Virtual Reality in Burn Pain Management | NCT00593086

Studies
Virtual Reality in Burn Pain Management

NCT00593086

Sponsor

United States Army Institute of Surgical Research

Status

Completed

Last Update Posted

Feb 27, 2013Estimated

Enrollment

26Actual

Phase

Not Applicable

Conditions

Burns
Pain

Interventions

Pain management
Standard of care/no virtual reality game

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Jun 2012Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2013

Last Update Posted Date

Feb 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Standard of care pain management	Procedure: Pain management Other: Standard of care/no virtual reality game
B	Experimental	SnoWorld Virtual Reality Game	Procedure: Pain management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain management	Procedure	Pain mamagement for burn care procedures.	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care		48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Maani, MD	United States Army Institute of Surgical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
USAISR		Fort Sam Houston	Texas	78234	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15376608	Background	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.

ID	Term
D014947	Wounds and Injuries
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D059408	Pain Management
D059039	Standard of Care

ID	Term
D013812	Therapeutics
D019468	Disease Management
D010346	Patient Care Management
D006298	Health Services Administration

ID	Term
D002056	Burns
D010146	Pain