VR-PAT During Home Burn Dressings - Multisite

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05673551

Collaborator

Parkland Health and Hospital System (Other), Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

220

Enrollment

Locations

Arms

58.5

Anticipated Duration (Months)

110

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burns Acute Pain Procedural Pain Injuries Pediatric ALL	Other: VR-PAT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

Actual Study Start Date :

Jan 16, 2023

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants will be using the VR-PAT during burn dressings.	Other: VR-PAT Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset Other Names: Virtual Reality
No Intervention: Control Group Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).

Arm

Intervention/Treatment

Experimental: Intervention Group

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

Other: VR-PAT

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

Other Names:

Virtual Reality

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

Change in self-reported pain [Immediately following each dressing change for one week]
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 [Immediately following each dressing change for one week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.