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Enrolling by invitationNCT05673551Updated Jul 31, 2026

VR-PAT During Home Burn Dressings - Multisite

An interventional study of VR-PAT in Burns, Acute Pain and Procedural Pain, sponsored by Nationwide Children's Hospital. Enrolling by invitation at 2 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Burns
  • Acute Pain
  • Procedural Pain
  • Injuries
  • Pediatric ALL

Keywords

  • Virtual Reality
  • VR
  • Burns
  • Pain
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 220 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Participants will be using the VR-PAT during burn dressings.

    Other: VR-PAT

  • No intervention
    Control Group

    Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).

Interventions

  • OtherVR-PAT

    Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset

    Also known as: Virtual Reality

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Immediately following each dressing change for one week

07

Study locations

2 sites
08

References and documents

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 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. PubMed 40361220 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Dec 2027, 58 months after the start.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 58 months is above that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2022
First posted
Jan 6, 2023
StartActual
Jan 16, 2023
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05673551
Collaborators
Parkland Health and Hospital System, Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Henry Xiang (Professor of Medicine and Center Director, Nationwide Children's Hospital) — Principal investigator
First posted
Jan 6, 2023
Start date
Jan 16, 2023
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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