Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

This study is currently recruiting participants.
Verified April 2013 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sam Sharar, University of Washington
ClinicalTrials.gov Identifier:
NCT01840774
First received: April 8, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Virtual Reality Therapy
Drug: Low-dose pain medication (Ketalar) and saline placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. [ Time Frame: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-dose pain medication
80min IV infusion of a low-dose pain medication
Drug: Low-dose pain medication (Ketalar) and saline placebo
Placebo Comparator: saline placebo
80min IV infusion of a saline placebo
Drug: Low-dose pain medication (Ketalar) and saline placebo

Detailed Description:

This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840774

Contacts
Contact: Christine Hoffer, BA 206-616-3075 hoffer@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Christine Hoffer, BA    206-616-3075    hoffer@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Samuel Sharar, MD University of Washington
  More Information

No publications provided

Responsible Party: Sam Sharar, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01840774     History of Changes
Other Study ID Numbers: 43929
Study First Received: April 8, 2013
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014