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OpenTrials
Completed

NCT Number: NCT03268863

Evaluating VR Therapy Using Cold Pressor Test

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

Google Cardboard virtual reality headset

Cold Pressor

Other

A cold ice water bath for use in pain/discomfort simulation

Other names: Cold Pressor Test

Primary outcomes

  1. Pain Tolerance

    Time frame: 10 minutes

    Likert Scale, 0-10

Secondary outcomes

  1. Pain threshold

    Time frame: 10 minutes

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

  2. maximal pain

    Time frame: 10 minutes

    Likert scale

  3. Nausea

    Time frame: 10 minutes

    modified Likert scale

Sponsors and collaborators

Lead sponsor

Janet Vittone

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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