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Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Seattle Cancer and Aging Program
Information provided by (Responsible Party):
Chris Hoffer, University of Washington
ClinicalTrials.gov Identifier:
NCT00701571
First received: June 17, 2008
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: Chris Hoffer, Research Coordinator, University of Washington
ClinicalTrials.gov Identifier: NCT00701571     History of Changes
Other Study ID Numbers: 26745, 1R21CA107256-01A1, P20-CA103728-04
Study First Received: June 17, 2008
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Virtual Reality
Oncology
Lumbar puncture

ClinicalTrials.gov processed this record on June 17, 2013