NCT04548635

Brief Summary

This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 5, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

September 1, 2020

Last Update Submit

April 29, 2024

Conditions

BurnsAcute PainProcedural Pain

Keywords

Virtual RealityVRBurnsPainDressing Changes

Outcome Measures

Primary Outcomes (3)

  • Pain assessment during dressing changes.

    1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.

    15-30 minutes during daily burn dressing changes for up to 7 days.

  • Observed VR experience.

    caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.

    Daily for 15-30 minutes burn dressing change for up to 7 days.

  • Self-reported VR experience.

    1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.

    Daily for 15-30 minutes burn dressing change for up to 7 days.

Secondary Outcomes (1)

  • Burn-related medications

    Daily for burn dressing change for up to 7 days.

Study Arms (2)

VR-PAT

EXPERIMENTAL

Virtual Reality administered during burn dressing changes

Device: VR-PAT

Control

NO INTERVENTION

Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).

Interventions

VR-PATDEVICE

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

Also known as: Virtual Reality
VR-PAT

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients age 5-17 years (inclusive)
  • receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
  • have a dressing that requires daily changes at home for at least one week
  • can communicate orally

You may not qualify if:

  • any wounds that may interfere with study procedures (i.e. face)
  • 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
  • suspected child abuse
  • unable to communicate in English
  • families who do not have access to a smartphone (due to the VR-PAT game requirements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.

    PMID: 35982492RESULT

MeSH Terms

Conditions

BurnsAcute PainPain, ProceduralPain

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henry Xiang, MD, MPH, PhD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Center Director

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 14, 2020

Study Start

September 5, 2019

Primary Completion

June 18, 2021

Study Completion

June 18, 2021

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)