xml: <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/NCT05966402</url>
    </required_header>
    <id_info>
      <org_study_id>19-197</org_study_id>
      <nct_id>NCT05966402</nct_id>
    </id_info>
    <brief_title>Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.</brief_title>
    <acronym>IRVARI</acronym>
    <official_title>Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</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>
        Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea,&#xD;
        mountain, countryside…) to immerse them in an emotionally positive environment. The objective&#xD;
        is to reduce the anxiety and pain associated with IR acts in the operating room.&#xD;
  &#xD;
        Hypothesis tested:&#xD;
  &#xD;
        The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an&#xD;
        interventional radiology intervention would reduce the anxiety felt by patients by 25%,&#xD;
        evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD&#xD;
        scales will also be tested.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 17, 2021</start_date>
    <completion_date type="Actual">July 19, 2023</completion_date>
    <primary_completion_date type="Actual">July 19, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>anxiety measured with STAI Y-B</measure>
      <time_frame>once (as close as possible to the interventional gesture, i.e. just after it.)</time_frame>
      <description>For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">150</enrollment>
    <condition>Interventional Imaging</condition>
    <arm_group>
      <arm_group_label>Virtual Reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual Reality</intervention_name>
      <description>Immersion in Virtual Reality</description>
      <arm_group_label>Virtual Reality</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients (18-80 years old) with an indication for performing one of the following&#xD;
               interventional radiology procedures, according to HAS recommendations: Liver biopsy&#xD;
               puncture, embolization of varicoceles, embolization of pelvic varices, embolization of&#xD;
               uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma,&#xD;
               radioembolization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#xD;
  &#xD;
            -  Minor or age &gt; 80 years.&#xD;
  &#xD;
            -  People suffering from psychiatric pathologies, chronic depressive syndrome or chronic&#xD;
               anxiety disorder.&#xD;
  &#xD;
            -  People with a high risk of motion sickness during virtual reality immersion (MMSQ and&#xD;
               VIMSSQ &gt; 80th percentile).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CAEN University Hospital</name>
        <address>
          <city>Caen</city>
          <zip>14033</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966402
  org study id: 19-197
  nct id: NCT05966402
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea,
        mountain, countryside…) to immerse them in an emotionally positive environment. The objective
        is to reduce the anxiety and pain associated with IR acts in the operating room.
  
        Hypothesis tested:
  
        The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an
        interventional radiology intervention would reduce the anxiety felt by patients by 25%,
        evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD
        scales will also be tested.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: anxiety measured with STAI Y-B
  time frame: once (as close as possible to the interventional gesture, i.e. just after it.)
  description: For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.
  arm group label: Virtual Reality
  arm group type: Experimental
  arm group label: standard care
  arm group type: No Intervention
  intervention type: Other
  intervention name: Virtual Reality
  description: Immersion in Virtual Reality
  arm group label: Virtual Reality
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No