Reducing Brief Thermal and Electrical Pain (Four Study Days)

Study Overview
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Brief Summary
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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
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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

Official Title
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Reducing Brief Thermal and Electrical Pain (Four Study Days)

Conditions
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Pain

Intervention / Treatment
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* Other: Virtual Reality video distraction
* Other: Virtual Reality video game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women 18-45 years old Normal height and weight ratio 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>all study participants will have 4 visits: VR alone, VR + opioid, opioid alone, and no VR/opioid | Other: Virtual Reality video distraction<br>* Virtual Reality involves wearing a helmet and playing a game called Snow world. This game has sound and is presented in 3D format. This game has immersive qualities that help user feel as if they are in the game.<br>Other: Virtual Reality video game<br>* Virtual Reality video games involve wearing a helmet with vision and sound. this game is presented in 3D which gives the user the feeling of being in the game. The game used for this study is Snow World<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of VR distraction with and without opioid when pain stimulus is applied. |  | at completion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain distraction, Analgesic interventions, Burn patients