Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

NCT ID: NCT00701571

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

3 cohorts: 18-21 years, 40-60 years, and older than 60 years

Group Type EXPERIMENTAL

Virtual Reality distraction

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Seattle Cancer and Aging Program

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Chris Hoffer

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel R Sharar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1R21CA107256-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20CA103728-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

26745

Identifier Type: -

Identifier Source: org_study_id

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