VR for Pain Management During Adult Burn Dressing Change

NCT ID: NCT04545229

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-11-24

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).

Conditions

Pain; Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active VR-PAT

Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes.

Group Type: EXPERIMENTAL

VR-based Pain Alleviation Tool (VR-PAT)

Intervention Type: OTHER

Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.

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.

Group Type: EXPERIMENTAL

VR-based Pain Alleviation Tool (VR-PAT)

Intervention Type: OTHER

Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.

Standard Care Control

Standard care control group used regular distraction such as background music or no distraction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henry Xiang

Professor and Center Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Xiang, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University/Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

Armstrong M, Coffey R, Luna J, Xiang H. Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned. PLOS Digit Health. 2023 Sep 25;2(9):e0000231. doi: 10.1371/journal.pdig.0000231. eCollection 2023 Sep.

Reference Type: RESULT

PMID: 37747893 (View on PubMed)

Other Identifiers

2018H0257

Identifier Type: -

Identifier Source: org_study_id