Clinical Trials Logo

Clinical Trial Summary

The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.


Clinical Trial Description

This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05552430
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase N/A
Start date October 17, 2022
Completion date October 12, 2023

See also
  Status Clinical Trial Phase
Completed NCT03285009 - Movement Patterns in Young Volleyball Athletes N/A
Recruiting NCT05487768 - Functional Connectivity After Anterior Cruciate Ligament Reconstruction N/A
Not yet recruiting NCT06195631 - Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy N/A
Completed NCT02329340 - Safety Skills Training: Parents of School-Aged Children Phase 2
Not yet recruiting NCT05529017 - Post Injury Performance Deficits in Rink Hockey
Recruiting NCT05910515 - Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills N/A
Completed NCT04096196 - A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours N/A
Completed NCT06264323 - Incidence of Acute Injuries in Boxing
Completed NCT06039358 - Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Not yet recruiting NCT05549830 - Effect of Different Positioning Before, During and After Surgery on Pressure Injury N/A
Active, not recruiting NCT00852085 - Reducing Youthful Dangerous Driving Phase 1/Phase 2
Not yet recruiting NCT06302088 - The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals N/A
Recruiting NCT03517475 - Tailoring a Home Supervision Intervention for Low-Income Families N/A
Completed NCT03108820 - Trauma Medical Home for Older Injured Patients N/A
Active, not recruiting NCT05629156 - Injury and Illness Surveillance at the FIFA World Cup Qatar 2022TM
Completed NCT05121649 - Video-instructed First Aid in Emergency Medical Call Centers
Active, not recruiting NCT04469036 - Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center N/A
Completed NCT04103437 - Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis