VR-PAT During Home Burn Dressings - Multisite (NCT05673551) | Clinical Trial Compass
By InvitationNot Applicable
VR-PAT During Home Burn Dressings - Multisite
United States220 participantsStarted 2023-01-16
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change in self-reported pain
Timeframe: Immediately following each dressing change for one week