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Virtual Reality in Burn Pain Management

Primary Purpose

Burns, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain management
Standard of care/no virtual reality game
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring wound care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or oler with thermal injury
  • Understands English
  • patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
  • ability to use a computer mouse or hit the space bar on a computer keyboard

Exclusion Criteria:

  • unhealed burned wounds on face, neck or head
  • history of severe susceptibility to motion sickness
  • presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
  • patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet

Sites / Locations

  • USAISR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Standard of care pain management

SnoWorld Virtual Reality Game

Outcomes

Primary Outcome Measures

There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
February 25, 2013
Sponsor
United States Army Institute of Surgical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00593086
Brief Title
Virtual Reality in Burn Pain Management
Official Title
The Use of Virtual Reality Video Games to Control Procedural Pain During Burn Wound Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.
Detailed Description
This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Pain
Keywords
wound care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Standard of care pain management
Arm Title
B
Arm Type
Experimental
Arm Description
SnoWorld Virtual Reality Game
Intervention Type
Procedure
Intervention Name(s)
Pain management
Other Intervention Name(s)
Snow World or Standard of care
Intervention Description
Pain mamagement for burn care procedures.
Intervention Type
Other
Intervention Name(s)
Standard of care/no virtual reality game
Other Intervention Name(s)
Standard of care
Intervention Description
no intervention for standard of care
Primary Outcome Measure Information:
Title
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or oler with thermal injury Understands English patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced ability to use a computer mouse or hit the space bar on a computer keyboard Exclusion Criteria: unhealed burned wounds on face, neck or head history of severe susceptibility to motion sickness presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Maani, MD
Organizational Affiliation
United States Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
USAISR
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15376608
Citation
Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. doi: 10.1080/00029157.2004.10401474. No abstract available.
Results Reference
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Virtual Reality in Burn Pain Management

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