<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/NCT04473495</url>
  </required_header>
  <id_info>
    <org_study_id>2019PI013</org_study_id>
    <nct_id>NCT04473495</nct_id>
  </id_info>
  <brief_title>The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.</brief_title>
  <acronym>VATIC</acronym>
  <official_title>The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <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 evaluates the impact of educative videos on anxiety for patients entering hospital&#xD;
      for cardiology intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>anxiety</measure>
    <time_frame>1 year</time_frame>
    <description>anxiety measured with STAI Y-A questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>video</arm_group_label>
    <description>patients who enjoyed an educational video</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>patients who didn't enjoy any educational video</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>educational video</intervention_name>
    <description>educational video before intervention</description>
    <arm_group_label>video</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient entering hospitalisation in cardiology department for a cardiology intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient entering hospitalisation in cardiology department for a cardiology&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  protected person.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Marc Sellal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Hospital, Nancy, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ugo Righetto</last_name>
    <phone>0033383153256</phone>
    <email>ugo.righetto@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean-Marc Sellal</last_name>
    <phone>0033383153256</phone>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <!-- 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/NCT04473495
org study id: 2019PI013
nct id: NCT04473495
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of educative videos on anxiety for patients entering hospital
      for cardiology intervention
observational model: Other
time perspective: Prospective
measure: anxiety
time frame: 1 year
description: anxiety measured with STAI Y-A questionnaire
arm group label: video
description: patients who enjoyed an educational video
arm group label: control
description: patients who didn't enjoy any educational video
intervention type: Device
intervention name: educational video
description: educational video before intervention
arm group label: video
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Marc Sellal
role: Principal Investigator
affiliation: Central Hospital, Nancy, France
last name: Ugo Righetto
phone: 0033383153256
email: ugo.righetto@gmail.com
last name: Jean-Marc Sellal
phone: 0033383153256
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Coronary Artery Disease
mesh term: Atrial Flutter