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VR-PAT During Home Burn Dressings - Multisite

Primary Purpose

Burns, Acute Pain, Procedural Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR-PAT
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Virtual Reality, VR, Burns, Pain

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being treated for acute burn injury Age 6-17 years, inclusive Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient) Patient and family caregivers can communicate (read and write) using English or Spanish Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change. Exclusion Criteria: Any wounds that may interfere with study procedures 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, prisoners, or currently pregnant Suspected child abuse Families who do not have access to a VR compatible smartphone.

Sites / Locations

  • Nationwide Children's Hospital
  • Parkland Health & Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants will be using the VR-PAT during burn dressings.

Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).

Outcomes

Primary Outcome Measures

Change in self-reported pain
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.

Secondary Outcome Measures

Self-reported VR experience
0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.

Full Information

First Posted
December 21, 2022
Last Updated
January 30, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Parkland Health and Hospital System, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05673551
Brief Title
VR-PAT During Home Burn Dressings - Multisite
Official Title
A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Parkland Health and Hospital System, Agency for Healthcare Research and Quality (AHRQ)

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 effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.
Detailed Description
In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants 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, Injuries, Pediatric ALL
Keywords
Virtual Reality, VR, Burns, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will be using the VR-PAT during burn dressings.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).
Intervention Type
Other
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
Change in self-reported pain
Description
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
Time Frame
Immediately following each dressing change for one week
Secondary Outcome Measure Information:
Title
Self-reported VR experience
Description
0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.
Time Frame
Immediately following each dressing change for one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being treated for acute burn injury Age 6-17 years, inclusive Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient) Patient and family caregivers can communicate (read and write) using English or Spanish Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change. Exclusion Criteria: Any wounds that may interfere with study procedures 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, prisoners, or currently pregnant Suspected child abuse Families who do not have access to a VR compatible smartphone.
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Parkland Health & Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VR-PAT During Home Burn Dressings - Multisite

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