Virtual Reality for Pain in Acute Orthopedic Injuries
- Conditions
- InjuriesInjury ArmInjurySportsInjury, KneeInjury WristInjury, AnkleInjury FootInjury, HandInjury Finger
- Registration Number
- NCT05552430
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> 1. Outpatient adults in the Level 1 Trauma Center<br><br> 2. Age 18 or older<br><br> 3. Able to meaningfully participate meaningfully (English fluency and literacy) and<br> stable living situation<br><br> 4. Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months<br> earlier (acute phase).<br><br> 5. Pain Catastrophizing Scale =20 or Pain Anxiety Symptom Scale-20 =40<br><br> 6. Has access to internet (Wi-Fi or wireless)<br><br> 7. Willing to participate and comply with the requirements of the study protocol,<br> including virtual reality program and questionnaire completion No psychotropics or<br> stable for >6 weeks<br><br> 8. Free of concurrent psychotropic medication for at least 2 weeks prior to initiation<br> of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks<br> and willing to maintain a stable dose (i.e., no psychotropics or stable for >6<br> weeks)<br><br> 9. Cleared by orthopedic surgeon for study participation<br><br>Exclusion Criteria:<br><br> 1. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or<br> other neurological diseases that are contraindicated for VR<br><br> 2. Medical condition predisposing to nausea or dizziness.<br><br> 3. Hypersensitivity to flashing light or motion.<br><br> 4. Vision or severe hearing impairment.<br><br> 5. Injury to eyes, face, or neck that impedes comfortable use of virtual reality<br><br> 6. Diagnosed with a medical illness expected to worsen in the next 3 months (e.g.,<br> malignancy)<br><br> 7. Other serious injuries that occurred with the orthopedic injury or surgical<br> complications (e.g., infection, need for repeat surgery)<br><br> 8. Current or prior untreated mental illness, substance use disorder, or suicidal<br> ideation<br><br> 9. Self-reported pregnancy<br><br> 10. Currently in litigation or under Workman's Comp<br><br> 11. Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body<br> techniques once per week for 45 minutes or more within the last 3 months
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale;Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale;Client Satisfaction Questionnaire;System Usability Scale
- Secondary Outcome Measures
Name Time Method Patient's Global Impression of Change;Motion Sickness and Nausea;Feasibility of Enrollment;Acceptability of Treatment;Adherence to Pain Surveys;Feasibility of Outcome Assessments