Evaluating VR Therapy Using Cold Pressor Test

June 7, 2019 updated by: Janet Vittone

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janet Vittone

Investigators

  • Principal Investigator: Janet Vittone, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2017

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-004181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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