<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268863</url>
  </required_header>
  <id_info>
    <org_study_id>17-004181</org_study_id>
    <nct_id>NCT03268863</nct_id>
  </id_info>
  <brief_title>Evaluating VR Therapy Using Cold Pressor Test</brief_title>
  <official_title>Using the Cold Pressor Test to Assess Effectiveness of Low-Cost, Immersive Virtual Reality Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janet Vittone</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile&#xD;
      phones can be used as a potential distractor from pain and thus would have clinical&#xD;
      applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients&#xD;
      undergoing painful or uncomfortable procedures. To do this, the investigators are asking&#xD;
      volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either&#xD;
      while playing an interactive virtual reality game on the headset, or while wearing a VR&#xD;
      headset that is turned off as a control. The investigators will record the participants'&#xD;
      tolerance to cold water as measured by how long the participants are able to keep their hand&#xD;
      in the cold water.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Actual">July 20, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Tolerance</measure>
    <time_frame>10 minutes</time_frame>
    <description>Likert Scale, 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>10 minutes</time_frame>
    <description>Onset of pain/discomfort as expressed verbally, in seconds and minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maximal pain</measure>
    <time_frame>10 minutes</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>10 minutes</time_frame>
    <description>modified Likert scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Virtual Reality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Google Cardboard Virtual Reality headset running an interactive game</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Powered down Google Cardboard Virtual Reality headset</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <description>Google Cardboard virtual reality headset</description>
    <arm_group_label>Virtual Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold Pressor</intervention_name>
    <description>A cold ice water bath for use in pain/discomfort simulation</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Virtual Reality</arm_group_label>
    <other_name>Cold Pressor Test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult Mayo Clinic students and employees&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are known to be sensitive to VR technology and/or have undesirable&#xD;
             reactions to VR technology (i.e. dizziness, motion sickness)&#xD;
&#xD;
          -  Participants with significant alcohol/smoking histories, sickle cell anemia, history&#xD;
             of previous myocardial infarction and/or coronary artery disease, malignant&#xD;
             hypertension, metabolic&#xD;
&#xD;
          -  dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic&#xD;
             pain conditions, or diseases producing neuropathic pain&#xD;
&#xD;
          -  Participants that have used drugs/alcohol the day prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janet Vittone</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 7, 2019</last_update_submitted>
  <last_update_submitted_qc>June 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Janet Vittone</investigator_full_name>
    <investigator_title>Consultant, General Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>pain tolerance</keyword>
  <keyword>perioperative pain</keyword>
  <keyword>virtual reality therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasoconstrictor Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268863
org study id: 17-004181
nct id: NCT03268863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain Tolerance
time frame: 10 minutes
description: Likert Scale, 0-10
measure: Pain threshold
time frame: 10 minutes
description: Onset of pain/discomfort as expressed verbally, in seconds and minutes
measure: maximal pain
time frame: 10 minutes
description: Likert scale
measure: Nausea
time frame: 10 minutes
description: modified Likert scale
arm group label: Virtual Reality
arm group type: Experimental
description: Google Cardboard Virtual Reality headset running an interactive game
arm group label: Control
arm group type: Sham Comparator
description: Powered down Google Cardboard Virtual Reality headset
intervention type: Device
intervention name: Virtual Reality
description: Google Cardboard virtual reality headset
arm group label: Virtual Reality
intervention type: Other
intervention name: Cold Pressor
description: A cold ice water bath for use in pain/discomfort simulation
arm group label: Control
arm group label: Virtual Reality
other name: Cold Pressor Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janet Vittone
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Janet Vittone
investigator title: Consultant, General Internal Medicine
mesh term: Vasoconstrictor Agents
sharing ipd: No