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Virtual Reality Pain Control During Burn Wound Care (VRPT/H2O/RT)

Primary Purpose

Burn

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Distraction
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn focused on measuring Virtual Reality Distraction

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to complete subjective evaluations of pain English-speaking Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder Able to communicate orally Exclusion Criteria: Incapable of indicating subjective evaluation of pain Non-English-speaking Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness Reports having no problem with pain during wound care.

Sites / Locations

  • University of Washington; Harborview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Virtual Reality distraction

Outcomes

Primary Outcome Measures

We use GRS, McGill to measure the outcome.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2005
Last Updated
April 17, 2013
Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00261690
Brief Title
Virtual Reality Pain Control During Burn Wound Care
Acronym
VRPT/H2O/RT
Official Title
Use of Virtual Reality for Adjunctive Treatment of Burn Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Using Virtual Reality as a form of Distraction during Burn Care.
Detailed Description
The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
Virtual Reality Distraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Virtual Reality distraction
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Distraction
Intervention Description
Using virtual reality distraction during a procedure
Primary Outcome Measure Information:
Title
We use GRS, McGill to measure the outcome.
Time Frame
once a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to complete subjective evaluations of pain English-speaking Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder Able to communicate orally Exclusion Criteria: Incapable of indicating subjective evaluation of pain Non-English-speaking Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness Reports having no problem with pain during wound care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Patterson, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington; Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14724926
Citation
Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. doi: 10.1002/jclp.10244.
Results Reference
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Virtual Reality Pain Control During Burn Wound Care

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