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Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

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ClinicalTrials.gov Identifier: NCT01840774
Recruitment Status : Unknown
Verified April 2013 by Sam Sharar, University of Washington.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sam Sharar, University of Washington

Tracking Information
First Submitted Date  ICMJE April 8, 2013
First Posted Date  ICMJE April 26, 2013
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
Official Title  ICMJE Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Virtual Reality Therapy
Intervention  ICMJE Drug: Low-dose pain medication (Ketalar) and saline placebo
Study Arms  ICMJE
  • Active Comparator: Low-dose pain medication
    80min IV infusion of a low-dose pain medication
    Intervention: Drug: Low-dose pain medication (Ketalar) and saline placebo
  • Placebo Comparator: saline placebo
    80min IV infusion of a saline placebo
    Intervention: Drug: Low-dose pain medication (Ketalar) and saline placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 25, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840774
Other Study ID Numbers  ICMJE 43929
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sam Sharar, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Samuel Sharar, MD University of Washington
PRS Account University of Washington
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP