Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

This study is ongoing, but not recruiting participants.

First Received: June 17, 2008 Last Updated: June 18, 2008 History of Changes

Sponsor:	University of Washington
Collaborators:	National Institutes of Health (NIH) Seattle Cancer and Aging Program
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00701571

Purpose

The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.

Condition	Intervention
Pain	Procedure: Virtual Reality distraction

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

Further study details as provided by University of Washington:

Primary Outcome Measures:

To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years). [ Time Frame: upon completion of data collection ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 3 cohorts: 18-21 years, 40-60 years, and older than 60 years	Procedure: Virtual Reality distraction Virtual Reality involves the participant wearing a helmet with sight and sound. the visual provided is a type of immersive video game, the game used is "Snow World". In some cases the participant will be exposed to 3D representation of the game, and in other cases a lower tech version with less immersive qualities.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy men and women
18-21y, 40-60y, or older than 60y

Exclusion Criteria:

a predisposition to motion sickness
unusual sensitivity or lack of sensitivity to pain
chronic pain
peripheral neuropathy
sensitive skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701571

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Seattle Cancer and Aging Program

Investigators

Principal Investigator:

Samuel R Sharar, MD

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Samuel R. Sharar, MD )
Study ID Numbers:	26745, 1R21CA107256-01A1, P20-CA103728-04
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701571 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Virtual Reality
Oncology
Lumbar puncture

ClinicalTrials.gov processed this record on February 08, 2010