Clinical trial · Interventional
VR-PAT During Home Burn Dressings - Multisite
A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
NCT05673551CI-TRIAL-00120064enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Burns | — | UNRESOLVED | — |
| Injuries | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Procedural Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VR-PAT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participants will be using the VR-PAT during burn dressings.
- interventionNames
- Other: VR-PAT
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).
Primary outcomes (1)
- measure
- Change in self-reported pain
- timeFrame
- Immediately following each dressing change for one week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDLu 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
- DERIVEDArmstrong 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