H2O VR for Burns 2015 (H2OWC)

Water Friendly Virtual Reality for Burns

This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

Study Overview

• Status: Completed
• Conditions: Pain; Burn
• Intervention / Treatment: Behavioral: Control standard nurse wound care; Behavioral: Virtual Reality Snowworld; Behavioral: Virtual Reality slides of nature

Detailed Description

This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• 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 Snowworld; The subjects will receive Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.	Behavioral: Virtual Reality Snowworld; The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.
OTHER: Virtual Reality slides of nature; The subjects will see several slides of the nature through virtual reality goggles during their wound care. The nurse will be doing the wound care.	Behavioral: Virtual Reality slides of nature; The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing 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 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)
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (ESTIMATE): April 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: VRD
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 50416EB/002594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO