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Evaluating VR Therapy Using Cold Pressor Test

Sponsor
Janet Vittone (Other)
Overall Status
Completed
CT.gov ID
NCT03268863
Collaborator
(none)
48
Enrollment
2
Locations
2
Arms
10.3
Actual Duration (Months)
24
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
  • Other: Cold Pressor
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy
Actual Study Start Date :
Sep 10, 2017
Actual Primary Completion Date :
Jul 10, 2018
Actual Study Completion Date :
Jul 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality

Google Cardboard Virtual Reality headset running an interactive game

Device: Virtual Reality
Google Cardboard virtual reality headset

Other: Cold Pressor
A cold ice water bath for use in pain/discomfort simulation
Other Names:
  • Cold Pressor Test

    		•
    Sham Comparator: Control

    Powered down Google Cardboard Virtual Reality headset

    Other: Cold Pressor
    A cold ice water bath for use in pain/discomfort simulation
    Other Names:
  • Cold Pressor Test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Tolerance [10 minutes]

      Likert Scale, 0-10

    Secondary Outcome Measures

    1. Pain threshold [10 minutes]

      Onset of pain/discomfort as expressed verbally, in seconds and minutes

    2. maximal pain [10 minutes]

      Likert scale

    3. Nausea [10 minutes]

      modified Likert scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    2 Mayo Clinic in Rochester Rochester Minnesota United States 55901

    Sponsors and Collaborators

    • Janet Vittone

    Investigators

    • Principal Investigator: Janet Vittone, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janet Vittone, Consultant, General Internal Medicine, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03268863
    Other Study ID Numbers:
    • 17-004181
    First Posted:
    Aug 31, 2017
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Janet Vittone, Consultant, General Internal Medicine, Mayo Clinic
    pain tolerance
    perioperative pain
    virtual reality therapy
    Additional relevant MeSH terms:
    Vasoconstrictor Agents

    Study Results

    No Results Posted as of Jun 11, 2019