BurnsNCT05673551
VR-PAT During Home Burn Dressings - Multisite
A study testing VR-PAT in people with Burns and Acute Pain, run by Nationwide Children's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Burns, Acute Pain, Procedural Pain
- What is being tested?
- VR-PAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2023to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
Parkland Health & Hospital System
Dallas, Texas, 75235
About this study
Official title: A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
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.
Read the 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.
- Conditions
- Burns, Acute Pain, Procedural Pain, Injuries, Pediatric ALL
- Being tested
- VR-PAT
- Keywords
- Virtual Reality, VR, Burns, Pain
- Medical subject headings
- Burns, Acute Pain, Pain, Procedural, Wounds and Injuries, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-PATOther
Also called Virtual Reality
Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be using the VR-PAT during burn dressings. Receives: Other: VR-PAT |
| Control Group | No intervention | Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported pain
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.
Measured: Immediately following each dressing change for one week
Secondary outcomes (1)
Self-reported VR experience
0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.
Measured: Immediately following each dressing change for one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start16 Jan 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Parkland Health and Hospital System, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673551
- Sponsor's protocol ID
- STUDY00002851
- Status last verified
- Jul 2026
- First submitted
- 21 Dec 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38630653Armstrong 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.
PubMed 40361220