ClinicalTrials.gov
ClinicalTrials.gov Menu

Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00701571
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : September 13, 2011
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Seattle Cancer and Aging Program
Information provided by (Responsible Party):
Chris Hoffer, University of Washington

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Procedure: Virtual Reality distraction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
Study Start Date : September 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chris Hoffer, Research Coordinator, University of Washington
ClinicalTrials.gov Identifier: NCT00701571     History of Changes
Other Study ID Numbers: 26745
1R21CA107256-01A1 ( U.S. NIH Grant/Contract )
P20CA103728-04 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

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