Virtual Reality Pain Control During Burn Wound Care | NCT00261690

Studies
Virtual Reality Pain Control During Burn Wound Care

NCT00261690

Sponsor

National Institute of General Medical Sciences (NIGMS)

Status

Completed

Last Update Posted

Apr 19, 2013Estimated

Enrollment

184Actual

Phase

Phase 2Phase 3

Conditions

Burn

Interventions

Virtual Reality Distraction

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

ID	Type	Description	Link
R01GM042725	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2012

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

Feb 2002

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Dec 2, 2005

First Submission Date that Met QC Criteria

Dec 2, 2005

First Posted Date

Dec 5, 2005Estimated

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

Apr 17, 2013

Last Update Posted Date

Apr 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David R. Patterson, PhD, ABPP. Professor, National Institute of General Medical Sciences (NIGMS)Principal Investigator

Lead Sponsor

National Institute of General Medical Sciences (NIGMS)NIH

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH

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

Using Virtual Reality as a form of Distraction during Burn Care.

Detailed Description

The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Virtual Reality distraction	Behavioral: Virtual Reality Distraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality Distraction	Behavioral	Using virtual reality distraction during a procedure	1

Measure	Description	Time Frame
We use GRS, McGill to measure the outcome.		once a day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to complete subjective evaluations of pain
English-speaking
Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
Able to communicate orally

Exclusion Criteria:

Incapable of indicating subjective evaluation of pain
Non-English-speaking
Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet
Demonstrating delirium, psychosis, or Organic Brain Disorder
Unable to communicate verbally
Significant developmental disability
Extreme susceptibility to motion sickness
Reports having no problem with pain during wound care.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R. Patterson, Ph.D.	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington; Harborview Medical Center		Seattle	Washington	98104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14724926	Background	Hoffman HG, Patterson DR, Magula J, Carrougher GJ, Zeltzer K, Dagadakis S, Sharar SR. Water-friendly virtual reality pain control during wound care. J Clin Psychol. 2004 Feb;60(2):189-95. doi: 10.1002/jclp.10244.