VR for Pain Management During Adult Burn Dressing Change

NCT04545229 | Completed

• 1 other identifier: 2018H0257
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.

  Each day during inpatient hospital stays up to 7 days.

Other Outcomes (2)

• Patient VR experience

  Subjective experience during burn dressing change, on average lasting 15-45 minutes.

• Nurse reported feasibility of VR in clinical burn wound care

  Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes.

Study Arms (3)

Active VR-PAT

EXPERIMENTAL

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)

Passive VR-PAT

EXPERIMENTAL

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)

Standard Care Control

NO INTERVENTION

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

Interventions

VR-based Pain Alleviation Tool (VR-PAT) OTHER

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

Active VR-PAT; Passive VR-PAT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio State University: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• 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.

  PMID: 37747893 RESULT

MeSH Terms

Conditions

Pain; Burns

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Henry Xiang, MD, MPH, PhD

  The Ohio State University/Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this pilot study, no masking was implemented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Center Director

Model Details: Three-group RCT

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 10, 2020
• Study Start: February 1, 2019
• Primary Completion: November 24, 2019
• Study Completion: November 24, 2019
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)