness-based interventions demonstrate effectiveness in improving mental health outcomes, their delivery methods face significant challenges related to accessibility and engagement. Geographic barriers to trained facilitators, time constraints for in-person sessions, and participant dropout rates of 15% to 30% due to perceived monotony limit intervention reach and effectiveness. Virtual reality (VR) technology offers innovative solutions through multisensory immersion that creates presence, the subjective feeling of \"being there,\" enhancing attention regulation and reducing external distractions. Meta-analyses demonstrate that VR interventions achieve higher engagement rates and lower dropout compared to traditional delivery methods; however, systematic evaluation of VR-based mindfulness interventions remains limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;Following the population, intervention, comparison, and outcome framework, this systematic review protocol aims to evaluate whether VR-based mindfulness interventions (intervention), compared to traditional face-to-face mindfulness interventions, digital mindfulness apps, active nonmindfulness controls, and waitlist or no-treatment groups (comparisons), effectively reduce stress, anxiety, and depression while improving mindfulness and well-being (outcomes) in adults aged 18 to 65 years from both general and clinical populations with diagnosed mental health conditions (population).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will conduct comprehensive searches across 8 databases (PubMed, Web of Science, Embase, CINAHL, MEDLINE, the Cochrane Library, PsycINFO, and Scopus) from inception to June 2025, including gray literature and unpublished trials. Eligible studies include randomized controlled trials evaluating VR-based mindfulness interventions using immersive technology (head-mounted displays and cave environments) with explicit mindfulness content in adult populations. Primary outcomes include stress, anxiety, and depression; secondary outcomes encompass mindfulness levels, well-being, and user experience. Two independent reviewers will screen studies, extract data, and assess risk of bias using the Cochrane Risk of Bias 2 tool with standardized criteria. Meta-analysis will use random effects models with inverse variance weighting, calculating standardized mean differences with 95% CIs. Preplanned subgroup analyses will examine intervention duration (&lt;2 wk, 2-8 wk, and &gt;8 wk), VR technology type (head-mounted displays vs cave environments), population characteristics (clinical vs nonclinical samples), and mindfulness technique type, with heterogeneity quantification using prespecified I&lt;sup&gt;2&lt;/sup&gt; thresholds.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Database searches will commence in June 2025, with data extraction planned for August 2025 to September 2025 and systematic review completion planned by December 2025. Expected results include pooled effect sizes ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68231"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144528044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations Among Minority Stress, Allostatic Load, and Drug and Alcohol Use in Sexual Minorities: Protocol for the Queer Health Study-a Longitudinal Feasibility Evaluation.","authors":"Nathan Grant Smith, Tzuan A Chen, Robert-Paul Juster, Ezemenari M Obasi, Jacob S Crocker","doi":"10.2196/73070","DOIUrl":"10.2196/73070","url":null,"abstract":"<p><strong>Background: </strong>Substance use rates among sexual minorities are disproportionately greater than that of their heterosexual counterparts. Minority stress theory posits that one explanation for disproportionate substance use in sexual minority populations is a result of increased social stress associated with holding a minoritized identity. This minority stress has been linked to a myriad of negative mental health outcomes, including alcohol and drug use. In addition, emerging research has begun to demonstrate links between minority stress and stress physiology dysregulation. While animal and human models have demonstrated links between stress physiology dysregulation and substance use outcomes, to date, no studies have examined the role that stress physiology plays within a minority stress framework in predicting substance use among sexual minorities. The Queer Health Study was designed to explore the longitudinal links among minority stress, stress physiology (specifically, allostatic load, the cumulative \"wear and tear\" on the body and brain as a result of chronic stress), and substance use.</p><p><strong>Objective: </strong>This study aims to assess the feasibility of collecting longitudinal data to explore the temporal links between minority stress processes, allostatic load, and drug and alcohol use, as well as to obtain estimates of effect size to determine the appropriate sample size necessary to conduct a fully powered longitudinal study.</p><p><strong>Methods: </strong>This feasibility study is a 3-wave longitudinal design consisting of a self-report survey, researcher-assisted Timeline Followback to assess for drug and alcohol use, and blood and anthropometric data collection to measure allostatic load at each of the time points. A total of 40 ethnically and racially diverse sexual minority adult participants (aged 18-60 years) will be enrolled.</p><p><strong>Results: </strong>The study received University of Houston institutional review board approval on July 31, 2023 (STUDY00004277). Recruitment began in June 2024. As of February 2025, the initial sample of 46 participants completed the time 1 visit, and time 2 visits are ongoing. We estimate that all study activities will be completed by July 2025.</p><p><strong>Conclusions: </strong>Results can inform the development of targeted prevention and treatment interventions. In addition, this research will provide an innovative framework for exploring diverse risk and resilience factors impacting addiction in this at-risk population. Ultimately, results have important implications for public health and have the potential to reduce the many dire economic and health consequences of drug use and addiction.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/73070.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73070"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corticospinal Intermittent Theta Burst Stimulation Propelling Sensorimotor Function Recovery in Complete Spinal Cord Injury: Protocol for a Randomized Controlled Trial.","authors":"Deeksha Patel, Rohit Banerjee, Kamran Farooque, Deepak Gupta, Bhavuk Garg, Nand Kumar, Kanwal Preet Kochhar, Suman Jain","doi":"10.2196/66531","DOIUrl":"10.2196/66531","url":null,"abstract":"<p><strong>Background: </strong>Intermittent theta burst stimulation (iTBS) is a noninvasive stimulation technique to induce neuronal and synaptic plasticity. The induced cortical plasticity is imperative in the recovery of motor and sensory functions. Spinal cord injury (SCI) causes damage to neurons and results in sensorimotor dysfunction. The effect of iTBS on recovery of motor and sensory dysfunction in complete SCI (cSCI) is still elusive.</p><p><strong>Objective: </strong>This study aims to assess the effect of iTBS on corticospinal tract integrity, plasticity, and regaining of motor and sensory function in patients with cSCI. The rationale behind using an iTBS protocol is to modify and augment the communication between spared neurons of the corticospinal tract and strengthen the synaptic transmission, which will improve motor function in underlying muscles.</p><p><strong>Methods: </strong>A total of 40 patients with cSCI with American Spinal Injury Association (ASIA) grade A, aged 18-60 years, were randomly assigned to 5 groups. To evaluate the efficacy of iTBS versus traditional repetitive transcranial magnetic stimulation, patients were categorized into placebo, repetitive transcranial magnetic stimulation, and iTBS. In addition, to determine the optimal site for stimulation, groups were further subdivided into motor cortex, spinal cord, and combined. Each patient underwent 10 iTBS sessions twice daily for 5 consecutive days. Neurological outcomes and functional outcome parameters will be assessed. Electrophysiological evaluations included transcranial magnetic stimulation single-pulse and paired-pulse parameters. The effect of iTBS intervention on biomarkers will be quantified using the enzyme-linked immunosorbent assay, while neurotransmitters will be quantified by liquid chromatography and tandem mass spectrometry. Measurements will be done before and after the intervention, with follow-ups at 1, 2, and 3 months.</p><p><strong>Results: </strong>The outcome of the study will be defined by electrophysiological parameters elicited by single- and paired-pulse stimulation, ASIA score, pain, activities of daily life, quality of life, anxiety, depression, and biomarkers related to SCI. The results of this study will uncover the effectiveness of iTBS stimulation on (1) recovery of motor and sensory function in cSCI, (2) excitability of the corticospinal tract, (3) neurological recovery and modulation of pain, and (4) cortical reorganization after injury.</p><p><strong>Conclusions: </strong>iTBS in conjunction with an individualized rehabilitation program may serve as an integrated strategy to rejuvenate locomotor abilities and improve the overall quality of life for people with cSCI.</p><p><strong>Trial registration: </strong>Clinical Trials Registry- India CTRI/2022/11/047038; https://ctri.nic.in/Clinicaltrials/main1.php?EncHid=13361.98443.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66531.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66531"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Virtual Self-Management Intervention for Adolescents With Juvenile Idiopathic Arthritis: Protocol for the VISTA-JIA Randomized Controlled Trial.","authors":"Jessica Booth, Kathryn A Birnie, Kelsey Chomistek, Maria Santana, Jennifer N Stinson, Babatope O Adebiyi, Julia Brooks, Jaime Guzman, Robin Hellweg, Lily Sh Lim, Dax Rumsey, Brian M Feldman, Jamie Tagseth, Jennifer Wilson, Heinrike Schmeling","doi":"10.2196/69539","DOIUrl":"10.2196/69539","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Needs assessments in patients with juvenile idiopathic arthritis (JIA) have revealed a need for disease information, self-management skills, and peer support. We previously developed and tested the acceptability of an in-person and videoconference-based self-management program (SMP) to address these needs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this pilot randomized controlled trial (RCT; the VISTA-JIA trial) is to evaluate the feasibility and preliminary effectiveness of a virtual group-based SMP for adolescents with JIA in comparison to a waitlist control group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A total of 100 participants with confirmed JIA (aged 12-17 years) will be recruited from 5 Canadian pediatric rheumatology centers and randomized 1:1 to the intervention or waitlist control groups. Adolescents in the intervention group will receive the virtual SMP. Those randomized to the control group will receive standard of care alone and will later be eligible for the SMP. The SMP includes JIA disease education, self-management strategies, and peer support. Four 60- to 90-minute sessions will be conducted over 8 weeks with a group size of 4-6 participants. The primary feasibility outcome will be adherence to the SMP (defined as completion of all 4 sessions by at least 80% of participants). Other secondary feasibility outcomes will include recruitment and withdrawal rates, the proportion of completed questionnaires, engagement and satisfaction with the SMP measured through a semistructured virtual interview, and intervention fidelity (consistent content and technology delivery). Secondary preliminary effectiveness outcomes will be assessed by completing 5 validated questionnaires at pre- and postprogram time points: (1) the Medical Issues, Exercise, Pain, and Social Support Questionnaire to assess perceived ability to manage JIA (self-management); (2) the Children's Arthritis Self-Efficacy Scale to assess self-efficacy; (3) the Pediatric Quality of Life Inventory 3.0 Rheumatology-Teen Module to assess health-related quality of life; (4) the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference Scale to assess pain interference; and (5) Readiness for Adult Care in Rheumatology to assess transition readiness. Descriptive statistics and nonparametric tests will be used to analyze the data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study setup is complete at all centers, including training of the facilitators, revising and finalizing education sessions, participant's handout guide, and fidelity checklist. Recruitment began in January 2024 and is expected to conclude by December 2025. Feasibility outcomes, including adherence and engagement, as well as preliminary effectiveness, will be analyzed post intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This is the first evidence-based, virtual, interactive, group-structured JIA SMP in Canada. This SMP will address needs for disease informa","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69539"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Digital Library of Health Care Consultations and Simulated Health Care Student Teaching: Protocol for a Repository of Recordings to Support Communication Research.","authors":"Elizabeth Ann Sturgiss, Kimberley Norman, Terry Haines, Katrina Long, Suzanne Nielsen, Jenny Sim, Aron Shlonsky, Brendan Shannon, Cylie Williams","doi":"10.2196/67910","DOIUrl":"10.2196/67910","url":null,"abstract":"<p><strong>Background: </strong>Miscommunication in health care is a major source of poor health outcomes, complaints about health care professionals, and poor patient satisfaction. Recordings from real-life consultations provide valuable data for communication research and education. Additionally, recordings from simulation-based education of health care students can provide valuable data for health care education research.</p><p><strong>Objective: </strong>The Digital Library is a data repository supporting high-quality health care communication research. This is the single-source citation for all projects that use the Digital Library in Australia.</p><p><strong>Methods: </strong>This protocol outlines the logistics and consent process for recording and safely storing the recordings of health care consultations and simulation-based education. The processes are outlined for primary health care settings and health care educational settings as well as for health care narratives from consumers. The repository will be used to answer research questions about health care communication and provide a valuable resource for health care education.</p><p><strong>Results: </strong>Data collection for the Digital Library commenced in 2023 and is ongoing at the time of submission of this protocol. The Digital Library has been approved by Monash University's Human Research Ethics Committee.</p><p><strong>Conclusions: </strong>The Digital Library will provide a national resource for the study of health care communication in community settings, general practice, and other environments. The health care narratives may be a valuable resource for sharing the patient perspective when living with different conditions. The research that uses this repository will be shared through regular academic channels as well as the community-based dissemination strategies of the National Centre for Healthy Ageing.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/67910.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67910"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Cohesive Predictive Model for Substance Use Disorder Rehabilitation Using Passive Digital Biomarkers, Psychological Assessments, and Automated Facial Emotion Recognition: Protocol for a Prospective Cohort Study.","authors":"Andrea P Garzón-Partida, Kimberly Magaña-Plascencia, Diana Emilia Martínez-Fernández, Joaquín García-Estrada, Sonia Luquin, David Fernández-Quezada","doi":"10.2196/71374","DOIUrl":"10.2196/71374","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Substance use disorder (SUD) involves excessive substance consumption and persistent reward-seeking behaviors, leading to serious physical, cognitive, and social consequences. This disorder is a global health crisis tied to increased mortality, unemployment, and reduced quality of life. Altered brain connectivity, circadian rhythms, and dopaminergic pathways contribute to sleep disorders, anxiety, and stress, which worsen SUD severity and relapse. Factors like trauma and socioeconomic disadvantages heighten risk. Digital health technologies, including wearables and machine learning, show promise for diagnosis, monitoring, and intervention, from relapse prediction to early detection of comorbidities. With high relapse rates and younger patient cases, these innovations could enhance the treatment outcomes of SUD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this study is to develop and validate a predictive model with machine learning for the duration of therapy and the rehabilitation or relapse in patients with SUD, using digital physiological measurements, psychological profiles, automatic facial emotion recognition, and the emotional state during craving.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study will be conducted with adult male patients with SUD at a rehabilitation center and control volunteers. Participants will undergo a self-reported demographic and psychological assessment, a clinician-administered craving and emotional reaction test, and will also be monitored using a smartwatch. SUD participants will be monitored for a total of 18 months (6 months during rehabilitation, an additional 12 months post discharge), and control participants for a total of 6 months. All participants will be reassessed at the sixth month of monitoring. The collected data will then be used to train models with a neural network, which will then be validated against other models and compared with other algorithms. Demographic, psychological, digital biomarkers, and craving profiles will be created, correlations will be analyzed, and they will be compared with controls to generate a digital phenotype of SUD. When the model achieves adequate validity (area under the curve of ≥0.80), a graphic user interface will then be designed for clinical use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study is supported by the Program for the Improvement of Working Conditions for Members of the SNII and SNCA (PROSNII U006EST), and APPAC-VII-CUCS-2025 for Article Publication Fees, from the University of Guadalajara. The research protocol was approved by the University of Guadalajara (reference CI-01225) in January 2025. Recruitment of patients with SUD and control participants will take place from January 2025 through January 2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;As shown in recent studies, accessible and affordable wearables, like commercial smartwatches, combined with psychological, demographic, and emotional state data, used with a machine lea","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71374"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot Implementation of HIV Self-Testing Delivery in Private Pharmacies Combined With a Respondent-Driven Sampling Method to Improve HIV Testing for Men Who Have Sex With Men and Transgender Women in Phnom Penh (ANRS 0100s): Protocol for a Prospective Mixed Method Feasibility Study.","authors":"Chhavarath Dary, Olivier Ségéral, Joseph Larmarange, Emilie Mosnier, Mohamed Ben Mechlia, Vichea Ouk, Bruno Spire, Vonthanak Saphonn","doi":"10.2196/65351","DOIUrl":"10.2196/65351","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Regular testing is recognized as a key strategy for HIV control. The 2023 Integrated Biological and Behavioral Survey (IBBS) in Cambodia revealed that nearly one-third of men who have sex with men (MSM) and one-fourth of transgender women (TGW) were never tested for HIV or not for more than 12 months. The majority of MSM and TGW were tested at community-based organizations (CBOs) facilities and by CBO outreach workers, while private facilities are poorly used for HIV testing (6% for MSM and 9% for TGW). Private pharmacies could be able to deliver HIV self-testing kits giving the advantage of confidentiality, anonymity, and time savings, in particular for those reluctant to visit CBOs. The recruitment of participants using a respondent-driven sampling method could provide the opportunity to reach MSM and TGW outside the network of CBOs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This pilot study aims to evaluate the feasibility of free HIV self-testing delivery by a private pharmacy combined with a respondent-driven sampling method to improve HIV testing among MSM and TGW in Phnom Penh, Cambodia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Both qualitative and quantitative approaches are used in this prospective feasibility study. The protocol was approved by the National Ethics Committee for Health Research in Cambodia (N0 351 NECHR). MSM and TGW aged more than 18 years old will be recruited via a respondent-driven sampling method with seeds recruited at hot spots and on social networks. The seeds will then distribute electronic and paper coupons to their networks physically and via social media, messaging, and calling applications. Each recruited peer will bring the coupon to receive direct and free access to one HIV self-testing kit at partner pharmacies as well as 10 additional coupons to recruit members of their networks. As for quantitative analysis, data from the study website will be imported, appended into a single matrix using Stata version 18SE (StataCorp), and analyzed using descriptive statistics, with a statistical significance level of .05. After 6 months, a qualitative assessment will be conducted among users, providers, and policymakers or key stakeholders to evaluate the acceptability and appropriateness of the strategy and to identify the barriers, facilitators, and recommendations. All transcripts will be analyzed according to the 6-phase reflexive thematic approach by Braun and Clarke. The results will be reported by participant-based and provider-based issues. QSR NVivo V.14 for Windows will be used to manage the data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study was funded by Agence nationale de recherches sur le sida, les hépatites, et les maladies infectieuses émergentes (ANRS) in September 2023. Approval of the study protocol was successfully obtained from the NECHR in Cambodia and the Commission Nationale de l'Informatique et des Libertés (CNIL) in France (Autorisation Tacite) in February 2025. Data collection wi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65351"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254708/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation and Comparison of Pediatric Appendicitis Scores and Management Strategies (Project SPASMS): Protocol for a Prospective Multicenter Observational Study.","authors":"Wei Hao Lee, Sharon O'Brien, Elizabeth J Mckinnon, Simon Craig, Stuart Dalziel, Michael Collin, Natalie Phillips, Franz E Babl, Sarah Julia Davidson, Shane George, Shefali Jani, Doris Tham, Viet Tran, Meredith L Borland","doi":"10.2196/67941","DOIUrl":"10.2196/67941","url":null,"abstract":"<p><strong>Background: </strong>Abdominal pain is a common reason for children to attend the Emergency Department (ED) with acute appendicitis being the most common surgical cause. Various clinical prediction scores (CPSs) have been developed to assist in determining the risk of appendicitis; however, CPSs have been inadequately validated in children and haphazardly adopted in Australia and New Zealand (ANZ) EDs.</p><p><strong>Objective: </strong>This study aims to compare and validate various CPSs for diagnosing pediatric appendicitis in children presenting to ANZ EDs.</p><p><strong>Methods: </strong>This prospective multicenter observational study across 10 ANZ EDs is recruiting children 5-17 years presenting to participating EDs with acute right-sided or generalized abdominal pain lasting ≤7 days and clinician suspicion of appendicitis. CPSs will be calculated by the study team from clinician-recorded data and clinician gestalt recorded on a visual analog scale. Accuracy of CPSs will be assessed by the area under the receiver operating characteristic curve and proportions correctly identified as either low-risk or high-risk based on the CPSs published cutoffs. The final diagnosis of appendicitis will be confirmed on histopathology, and the absence of appendicitis confirmed by telephone, email, or a combination of both to follow up for those discharged directly from ED.</p><p><strong>Results: </strong>This study received funding in July 2023 and started enrolment in August 2023. As of October 2024, we have enrolled and completed follow-up on 1227 participants with an expected end date in mid-2025.</p><p><strong>Conclusions: </strong>This study aims to determine the best-performing CPS for diagnosing pediatric appendicitis in ANZ EDs. Implementation of this CPS in ANZ EDs has the potential to reduce health care costs, rationalize the use of health care resources, and improve the management and outcomes of childhood appendicitis.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry ACTRN12622001293752; https://tinyurl.com/242wwenx.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/67941.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67941"},"PeriodicalIF":1.4,"publicationDate":"2025-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12254709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144511955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}