Evaluating VR Therapy Using Cold Pressor Test

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268863
• Other study ID #: 17-004181
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: June 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 20, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Virtual Reality
Google Cardboard virtual reality headset

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janet Vittone

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Tolerance	Likert Scale, 0-10	10 minutes
Secondary	Pain threshold	Onset of pain/discomfort as expressed verbally, in seconds and minutes	10 minutes
Secondary	maximal pain	Likert scale	10 minutes
Secondary	Nausea	modified Likert scale	10 minutes

External Links

•   Mayo Clinic Clinical Trials