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OpenTrials
Completed

NCT Number: NCT04548635

VR for Burn Dressing Changes at Home

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.

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Key information

Conditions

Burns Acute Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Pain Signs and Symptoms Wounds and Injuries

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VR-PAT

Device

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

Other names: Virtual Reality

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Burn-related medications

    Time frame: Daily for burn dressing change for up to 7 days.

    caregiver-reported name and dosage of medication provided for burn-related pain

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Ohio Department of Public Safety

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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