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/NCT06017947</url>
    </required_header>
    <id_info>
      <org_study_id>2023/CHU/02</org_study_id>
      <nct_id>NCT06017947</nct_id>
    </id_info>
    <brief_title>Evaluation of a Musical Intervention on the Anxiety of Patients With a Diagnosis of Acute Coronary Syndrome in a Pre-Hospital Emergency Situation: MuSCA Randomized Controlled Trial</brief_title>
    <acronym>MuSCA</acronym>
    <official_title>Evaluation of a Musical Intervention on the Anxiety of Patients With a Diagnosis of Acute Coronary Syndrome in a Pre-Hospital Emergency Situation: MuSCA Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de la Réunion</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de la Réunion</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>
        Acute coronary syndrome (ACS) encompasses a continuum of clinical situations secondary to&#xD;
        acute myocardial ischemia. In France, it is a major health problem and represented 60,000 to&#xD;
        65,000 hospitalizations in 2010. In 2015, a diagnosis of ACS was made in 15 to 25% of&#xD;
        patients consulting for chest pain in emergency medicine.&#xD;
  &#xD;
        The incidence of ACS is estimated between 80,000 and 100,000 new cases per year. At the&#xD;
        University Hospital Center (CHU) of Réunion, acute chest pain is the leading cause of&#xD;
        discharges from the Mobile Emergency and Resuscitation Service (SMUR). In 2019, it&#xD;
        represented 23% of exits, 8.5% of which concerned SCAs.&#xD;
  &#xD;
        The SCA can be anxiety-provoking due to its unexpected and brutal nature. Pain related to&#xD;
        myocardial ischemia generates anxiety. This increases when patients associate these pains&#xD;
        with death. This anxiety is exacerbated by waiting times for care, especially for patients&#xD;
        living in rural areas. In addition, conditions relating to medical care such as noise and the&#xD;
        pre-hospital medical environment are perceived as influencing anxiety by patients.&#xD;
  &#xD;
        The prevalence of anxiety is high, ranging from 30 to 48.5%, in patients with chest pain&#xD;
        and/or ACS. A 2020 meta-analysis revealed that anxious patients at the start of their ACS&#xD;
        treatment had an increased risk of death, non-fatal myocardial infarction, rehospitalization,&#xD;
        recurrence of ACS and the need for coronary revascularization repeated. Overall, ACS patients&#xD;
        with anxiety have a 21% increased risk of mortality and 47% increased risk of adverse&#xD;
        cardiovascular events compared to those without anxiety.&#xD;
  &#xD;
        Pre-hospital anxiolytic treatment is therefore essential and consists above all in reassuring&#xD;
        the patient with ACS. Medicated anxiolytics are often combined with analgesics and&#xD;
        recommended in front of a picture of agitation due to anxiety. However, negative effects may&#xD;
        interfere, making clinical monitoring of these patients unsuitable. At the same time, several&#xD;
        studies note that anxiety is underdiagnosed and undertreated in the care of these patients.&#xD;
  &#xD;
        In reducing the anxiety of patients with ACS, unconventional care techniques such as&#xD;
        aromatherapy or touch massage have demonstrated their effectiveness. Music therapy is&#xD;
        recognized in reducing the anxiety of patients in intensive care or Cardiology.&#xD;
  &#xD;
        To the knowledge, in France, the effect of a musical intervention on patients with&#xD;
        pre-hospital ACS has not yet been studied. It is in this context that the MuSCA study takes&#xD;
        place.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 12, 2023</start_date>
    <completion_date type="Anticipated">June 11, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 11, 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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety change</measure>
      <time_frame>20 minutes</time_frame>
      <description>This is to assess whether a 20-minute musical intervention associated with the usual care would reduce the anxiety of the patient suffering from an acute coronary syndrome in pre-hospital during his transfer to a health establishment. (intervention group) compared to usual management alone (control group).&#xD;
  measurement méthod : analog visual scale</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain change</measure>
      <time_frame>20 minutes</time_frame>
      <description>assess whether a musical intervention associated with the usual care allows a reduction, during the transfer to a health establishment of the pain score (Numerical Scale)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Acute Coronary Syndrome</condition>
    <arm_group>
      <arm_group_label>standard process</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Musical intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Music care</intervention_name>
      <description>20 min music listening during transportation to hospital</description>
      <arm_group_label>Musical intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 and over&#xD;
  &#xD;
            -  With an established or suspected Acute Coronary Syndrome diagnosis&#xD;
  &#xD;
            -  With a stable clinical condition at the initial assessment:&#xD;
  &#xD;
            -  Whose anxiety assessment is &gt; or = 30/100 mm on the Visual Analogue Scale&#xD;
  &#xD;
            -  Having provided express, free and informed consent&#xD;
  &#xD;
            -  With an estimated transport time of at least &gt; 30 minutes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under guardianship, curatorship or judicial safeguard procedure&#xD;
  &#xD;
            -  With hearing and visual impairments&#xD;
  &#xD;
            -  Participating in another clinical trial or having already been included in this study.&#xD;
  &#xD;
            -  Supported by helicopter&#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>Alexis LEBON</last_name>
      <phone>+262262359000</phone>
      <email>promotion.drci@chu-reunion.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier Universitaire</name>
        <address>
          <city>Saint Pierre</city>
          <state>Île De La Réunion</state>
          <zip>97448</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexis LE BON</last_name>
      </contact>
      <investigator>
        <last_name>Alexis LEBON</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Acute Coronary Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <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/NCT06017947
  org study id: 2023/CHU/02
  nct id: NCT06017947
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute coronary syndrome (ACS) encompasses a continuum of clinical situations secondary to
        acute myocardial ischemia. In France, it is a major health problem and represented 60,000 to
        65,000 hospitalizations in 2010. In 2015, a diagnosis of ACS was made in 15 to 25% of
        patients consulting for chest pain in emergency medicine.
  
        The incidence of ACS is estimated between 80,000 and 100,000 new cases per year. At the
        University Hospital Center (CHU) of Réunion, acute chest pain is the leading cause of
        discharges from the Mobile Emergency and Resuscitation Service (SMUR). In 2019, it
        represented 23% of exits, 8.5% of which concerned SCAs.
  
        The SCA can be anxiety-provoking due to its unexpected and brutal nature. Pain related to
        myocardial ischemia generates anxiety. This increases when patients associate these pains
        with death. This anxiety is exacerbated by waiting times for care, especially for patients
        living in rural areas. In addition, conditions relating to medical care such as noise and the
        pre-hospital medical environment are perceived as influencing anxiety by patients.
  
        The prevalence of anxiety is high, ranging from 30 to 48.5%, in patients with chest pain
        and/or ACS. A 2020 meta-analysis revealed that anxious patients at the start of their ACS
        treatment had an increased risk of death, non-fatal myocardial infarction, rehospitalization,
        recurrence of ACS and the need for coronary revascularization repeated. Overall, ACS patients
        with anxiety have a 21% increased risk of mortality and 47% increased risk of adverse
        cardiovascular events compared to those without anxiety.
  
        Pre-hospital anxiolytic treatment is therefore essential and consists above all in reassuring
        the patient with ACS. Medicated anxiolytics are often combined with analgesics and
        recommended in front of a picture of agitation due to anxiety. However, negative effects may
        interfere, making clinical monitoring of these patients unsuitable. At the same time, several
        studies note that anxiety is underdiagnosed and undertreated in the care of these patients.
  
        In reducing the anxiety of patients with ACS, unconventional care techniques such as
        aromatherapy or touch massage have demonstrated their effectiveness. Music therapy is
        recognized in reducing the anxiety of patients in intensive care or Cardiology.
  
        To the knowledge, in France, the effect of a musical intervention on patients with
        pre-hospital ACS has not yet been studied. It is in this context that the MuSCA study takes
        place.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Anxiety change
  time frame: 20 minutes
  description: This is to assess whether a 20-minute musical intervention associated with the usual care would reduce the anxiety of the patient suffering from an acute coronary syndrome in pre-hospital during his transfer to a health establishment. (intervention group) compared to usual management alone (control group).
  measurement méthod : analog visual scale
  measure: Pain change
  time frame: 20 minutes
  description: assess whether a musical intervention associated with the usual care allows a reduction, during the transfer to a health establishment of the pain score (Numerical Scale)
  arm group label: standard process
  arm group type: No Intervention
  arm group label: Musical intervention
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Music care
  description: 20 min music listening during transportation to hospital
  arm group label: Musical intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexis LEBON
  phone: +262262359000
  email: promotion.drci@chu-reunion.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Acute Coronary Syndrome
  mesh term: Syndrome
  mesh term: Emergencies
  sharing ipd: No