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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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

Other trials in United States

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.

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 groups in NCT05673551
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants will be using the VR-PAT during burn dressings.
Receives: Other: VR-PAT
Control GroupNo interventionParticipants 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.

  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.

    Measured: Immediately following each dressing change for one week

Secondary outcomes (1)

  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.

  1. First posted6 Jan 2023
  2. Study start16 Jan 2023
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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)
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 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

Questions about this trial

What is this clinical trial studying?

A study testing VR-PAT in people with Burns and Acute Pain, run by Nationwide Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-reported pain (time frame: Immediately following each dressing change for one week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05673551, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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