Back to resultsVR for Burn Dressing Changes at Home
Primary Purpose
Burns, Acute Pain, Procedural Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VR-PAT
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Virtual Reality, VR, Burns, Pain, Dressing Changes
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)
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VR-PAT
Control
Arm Description
Virtual Reality administered during burn dressing changes
Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).
Outcomes
Primary Outcome Measures
Pain assessment during dressing changes.
1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.
Observed VR experience.
caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.
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.
Secondary Outcome Measures
Burn-related medications
caregiver-reported name and dosage of medication provided for burn-related pain
Full Information
NCT ID
NCT04548635
First Posted
September 1, 2020
Last Updated
October 8, 2021
Sponsor
Nationwide Children's Hospital
Collaborators
Ohio Department of Public Safety
1. Study Identification
Unique Protocol Identification Number
NCT04548635
Brief Title
VR for Burn Dressing Changes at Home
Official Title
Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Ohio Department of Public Safety
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Acute Pain, Procedural Pain
Keywords
Virtual Reality, VR, Burns, Pain, Dressing Changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR-PAT
Arm Type
Experimental
Arm Description
Virtual Reality administered during burn dressing changes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed).
Intervention Type
Device
Intervention Name(s)
VR-PAT
Other Intervention Name(s)
Virtual Reality
Intervention Description
Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
Primary Outcome Measure Information:
Title
Pain assessment during dressing changes.
Description
1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.
Time Frame
15-30 minutes during daily burn dressing changes for up to 7 days.
Title
Observed VR experience.
Description
caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.
Time Frame
Daily for 15-30 minutes burn dressing change for up to 7 days.
Title
Self-reported VR experience.
Description
1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.
Time Frame
Daily for 15-30 minutes burn dressing change for up to 7 days.
Secondary Outcome Measure Information:
Title
Burn-related medications
Description
caregiver-reported name and dosage of medication provided for burn-related pain
Time Frame
Daily for burn dressing change for up to 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Xiang, MD, MPH, PhD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35982492
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.
Results Reference
derived
Learn more about this trial
VR for Burn Dressing Changes at Home
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