Virtual Reality for Burn Wound Care Pain Control

Pain Clinical Trial

Official title:

Virtual Reality for Burn Wound Care Pain Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00663013
• Other study ID #: 0701008961
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2008
• Last updated: January 3, 2011
• Start date: October 2007
• Est. completion date: May 2010

Study information

• Verified date: January 2011
• Source: Weill Medical College of Cornell University
• Contact: Roger W Yurt, MD FACS
• Phone: 2127465410
• Email: ryurt[@]med.cornell.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

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).

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital, WRH Burn Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain perception		immediate	No
Primary	anticipatory anxiety		immediate	No
Primary	current psychiatric diagnosis, is related to pain		immediate	No
Primary	"pain catastrophizing" is related to higher pain perception and greater benefits from the VR		immediate	No