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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00701571
Other study ID # 26745
Secondary ID 1R21CA107256-01A
Status Completed
Phase N/A
First received June 17, 2008
Last updated September 12, 2011
Start date September 2005
Est. completion date December 2009

Study information

Verified date September 2011
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington National Institutes of Health (NIH), Seattle Cancer and Aging Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). upon completion of data collection No
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