Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 26, 2013
April 1, 2013
1.2 years
April 8, 2013
April 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.
Study Arms (2)
Low-dose pain medication
ACTIVE COMPARATOR80min IV infusion of a low-dose pain medication
saline placebo
PLACEBO COMPARATOR80min IV infusion of a saline placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and females between the age of 18 and 60 years
- Ability to communicate orally
- Ability to read and understand English
- Body Mass Index between 20-35
You may not qualify if:
- Women who are pregnant, trying to become pregnant, or who are breastfeeding
- History of alcohol or substance abuse
- Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
- Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
- Predisposition to severe motion sickness
- Unusual sensitivity or lack of sensitivity to pain
- Urine toxicology positive for opioids or benzodiazepines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Sharar, MD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 26, 2013
Study Start
April 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 26, 2013
Record last verified: 2013-04