- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260221
VRH Pain Reduction During Burn Wound Care and Physical Therapy (VRH)
May 6, 2013 updated by: David R. Patterson, National Institute of General Medical Sciences (NIGMS)
Testing Interactions to Adjunctive Pain Control Techniques
Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
77
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
-
-
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
7 years to 85 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
Arm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures.
|
a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
|
|
EXPERIMENTAL: 2
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.
|
a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
|
|
EXPERIMENTAL: 3
Arm three use Audio administered Hypnosis without the visual technology.
|
a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
we use GRS, VAS, McGill,and nurse GRS to measure the pain.
Time Frame: once a day
|
once a day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2002
Primary Completion (ACTUAL)
January 1, 2011
Study Completion (ACTUAL)
November 1, 2011
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (ESTIMATE)
December 1, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 8, 2013
Last Update Submitted That Met QC Criteria
May 6, 2013
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19635-B
- 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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