NCT00593086

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

December 26, 2007

Last Update Submit

February 25, 2013

Conditions

BurnsPain

Keywords

wound care

Outcome Measures

Primary Outcomes (1)

  • There will be a 20-50% reduction in pain while using Virtual Reality Games during burn wound care

    48 hours

Study Arms (2)

A

ACTIVE COMPARATOR

Standard of care pain management

Procedure: Pain managementOther: Standard of care/no virtual reality game

B

EXPERIMENTAL

SnoWorld Virtual Reality Game

Procedure: Pain management

Interventions

Pain managementPROCEDURE

Pain mamagement for burn care procedures.

Also known as: Snow World or Standard of care
AB
Standard of care/no virtual reality gameOTHER

no intervention for standard of care

Also known as: Standard of care
A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAISR

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • 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.

    PMID: 15376608BACKGROUND

MeSH Terms

Conditions

BurnsPain

Interventions

Pain ManagementStandard of Care

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDisease ManagementPatient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Christopher Maani, MD

    United States Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 14, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2010

Study Completion

June 1, 2012

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)