NCT05673551

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Dec 2027

First Submitted

Initial submission to the registry

December 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

December 21, 2022

Last Update Submit

June 16, 2025

Conditions

BurnsAcute PainProcedural PainInjuriesPediatric ALL

Keywords

Virtual RealityVRBurnsPain

Outcome Measures

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.

    Immediately following each dressing change for one week

Secondary Outcomes (1)

  • Self-reported VR experience

    Immediately following each dressing change for one week

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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).

Interventions

VR-PATOTHER

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

Also known as: Virtual Reality
Intervention Group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (2)

  • 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: 38630653BACKGROUND

  • 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: 40361220DERIVED

MeSH Terms

Conditions

BurnsAcute PainPain, ProceduralWounds and InjuriesPrecursor Cell Lymphoblastic Leukemia-LymphomaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Center Director

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 6, 2023

Study Start

January 16, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)