<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/NCT04481893</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00182-37</org_study_id>
    <nct_id>NCT04481893</nct_id>
  </id_info>
  <brief_title>Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy</brief_title>
  <acronym>ThyroVir</acronym>
  <official_title>Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse</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>
      Study the interest of hypnosis techniques by virtual reality based on the use of a virtual&#xD;
      reality headset with the AQUA® application on the reduction of pre-operative stress in&#xD;
      patients candidates for total thyroidectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 18, 2020</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Anxiety state (STAI-Y scale)</measure>
    <time_frame>Before surgery and up to 2 hours after surgery</time_frame>
    <description>The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Anxiety state(AE scale)</measure>
    <time_frame>Before surgery and up to 2 hours after surgery</time_frame>
    <description>The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>Anxiety score [minimum value 0 , up to maximum value (worse) 20] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evaluation (Visual Analog Pain Scale)</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)</measure>
    <time_frame>Up to 2 hours after surgery</time_frame>
    <description>score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taking of anxiolytics</measure>
    <time_frame>up to 1 month after surgery</time_frame>
    <description>variation of amount of anti-anxiety medication</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Thyroid Cancer</condition>
  <condition>Thyroidectomy</condition>
  <arm_group>
    <arm_group_label>using a virtual reality headset</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of a virtual reality headset</intervention_name>
    <description>The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application.&#xD;
The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room.&#xD;
The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)</description>
    <arm_group_label>using a virtual reality headset</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient&gt; 18 years old&#xD;
&#xD;
          -  Man or woman&#xD;
&#xD;
          -  Patient candidate for a total thyroidectomy, or a thyroid totalization&#xD;
&#xD;
          -  Preoperative Euthyroidism&#xD;
&#xD;
          -  Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1,&#xD;
             2 or 3 stable; accompanied for return at home; can be watched by a loved one the night&#xD;
             after returning home; reachable by telephone; living within an hour of transportation&#xD;
             from a hospital and having a good level of understanding.&#xD;
&#xD;
          -  No history of parathyroid or recurrent pathology&#xD;
&#xD;
          -  Signature of informed consent before any specific procedure related to the study&#xD;
&#xD;
          -  Subject affiliated with a health security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a submerged goiter (lower edge of the thyroid not seen on the&#xD;
             preoperative cervical ultrasound)&#xD;
&#xD;
          -  Patient with uncontrolled infectious pathology&#xD;
&#xD;
          -  Pregnant or breastfeeding woman or lack of contraception during genital activity&#xD;
&#xD;
          -  Patient with illnesses or conditions that hinder their ability to understand follow&#xD;
             and / or comply with study procedures&#xD;
&#xD;
          -  Patient with personality disorders and / or psychiatric pathology&#xD;
&#xD;
          -  Patient deprived of liberty or placed under the authority of a guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Vianney BASTIT, MD</last_name>
    <phone>0231455050</phone>
    <email>v.bastit@baclesse.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vianney BASTIT, MD</last_name>
      <email>v.bastit@baclesse.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU CAEN</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emmanuela BABIN, Prof</last_name>
      <email>babin-e@chu-caen.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Mathilde</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas BON-MARDION, MD</last_name>
      <email>nicolas.bon-mardion@clinique-mathilde.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual reality headset</keyword>
  <keyword>stress</keyword>
  <keyword>hypnose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
  </condition_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/NCT04481893
org study id: 2020-A00182-37
nct id: NCT04481893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study the interest of hypnosis techniques by virtual reality based on the use of a virtual
      reality headset with the AQUA® application on the reduction of pre-operative stress in
      patients candidates for total thyroidectomy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change of Anxiety state (STAI-Y scale)
time frame: Before surgery and up to 2 hours after surgery
description: The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
measure: Change of Anxiety state(AE scale)
time frame: Before surgery and up to 2 hours after surgery
description: The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
measure: Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
time frame: up to 1 month after surgery
description: Anxiety score [minimum value 0 , up to maximum value (worse) 20] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS)
measure: Pain evaluation (Visual Analog Pain Scale)
time frame: up to 1 month after surgery
description: Score on the VAS pain scale [minimum value 0, up to maximum value (worse) 10]
measure: Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)
time frame: Up to 2 hours after surgery
description: score of EVAN-G questionnaire [minimum value 0, up to maximum value (worse) 100]
measure: Taking of anxiolytics
time frame: up to 1 month after surgery
description: variation of amount of anti-anxiety medication
arm group label: using a virtual reality headset
arm group type: Experimental
intervention type: Behavioral
intervention name: Use of a virtual reality headset
description: The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application.
The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room.
The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)
arm group label: using a virtual reality headset
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vianney BASTIT, MD
phone: 0231455050
email: v.bastit@baclesse.unicancer.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
sharing ipd: No