Clinical trial NCT05673551: VR-PAT During Home Burn Dressings - Multisite
Official title: A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Burns
Acute Pain
Procedural Pain
Injuries
Pediatric ALL
Keywords: Virtual Reality
VR
Burns
Pain
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Parkland Health and Hospital System
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-01-06
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in self-reported pain
timeFrame: Immediately following each dressing change for one week
Secondary outcomes:
measure: Self-reported VR experience
timeFrame: Immediately following each dressing change for one week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
References:
citation: Lu A, Armstrong M, Alexander R, Vest E, Chang J, Zhu M, Xiang H. Trends in pediatric prescription-opioid overdoses in U.S. emergency departments from 2008-2020: An epidemiologic study of pediatric opioid overdose ED visits. PLoS One. 2024 Apr 17;19(4):e0299163. doi: 10.1371/journal.pone.0299163. eCollection 2024.