- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663013
Virtual Reality for Burn Wound Care Pain Control
January 3, 2011 updated by: Weill Medical College of Cornell University
The investigators propose to study the effects of virtual reality (VR) on patients' pain perception during burn wound care.
Such variables include psychiatric diagnosis and standard pain coping (i.e.
pain catastophizer vs. non-pain catastrophizer).Aims: The investigators intend to evaluate the use of virtual reality in pain distraction for burn patients undergoing burn wound care.
To that end our aims are: 1) To determine if pain perception will be less during the portion of the procedure in which the patient is immersed in the VR session in comparison to the portion of wound care which will occur without VR immersion.
2) To determine if anticipatory anxiety will be less for the portion of wound care that includes the virtual reality in comparison to the portion without virtual reality.
3) To determine if current psychiatric diagnosis, especially acute stress disorder and depression, is related to higher pain perception and greater decrease in pain with the virtual reality distraction.
4) To determine if being a "pain catastrophizer" is related to higher pain perception and greater benefits from the
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
12
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 Contact
- Name: Roger W Yurt, MD FACS
- Phone Number: 2127465410
- Email: ryurt@med.cornell.edu
Study Contact Backup
- Name: Angela Rabbitts, RN MS
- Phone Number: 2127465881
- Email: anr2002@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- New York Presbyterian Hospital, WRH Burn Center
-
Contact:
- Roger W Yurt, MD FACS
- Phone Number: 212-746-5410
- Email: ryurt@med.cornell.edu
-
Principal Investigator:
- Roger W Yurt, MD FACS
-
-
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
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 12-100years
- Minimum burn wound size of 2% total body surface area (TBSA) excluding head and dominant hand
- Be able to sit upright independently in bed
- Minimum pain rating of 4/10 on a Visual Analog Scale (only using the most painful extremity).
- Able to consent to the study
Exclusion Criteria:
- Known history of motion sickness
- Seizures
- Migraines
- Current psychosis, dementia, or delirium
- Current blindness and/or deafness that significantly affects their ability to experience the VR
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
The first treatment session will involve 5-7 minutes of burn wound care while distracted by VR, and 5-7 minutes of burn wound care without the distraction of VR.
The second session of burn wound care (performed within the next 3 days) will involve 5-7 minutes of burn wound care without the distraction of VR, and 5-7 minutes of burn wound care with the distraction of VR.
The treatment order will be randomized.
|
Virtual reality (VR) gives patients an illusion of going into the 3-D computer generated environment/virtual world.
During VR, the subject wears a head-mounted virtual reality helmet that positions two goggle-sized miniature LCD computer screens close to the subject's eyes.
Position tracking devices keep the computer informed of changes in the patient's head location.
An electro-magnetic head orientation device feeds the x, y, z coordinates of the patient's head to the computer, which can quickly change what the patient sees in virtual reality accordingly.
The scenery in VR changes as the patient moves her head orientation (e.g., virtual objects in front of the patient in VR get closer as the patient, wearing the VR helmet, leans forward in the real world).
Other Names:
|
Active Comparator: 2
The first treatment session will involve 5-7 minutes of burn wound care while distracted by VR, and 5-7 minutes of burn wound care without the distraction of VR.
The second session of burn wound care (performed within the next 3 days) will involve 5-7 minutes of burn wound care without the distraction of VR, and 5-7 minutes of burn wound care with the distraction of VR.
The treatment order will be randomized.
|
Virtual reality (VR) gives patients an illusion of going into the 3-D computer generated environment/virtual world.
During VR, the subject wears a head-mounted virtual reality helmet that positions two goggle-sized miniature LCD computer screens close to the subject's eyes.
Position tracking devices keep the computer informed of changes in the patient's head location.
An electro-magnetic head orientation device feeds the x, y, z coordinates of the patient's head to the computer, which can quickly change what the patient sees in virtual reality accordingly.
The scenery in VR changes as the patient moves her head orientation (e.g., virtual objects in front of the patient in VR get closer as the patient, wearing the VR helmet, leans forward in the real world).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain perception
Time Frame: immediate
|
immediate
|
anticipatory anxiety
Time Frame: immediate
|
immediate
|
current psychiatric diagnosis, is related to pain
Time Frame: immediate
|
immediate
|
"pain catastrophizing" is related to higher pain perception and greater benefits from the VR
Time Frame: immediate
|
immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roger W Yurt, MD FACS, Weill Medical College of Cornell University
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
October 1, 2007
Primary Completion (Anticipated)
May 1, 2010
Study Completion (Anticipated)
May 1, 2010
Study Registration Dates
First Submitted
April 17, 2008
First Submitted That Met QC Criteria
April 19, 2008
First Posted (Estimate)
April 21, 2008
Study Record Updates
Last Update Posted (Estimate)
January 4, 2011
Last Update Submitted That Met QC Criteria
January 3, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0701008961
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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