VR for Pain Management During Adult Burn Dressing Change

Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change

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.

Study Overview

• Status: Completed
• Conditions: Pain; Burns
• Intervention / Treatment: Other: VR-based Pain Alleviation Tool (VR-PAT)

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active VR-PAT; Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes.	Other: VR-based Pain Alleviation Tool (VR-PAT); Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
Experimental: Passive VR-PAT; Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes.	Other: VR-based Pain Alleviation Tool (VR-PAT); Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
No Intervention: Standard Care Control; Standard care control group used regular distraction such as background music or no distraction.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.	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.	Each day during inpatient hospital stays up to 7 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient VR experience	Patient subjective virtual reality experience using a survey questionnaire (7 items about participant's experience with VR during burning dressing changes). Questions are a mixture of yes/no and a 100 Visual Analog Scale with 0 being "Not at All" and 100 being "Very Much"	Subjective experience during burn dressing change, on average lasting 15-45 minutes.
Nurse reported feasibility of VR in clinical burn wound care	Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".	Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes.

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Henry Xiang, MD, MPH, PhD, The Ohio State University/Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): November 24, 2019
• Study Completion (Actual): November 24, 2019

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 2018H0257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not allowed to share patient medical records data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No