Evaluating VR Therapy Using Cold Pressor Test

Study Overview
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Brief Summary
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This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.

Official Title
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Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy

Conditions
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Pain

Intervention / Treatment
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* Device: Virtual Reality
* Other: Cold Pressor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult Mayo Clinic students and employees Exclusion Criteria: Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness) Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain Participants that have used drugs/alcohol the day prior to the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Google Cardboard Virtual Reality headset running an interactive game | Device: Virtual Reality<br>* Google Cardboard virtual reality headset<br>Other: Cold Pressor<br>* A cold ice water bath for use in pain/discomfort simulation<br>* Other names: Cold Pressor Test;|
| Sham Comparator: Control<br>Powered down Google Cardboard Virtual Reality headset | Other: Cold Pressor<br>* A cold ice water bath for use in pain/discomfort simulation<br>* Other names: Cold Pressor Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Tolerance | Likert Scale, 0-10 | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain threshold | Onset of pain/discomfort as expressed verbally, in seconds and minutes | 10 minutes | 
| maximal pain | Likert scale | 10 minutes | 
| Nausea | modified Likert scale | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain tolerance, perioperative pain, virtual reality therapy