VR for Pain Management During Adult Burn Dressing Change

Not Applicable

Completed

• Conditions: Pain; Burns
• Interventions: Other: VR-based Pain Alleviation Tool (VR-PAT)

• Registration Number: NCT04545229
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.

Detailed Description

A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group will receive VR-PAT as a distraction tool during the dressing change procedure (active VR group) while the comparison groups will receive either a comparable passive VR distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (Control Group 1), or no distraction at all (Control Group 2).

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-11-24
• Study Completion: 2019-11-24
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Adult burn patient age 18-70
2. First admission for acute burn requiring dressing change
3. First admission for burn injury
4. Using Opioids for dressing changes
5. Burn is ≤ 4 days post burn

Exclusion Criteria

1. Severe burn(s) on the face/head preventing utilization of VR
2. Cognitive/motor impairment preventing valid administration of study measures
3. Unable to communicate in English
4. Prisoners and patients who were pregnant
5. Patients admitted to the ICU

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active VR-PAT	VR-based Pain Alleviation Tool (VR-PAT)	Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes.
Passive VR-PAT	VR-based Pain Alleviation Tool (VR-PAT)	Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes.

Primary Outcome Measures

Name	Time	Method
Patient self-reported pain	During burn dressing changes	Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.

Secondary Outcome Measures

Name	Time	Method
Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.	Each day during inpatient hospital stays up to 7 days.	Opioid pain medication use (converted to morphine equivalent dose), obtained through patient medical administration records. This data will be used as morphine equivalent dose per day, total morphine-equivalent dose during hospital stay, and average morphine-equivalent dose among active VR group, passive VR group, and standard care group in comparison.

Trial Locations

Locations (1)

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