Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Not Applicable

• Conditions: Virtual Reality Therapy
• Interventions: Drug: Low-dose pain medication (Ketalar) and saline placebo

• Registration Number: NCT01840774
• Lead Sponsor: University of Washington

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 Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-25
• Last Update Submitted: 2013-04-25
• Study First Posted: 2013-04-26
• Last Update Posted: 2013-04-26
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-dose pain medication	Low-dose pain medication (Ketalar) and saline placebo	80min IV infusion of a low-dose pain medication
saline placebo	Low-dose pain medication (Ketalar) and saline placebo	80min IV infusion of a saline placebo

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States