VR for Burn Dressing Changes at Home

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548635
• Other study ID #: STUDY00000450
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 5, 2019
• Est. completion date: June 18, 2021

Study information

• Verified date: April 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Burns
• Pain, Procedural
• Procedural Pain

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Ohio Department of Public Safety

Country where clinical trial is conducted

United States, 

References & 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Burn-related medications	caregiver-reported name and dosage of medication provided for burn-related pain	Daily for burn dressing change for up to 7 days.