VR-PAT During Home Burn Dressings - Multisite
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-PAT.
- Who it may be relevant to
- Registry conditions: Burns, Acute Pain, Procedural Pain, Injuries. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
Overview
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.
Interventions
- Other VR-PAT
Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
Primary outcome measures
- Change in self-reported pain [Time frame: Immediately following each dressing change for one week]
Secondary outcome measures (1)
- Self-reported VR experience [Time frame: Immediately following each dressing change 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Nationwide Children's Hospital — Columbus
- Parkland Health & Hospital System — Dallas
Publications
- 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. PMID 38630653
- Armstrong M, Price A, Coffey R, Noffsinger D, Thakkar RK, Fabia RB, Groner JI, Mandell S, Ni A, Xiang H. Smartphone virtual reality for pain management during pediatric burn care transition: study protocol for a randomized controlled trial. Trials. 2025 May 13;26(1):157. doi: 10.1186/s13063-025-08860-4. PMID 40361220
Identifiers
NCT: NCT05673551 · STUDY00002851