Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Virtual Reality Therapy Clinical Trial

Official title:

Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01840774
• Other study ID #: 43929
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2013
• Last updated: April 25, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: University of Washington
• Contact: Christine Hoffer, BA
• Phone: 206-616-3075
• Email: hoffer[@]uw.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Virtual Reality Therapy

Intervention

Drug:
• Low-dose pain medication (Ketalar) and saline placebo

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No