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VRH Pain Reduction During Burn Wound Care and Physical Therapy (VRH)

Primary Purpose

Burn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
using VR hypnosis/distraction and audio hypnosis
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 Hypnosis

Eligibility Criteria

7 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age greater than or equal to 7 years 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: Age less than 7 years Incapable of indicating subjective evaluation of pain Non-English-speaking Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness

Sites / Locations

  • University of Washington; Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Arm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures.

Arm two uses Virtual Reality distraction that is administered at times other than during burn care procedure to control for both for attention and high technology.

Arm three use Audio administered Hypnosis without the visual technology.

Outcomes

Primary Outcome Measures

we use GRS, VAS, McGill,and nurse GRS to measure the pain.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2005
Last Updated
May 6, 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
NCT00260221
Brief Title
VRH Pain Reduction During Burn Wound Care and Physical Therapy
Acronym
VRH
Official Title
Testing Interactions to Adjunctive Pain Control Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
November 2011 (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 Hypnosis to relief pain and anxiety for burn patients.
Detailed Description
The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Arm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures.
Arm Title
2
Arm Type
Experimental
Arm Description
Arm two uses Virtual Reality distraction that is administered at times other than during burn care procedure to control for both for attention and high technology.
Arm Title
3
Arm Type
Experimental
Arm Description
Arm three use Audio administered Hypnosis without the visual technology.
Intervention Type
Behavioral
Intervention Name(s)
using VR hypnosis/distraction and audio hypnosis
Intervention Description
a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
Primary Outcome Measure Information:
Title
we use GRS, VAS, McGill,and nurse GRS to measure the pain.
Time Frame
once a day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 7 years 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: Age less than 7 years Incapable of indicating subjective evaluation of pain Non-English-speaking Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness
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
14768967
Citation
Patterson DR, Tininenko JR, Schmidt AE, Sharar SR. Virtual reality hypnosis: a case report. Int J Clin Exp Hypn. 2004 Jan;52(1):27-38. doi: 10.1076/iceh.52.1.27.23925.
Results Reference
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VRH Pain Reduction During Burn Wound Care and Physical Therapy

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