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/NCT05999578</url>
    </required_header>
    <id_info>
      <org_study_id>CHUBX 2022/79</org_study_id>
      <nct_id>NCT05999578</nct_id>
    </id_info>
    <brief_title>Contribution of Hypnosis on Image Quality in Cardiac MRI</brief_title>
    <acronym>HYPNOLINE</acronym>
    <official_title>Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Bordeaux</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Bordeaux</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>
        The present project aims to explore the effect of a hypnosis session performed on a patient&#xD;
        with anxiety during a cardiac MRI examination on image quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital&#xD;
        that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the&#xD;
        increase in activity of cardiology care channels and the extension of clinical indications&#xD;
        for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of&#xD;
        many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for&#xD;
        a cardiac MRI is 3 and a half months.&#xD;
  &#xD;
        In this context, it is necessary to be efficient because any procedure failure, examination&#xD;
        interruption or insufficient image quality can delay the diagnosis and therapeutic management&#xD;
        of the patient for several months. Numerous studies have shown that anxiety induces&#xD;
        interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging&#xD;
        the examination time.&#xD;
  &#xD;
        However, no study takes into account the specificity of cardiac MRI, whose image quality is&#xD;
        intimately linked to the patient's cooperation and to the synchronization of the sequences&#xD;
        with the heart rhythm.&#xD;
  &#xD;
        Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the&#xD;
        surrounding reality while remaining in relation with the attendant.&#xD;
  &#xD;
        The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac&#xD;
        MRI would be improved.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>quality of cardiac MRI images</measure>
      <time_frame>Baseline</time_frame>
      <description>Likert score measurements</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>number of artifacts</measure>
      <time_frame>Baseline</time_frame>
      <description>The number of artifacts will be estimated with European CMR Registry objective score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic validation score</measure>
      <time_frame>Baseline</time_frame>
      <description>The diagnostic validation score for the entire examination (and not sequence by sequence) makes it possible to define whether, despite the presence of artifacts, the examination makes it possible to answer the question initially asked in the examination request.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Causality score measurement</measure>
      <time_frame>Baseline</time_frame>
      <description>Causality score measurement for examinations with a Likert score &lt; 4</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall duration</measure>
      <time_frame>Baseline</time_frame>
      <description>The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of repeated or interrupted sequences</measure>
      <time_frame>Baseline</time_frame>
      <description>The number of repeated or interrupted sequences (by the Radiographer or the patient).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety level</measure>
      <time_frame>Baseline</time_frame>
      <description>The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-MRI satisfaction score</measure>
      <time_frame>Baseline</time_frame>
      <description>The post-MRI satisfaction score will be estimated from the patient by a visual analog scale rated from 0 (not at all satisfied) to 10 (very satisfied).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Anxious patients with hypnosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hypnosis support before, during and at the end of cardiac MRI exam</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anxious patients without hypnosis</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Cardiac MRI exam accordingly to usual care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non anxious patients</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Cardiac MRI exam accordingly to usual care</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hypnosis</intervention_name>
      <description>Hypnosis support before, during and at the end of cardiac MRI exam</description>
      <arm_group_label>Anxious patients with hypnosis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational)&#xD;
               ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE &lt; 46)&#xD;
               requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the&#xD;
               patients with cardiac arrhythmias or irregular heartbeats.&#xD;
  &#xD;
            -  18 years and older&#xD;
  &#xD;
            -  Highly effective contraception for women of childbearing potential, maintained during&#xD;
               research procedures&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
            -  Affiliated or beneficiary of health insurance&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications to MRI and gadoline contrast medium&#xD;
  &#xD;
            -  Hearing impaired patients&#xD;
  &#xD;
            -  Patients who do not speak French&#xD;
  &#xD;
            -  Women who are pregnant or lactating&#xD;
  &#xD;
            -  Inability to agree to participate to the study&#xD;
  &#xD;
            -  Patient under legal protection&#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>Amandine ANDRE-BILLEAU</last_name>
      <phone>+33557820000</phone>
      <phone_ext>74634</phone_ext>
      <email>amandine.andre@chu-bordeaux.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Bordeaux</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Amandine ANDRE-BILLEAU</last_name>
        <phone>+33557820000</phone>
        <phone_ext>74634</phone_ext>
        <email>amandine.andre@chu-bordeaux.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hypnosis</keyword>
    <keyword>cardiac MRI</keyword>
    <keyword>anxiety</keyword>
    <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/NCT05999578
  org study id: CHUBX 2022/79
  nct id: NCT05999578
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present project aims to explore the effect of a hypnosis session performed on a patient
        with anxiety during a cardiac MRI examination on image quality.
  Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital
        that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the
        increase in activity of cardiology care channels and the extension of clinical indications
        for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of
        many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for
        a cardiac MRI is 3 and a half months.
  
        In this context, it is necessary to be efficient because any procedure failure, examination
        interruption or insufficient image quality can delay the diagnosis and therapeutic management
        of the patient for several months. Numerous studies have shown that anxiety induces
        interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging
        the examination time.
  
        However, no study takes into account the specificity of cardiac MRI, whose image quality is
        intimately linked to the patient's cooperation and to the synchronization of the sequences
        with the heart rhythm.
  
        Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the
        surrounding reality while remaining in relation with the attendant.
  
        The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac
        MRI would be improved.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: quality of cardiac MRI images
  time frame: Baseline
  description: Likert score measurements
  measure: number of artifacts
  time frame: Baseline
  description: The number of artifacts will be estimated with European CMR Registry objective score.
  measure: Diagnostic validation score
  time frame: Baseline
  description: The diagnostic validation score for the entire examination (and not sequence by sequence) makes it possible to define whether, despite the presence of artifacts, the examination makes it possible to answer the question initially asked in the examination request.
  measure: Causality score measurement
  time frame: Baseline
  description: Causality score measurement for examinations with a Likert score < 4
  measure: Overall duration
  time frame: Baseline
  description: The overall duration of the examination and the different phases (reception and preparation time, image acquisition time).
  measure: Number of repeated or interrupted sequences
  time frame: Baseline
  description: The number of repeated or interrupted sequences (by the Radiographer or the patient).
  measure: Anxiety level
  time frame: Baseline
  description: The Spielberg State Anxiety Index STAI-Y anxiety score will be used to estimate patient anxiety before and after the MRI.
  measure: Post-MRI satisfaction score
  time frame: Baseline
  description: The post-MRI satisfaction score will be estimated from the patient by a visual analog scale rated from 0 (not at all satisfied) to 10 (very satisfied).
  arm group label: Anxious patients with hypnosis
  arm group type: Experimental
  description: Hypnosis support before, during and at the end of cardiac MRI exam
  arm group label: Anxious patients without hypnosis
  arm group type: No Intervention
  description: Cardiac MRI exam accordingly to usual care
  arm group label: Non anxious patients
  arm group type: No Intervention
  description: Cardiac MRI exam accordingly to usual care
  intervention type: Other
  intervention name: Hypnosis
  description: Hypnosis support before, during and at the end of cardiac MRI exam
  arm group label: Anxious patients with hypnosis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amandine ANDRE-BILLEAU
  phone: +33557820000
  phone ext: 74634
  email: amandine.andre@chu-bordeaux.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No