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VR for Pain Management During Adult Burn Dressing Change

Primary Purpose

Pain, Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR-based Pain Alleviation Tool (VR-PAT)
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Active VR-PAT

Passive VR-PAT

Standard Care Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Patient self-reported pain
Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2020
Last Updated
September 21, 2022
Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04545229
Brief Title
VR for Pain Management During Adult Burn Dressing Change
Official Title
Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 24, 2019 (Actual)
Study Completion Date
November 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-group RCT
Masking
None (Open Label)
Masking Description
In this pilot study, no masking was implemented.
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active VR-PAT
Arm Type
Experimental
Arm Description
Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes.
Arm Title
Passive VR-PAT
Arm Type
Experimental
Arm Description
Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes.
Arm Title
Standard Care Control
Arm Type
No Intervention
Arm Description
Standard care control group used regular distraction such as background music or no distraction.
Intervention Type
Other
Intervention Name(s)
VR-based Pain Alleviation Tool (VR-PAT)
Intervention Description
Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
Primary Outcome Measure Information:
Title
Patient self-reported pain
Description
Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome.
Time Frame
During burn dressing changes
Secondary Outcome Measure Information:
Title
Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.
Description
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.
Time Frame
Each day during inpatient hospital stays up to 7 days.
Other Pre-specified Outcome Measures:
Title
Patient VR experience
Description
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"
Time Frame
Subjective experience during burn dressing change, on average lasting 15-45 minutes.
Title
Nurse reported feasibility of VR in clinical burn wound care
Description
Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from "not at all" to "very easy".
Time Frame
Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Xiang, MD, MPH, PhD
Organizational Affiliation
The Ohio State University/Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not allowed to share patient medical records data.

Learn more about this trial

VR for Pain Management During Adult Burn Dressing Change

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