VR-PAT During Home Burn Dressings - Multisite

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05673551
• Other study ID #: STUDY00002851
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 220
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Burns
• Injuries
• Pain, Procedural
• Pediatric ALL
• Procedural Pain

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Agency for Healthcare Research and Quality (AHRQ), Parkland Health and Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately following each dressing change for one week
Secondary	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.	Immediately following each dressing change for one week