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Clinical Trials/NCT04548635
NCT04548635
Completed
Phase 2

Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management

Nationwide Children's Hospital1 site in 1 country36 target enrollmentSeptember 5, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Burns
Sponsor
Nationwide Children's Hospital
Enrollment
36
Locations
1
Primary Endpoint
Self-reported VR experience.
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects 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.

Registry
clinicaltrials.gov
Start Date
September 5, 2019
End Date
June 18, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henry Xiang

Professor and Center Director

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Self-reported VR experience.

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

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

Pain assessment during dressing changes.

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

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

Observed VR experience.

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

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

Secondary Outcomes

  • Burn-related medications(Daily for burn dressing change for up to 7 days.)

Study Sites (1)

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