Pain Clinical Trial
Official title:
Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
| 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 |
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.
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington | National Institutes of Health (NIH), Seattle Cancer and Aging Program |
United States,
| 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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