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H2OWC: Virtual Reality Water Friendly Wound Care

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02646787
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of General Medical Sciences (NIGMS) (NIH), University of Texas (Other)
56
Enrollment
1
Location
3
Arms
56
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Active Virtual Reality
  • Behavioral: Passive Virtual Reality
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Water Friendly Virtual Reality for Burns
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. [one time for the duration of one minute before the wound care]

  2. 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. [one time for the duration of one minute after the wound care]

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington; Harborview Medical Center Seattle Washington United States 98104

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Patterson, Professor, School of Medicine, Rehabilitation Medicine:Psychology, University of Washington
ClinicalTrials.gov Identifier:
NCT02646787
Other Study ID Numbers:
  • STUDY00002594
  • R01GM042725
First Posted:
Jan 6, 2016
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020

Study Results

No Results Posted as of Jun 9, 2020