Clinical trial NCT04548635: VR for Burn Dressing Changes at Home
Official title: Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burns
Acute Pain
Procedural Pain
Keywords: Virtual Reality
VR
Burns
Pain
Dressing Changes
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio Department of Public Safety
First posted: 2020-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain assessment during dressing changes.
timeFrame: 15-30 minutes during daily burn dressing changes for up to 7 days.
measure: Observed VR experience.
timeFrame: Daily for 15-30 minutes burn dressing change for up to 7 days.
measure: Self-reported VR experience.
timeFrame: Daily for 15-30 minutes burn dressing change for up to 7 days.
Secondary outcomes:
measure: Burn-related medications
timeFrame: Daily for burn dressing change for up to 7 days.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.