NCT00663013

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

2.6 years

First QC Date

April 17, 2008

Last Update Submit

January 3, 2011

Conditions

Keywords

burnpainanxiety

Outcome Measures

Primary Outcomes (4)

  • pain perception

    immediate

  • anticipatory anxiety

    immediate

  • current psychiatric diagnosis, is related to pain

    immediate

  • "pain catastrophizing" is related to higher pain perception and greater benefits from the VR

    immediate

Study Arms (2)

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

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

Interventions

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).

Also known as: SnowWorld Multigen-Paradigm Inc, SimWright Inc
12

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital, WRH Burn Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

PainAnxiety DisordersBurns

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersWounds and Injuries

Study Officials

  • Roger W Yurt, MD FACS

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger W Yurt, MD FACS

CONTACT

Angela Rabbitts, RN MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

October 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations