Virtual Reality Water Friendly Wound Care (H2OWC)

June 4, 2020 updated by: David Patterson, University of Washington

Water Friendly Virtual Reality for Burns

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than or equal to 8 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 8 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Virtual Reality
The subject is actively engaged in using virtual reality during a painful burn wound care session.
Behavioral: Active Virtual Reality
The subject is actively engaged in using virtual reality during a painful burn wound care session.
Experimental: Passive Virtual Reality
The subject is passively engaged in using virtual reality during a painful burn wound care session.
Behavioral: Passive Virtual Reality
The subject is passively engaged in using virtual reality during a painful burn wound care session.
No Intervention: Control
No intervention during the subject's standard wound care session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Time Frame: one time for the duration of one minute before the wound care
one time for the duration of one minute before the wound care
Pain. Pain is measured one time after a painful burn wound, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
Time Frame: one time for the duration of one minute after the wound care
one time for the duration of one minute after the wound care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)
University of Texas
National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: David R Patterson, Ph.D., University of Washington
  • Principal Investigator: David R Patterson, Ph. D., University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 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

Other Study ID Numbers

  • STUDY00002594
  • R01GM042725 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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