Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

April 25, 2013 updated by: Sam Sharar, University of Washington
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Christine Hoffer, BA
          • Phone Number: 206-616-3075
          • Email: hoffer@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Samuel Sharar, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (ESTIMATE)

April 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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