N/A
N=10
Virtual Reality for Pain in Acute Orthopedic Injuries
Injuries · Injury Arm · Injury;Sports · Injury, Knee · Injury Wrist
Bottom Line
View on ClinicalTrials.gov: NCT05552430 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Aug 2024
Primary outcome: Primary: Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RelieveVRx (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale |
8 | — |
| PRIMARY Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale |
9 | — |
| PRIMARY Client Satisfaction Questionnaire |
9 | — |
| PRIMARY System Usability Scale |
8 | — |
| SECONDARY Patient's Global Impression of Change |
10 | — |
| SECONDARY Motion Sickness and Nausea |
10 | — |
| SECONDARY Feasibility of Enrollment |
10 | — |
| SECONDARY Acceptability of Treatment |
10 | — |
| SECONDARY Adherence to Pain Surveys |
8 | — |
| SECONDARY Feasibility of Outcome Assessments |
10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Outpatient adults in the Level 1 Trauma Center
- Age 18 or older
- Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation
- Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase).
- Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40
- Has access to internet (Wi-Fi or wireless)
- Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for >6 weeks
- Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for >6 weeks)
- Cleared by orthopedic surgeon for study participation
Exclusion Criteria
- Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR
- Medical condition predisposing to nausea or dizziness.
- Hypersensitivity to flashing light or motion.
- Vision or severe hearing impairment.
- Injury to eyes, face, or neck that impedes comfortable use of virtual reality
- Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy)
- Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery)
- Current or prior untreated mental illness, substance use disorder, or suicidal ideation
- Self-reported pregnancy
- Currently in litigation or under Workman's Comp
- Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months
Data sourced from ClinicalTrials.gov (NCT05552430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.