Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain

This study has been completed.
Sponsor:
Collaborators:
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
  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
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 April 15, 2014