VR-PAT During Home Burn Dressings - Multisite

Nationwide Children's Hospital

Status

Invitation-only

Conditions

Injuries

Pediatric ALL

Burns

Acute Pain

Procedural Pain

Treatments

Other: VR-PAT

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05673551

STUDY00002851

Details and patient eligibility

About

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.

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.