VR High Tech Pain Control Burn Wound Care (VRH2O)

High Technology Pain Control During Burn Wound Care

Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.

Study Overview

• Status: Completed
• Conditions: Pain; Burn
• Intervention / Treatment: Behavioral: Virtual Reality Distraction; Behavioral: Audio (sound of nature); Behavioral: Control standard nurse wound care

Detailed Description

This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.

Subjects in all three groups will receive the following questionnaires:

Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington; Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 18 years
• Compliant and able to complete questionnaires
• No history of psychiatric disorder
• Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
• Able to communicate verbally
• English-speaking

Exclusion Criteria:

• Age less than 18 years
• Not capable of indicating pain intensity
• Not capable of filling out study measures
• Evidence of traumatic brain injury
• History of psychiatric disorder
• Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
• Unable to communicate orally
• Receiving prophylaxis for alcohol or drug withdrawal
• Developmental disability
• Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
• Non-English Speaking
• Extreme susceptibility to motion sickness
• Seizure history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Virtual Reality Distraction; The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.	Behavioral: Virtual Reality Distraction; The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.; Other Names: VRD
OTHER: Audio (sounds of nature); The subjects will listen to an audio recording called "Sounds of Nature" during their wound care. The nurse will be doing the wound care.	Behavioral: Audio (sound of nature); The subjects will listen to an audio recording called "Sounds of Nature" during their wound care.
OTHER: control standard nurse wound care; The subjects will receive their standard care during wound care. The nurse will be doing the wound care.	Behavioral: Control standard nurse wound care; The subjects will receive their standard care during wound care. The nurse will be doing the wound care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Pain" as measured by McGill Short Form Pain Questionnaire	Pain is being measured	up to an hour
"Pain" as measured by Nurse Graphic Rating Scale	Pain is being measured.	up to 3 hours
"Pain and anxiety" as measured by Graphic Rating Scale	Pain and anxiety is being measured	up to an hour

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: David R. Patterson, Ph.D., University fo Washington

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (ESTIMATE): April 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: VRD; Virtual Reality as Distraction during Procedure; Burn Wound Care
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 41673