Virtual Reality for Burn Wound Care Pain Control - Tabular View

Tracking Information

First Received Date ^ICMJE

April 17, 2008

Last Updated Date

April 30, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Virtual Reality for Burn Wound Care Pain Control

Official Title ^ICMJE

Virtual Reality for Burn Wound Care Pain Control

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain
Anxiety

Intervention ^ICMJE

Other: Virtual Reality

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00663013

Responsible Party

R. W Yurt, MD,FACS, NewYork-Presbyterian Hospital-Weill Cornell Medical College

Study ID Numbers ^ICMJE

0701008961

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roger W Yurt, MD FACS

Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP