A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Burns
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Change in self-reported pain
- Status
- Enrolling By Invitation
- Last Updated
- 10 months ago
Overview
Brief Summary
This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.
Detailed Description
In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.
Investigators
Henry Xiang
Professor of Medicine and Center Director
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Being treated for acute burn injury
- •Age 6-17 years, inclusive
- •Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit
- •Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient)
- •Patient and family caregivers can communicate (read and write) using English or Spanish
- •Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change.
Exclusion Criteria
- •Any wounds that may interfere with study procedures
- •Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- •History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- •Minors in foster care, prisoners, or currently pregnant
- •Suspected child abuse
- •Families who do not have access to a VR compatible smartphone.
Outcomes
Primary Outcomes
Change in self-reported pain
Time Frame: Immediately following each dressing change for one week
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
Secondary Outcomes
- Self-reported VR experience(Immediately following each dressing change for one week)