Virtual Reality in Burn Pain Management

NCT ID: NCT00593086

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-06-30

Brief Summary

To examine the safety and efficacy of Virtual Reality (VR) distraction therapy in burn patients experiencing severe procedural pain during wound care.

Detailed Description

This is a prospective, randomized cross-over study of the safety and effectiveness of the use of a virtual reality distraction intervention to management procedural pain during burn wound care. Up to 20 subjects will be enrolled until 12 complete the study.

Conditions

Burns; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Standard of care pain management

Group Type: ACTIVE_COMPARATOR

Pain management

Intervention Type: PROCEDURE

Pain mamagement for burn care procedures.

Standard of care/no virtual reality game

Intervention Type: OTHER

no intervention for standard of care

B

SnoWorld Virtual Reality Game

Group Type: EXPERIMENTAL

Pain management

Intervention Type: PROCEDURE

Pain mamagement for burn care procedures.

Interventions

Pain management

Pain mamagement for burn care procedures.

Intervention Type: PROCEDURE

Standard of care/no virtual reality game

no intervention for standard of care

Intervention Type: OTHER

Other Intervention Names

Snow World or Standard of care; Standard of care

Eligibility Criteria

Inclusion Criteria

• 18 years or oler with thermal injury
• Understands English
• patient perception of previous wound care procedural pain is greater than 6 on a numeric pain scal of 0-10 where 0= no pain and 10=worst pain ever experienced
• ability to use a computer mouse or hit the space bar on a computer keyboard

Exclusion Criteria

• unhealed burned wounds on face, neck or head
• history of severe susceptibility to motion sickness
• presence of open woun ds to the hands that cannot be covered with a dressing while operating the control button
• patients who report a feeling of anxiety or discomfort while viewing the Snow World software on a computer without the helmet

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Maani, MD

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

USAISR

Fort Sam Houston, Texas, United States

Countries

United States

References

Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. doi: 10.1080/00029157.2004.10401474. No abstract available.

Reference Type: BACKGROUND

PMID: 15376608 (View on PubMed)

Other Identifiers

H-06-024

Identifier Type: -

Identifier Source: org_study_id