Virtual Reality for Burn Wound Care Pain Control - Full Text View

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00663013

Purpose

We 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: We 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

Condition	Intervention
Pain Anxiety	Other: Virtual Reality

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Virtual Reality for Burn Wound Care Pain Control

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

pain perception [ Time Frame: immediate ] [ Designated as safety issue: No ]
anticipatory anxiety [ Time Frame: immediate ] [ Designated as safety issue: No ]
current psychiatric diagnosis, is related to pain [ Time Frame: immediate ] [ Designated as safety issue: No ]
"pain catastrophizing" is related to higher pain perception and greater benefits from the VR [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Other: Virtual Reality 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).
2: Active Comparator 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.	Other: Virtual Reality 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).

Arms

Assigned Interventions

1: Active Comparator

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.

Other: Virtual Reality

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).

2: Active Comparator

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.

Other: Virtual Reality

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).

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663013

Contacts

Contact: Roger W Yurt, MD FACS	2127465410	ryurt@med.cornell.edu
Contact: Angela Rabbitts, RN MS	2127465881	anr2002@med.cornell.edu

Locations

United States, New York
New York Presbyterian Hospital, WRH Burn Center	Recruiting
New York, New York, United States, 10065
Contact: Roger W Yurt, MD FACS 212-746-5410 ryurt@med.cornell.edu
Principal Investigator: Roger W Yurt, MD FACS

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Roger W Yurt, MD FACS

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	NewYork-Presbyterian Hospital-Weill Cornell Medical College ( R. W Yurt, MD,FACS )
Study ID Numbers:	0701008961
Study First Received:	April 17, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00663013 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

burn
pain
anxiety

ClinicalTrials.gov processed this record on November 30, 2009