Reducing Brief Thermal and Electrical Pain (Four Study Days)

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Virtual Reality video distraction; Other: Virtual Reality video game

• Registration Number: NCT00682682
• Lead Sponsor: University of Washington

Brief Summary

Ultimately, the purpose of the present study is to help improve pain control in burn patients during wound care and physical therapy, where pain levels with opioids alone are often excessively high.

This study measures how much virtual reality pain distraction reduces pain compared to traditional opioid pain meds, and whether there is additional pain reduction when Virtual Reality distraction + Opioids are combined. In addition to studying the amount of pain reduction, this study will also measure side effects (if any) of the two treatments (Virtual Reality pain distraction and Opioids) alone and when combined.

Healthy volunteers will be recruited from advertisements will undergo a trial of the pain testing. They will receive a series of brief stimuli (at a painful but tolerable safe intensities they select and approve during baseline testing), separated by intervals of no pain.

Participants will rate how much pain they felt after each brief stimulus, and will fill out side effects questionnaires after finishing the pain session.

Subjects will participate in each of the four conditions in which the order is randomized.

* No opioids (0ng/ml hydromorphone) + no virtual reality Snow World distraction

* No opioids + yes virtual reality Snow World distraction

* Moderate dose of pain medicine (4ng/ml hydromorphone) + no virtual reality

* Moderate dose of pain medicine + yes virtual reality Snow World distraction

It is our hypothesis that VR distraction + opioids will show a reduced perception of pain in subjects more than opioids alone or no intervention (control).

Detailed Description

In this study, healthy volunteers aged 18-45 who sign up after seeing a flyer or web posting are screened for exclusion via telephone interview, and if eligible, a health background interview. Initial contact will come from the subject's response to recruitment materials. Subjects may withdraw at any time.

These safe laboratory studies with healthy volunteers are designed to help us figure out how to maximize the effectiveness of virtual reality when used with severe burn patients at Harborview Burn Center

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Study Completion: 2008-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-12
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy men and women 18-45 years old
• Normal height and weight ratio

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Exclusion Criteria

• women who are pregnant and nursing
• history of substance abuse
• access to opioids in the workplace
• smokes cigarettes
• history of medical problems with the following: heart, lungs, liver, kidneys, endocrine, neurologic, migraines, or psychiatric requiring medical intervention
• anemia
• chronic pain
• allergy or hypersensitivity to opioids, velcro, or latex
• severe motion sickness
• unusual sensitivity or lack of sensitivity to pain
• sensitive skin or feet

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Virtual Reality video distraction	all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid
1	Virtual Reality video game	all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid

Primary Outcome Measures

Name	Time	Method
Efficacy of VR distraction with and without opioid when pain stimulus is applied.	at completion of study

Trial Locations

Locations (1)

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