CompletedNCT03268863Updated Jun 11, 2019

Evaluating VR Therapy Using Cold Pressor Test

An interventional study of Virtual Reality and Cold Pressor in Pain, sponsored by Janet Vittone. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by Janet Vittone · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Pain

Keywords

pain tolerance
perioperative pain
virtual reality therapy

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy adult Mayo Clinic students and employees

Exclusion criteria

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 design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Experimental
Virtual Reality
Google Cardboard Virtual Reality headset running an interactive game
Device: Virtual Reality · Other: Cold Pressor
Sham comparator
Control
Powered down Google Cardboard Virtual Reality headset
Other: Cold Pressor

Interventions

DeviceVirtual Reality
Google Cardboard virtual reality headset
OtherCold Pressor
A cold ice water bath for use in pain/discomfort simulation
Also known as: Cold Pressor Test

What researchers measure

Primary outcomes

Pain Tolerance
Likert Scale, 0-10
Time frame: 10 minutes

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03268863
Lead sponsor: Janet Vittone
Responsible party: Janet Vittone (Consultant, General Internal Medicine, Mayo Clinic) — Sponsor-investigator
First posted: Aug 31, 2017
Start date: Sep 10, 2017
Primary completion: Jul 10, 2018
Completion: Jul 20, 2018
Last update: Jun 11, 2019

Study contacts

Janet Vittone

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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