VR for Pain Management During Adult Burn Dressing Change

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545229
• Other study ID #: 2018H0257
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 24, 2019

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 24, 2019
• Est. primary completion date: November 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Ohio State University

Country where clinical trial is conducted

United States, 

References & 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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	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.