VR-PAT During Home Burn Dressings - Multisite

Not Applicable

• Conditions: Injuries; Pediatric ALL; Procedural Pain; Burns; Acute Pain
• Interventions: Other: VR-PAT

• Registration Number: NCT05673551
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-06
• Study Start: 2023-01-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 220

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States