<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/NCT03817775</url>
  </required_header>
  <id_info>
    <org_study_id>MusicSeda</org_study_id>
    <nct_id>NCT03817775</nct_id>
  </id_info>
  <brief_title>Effect of Music on the Sedative Use During Coronary Angioplasty</brief_title>
  <official_title>Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association de Musicothérapie Applications et Recherches Cliniques</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Hospital of Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association de Musicothérapie Applications et Recherches Cliniques</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>
      This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will&#xD;
      be recruited from the coronary angiography patient pool of the American Hospital of Paris and&#xD;
      assigned to one of 2 groups in a non-randomized manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-blinded, non-randomized controlled pilot study with patients who will be&#xD;
      followed during their coronary angiography procedure and with no follow-up. Patients will be&#xD;
      recruited from the coronary angiography patient pool of the American Hospital of Paris and&#xD;
      assigned to one of 2 groups in a non-randomized manner. It is expected to enroll around 100&#xD;
      patients and this is estimated to be obtained in a period of 2 months approximately. Patients&#xD;
      will be placed in the control group, without music intervention, or assigned to the music&#xD;
      group. Assignment will be done in this manner due to limited availability of the hardware and&#xD;
      software to the investigation team. Patients in both groups will be matched based on age,&#xD;
      sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical&#xD;
      history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient&#xD;
      will receive a standardized sedation in the traditional manner and at the discretion of the&#xD;
      investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The&#xD;
      primary study end points will be the consumptions in analgesics and hypnotics. Secondary&#xD;
      study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS),&#xD;
      the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale&#xD;
      (APAIS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">April 3, 2019</completion_date>
  <primary_completion_date type="Actual">April 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner: Control or music intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Use of Midazolam Medication (mg)</measure>
    <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
    <description>The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Use of Propofol Medication (mg)</measure>
    <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
    <description>The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose Use of Sufentanil Medication (ug)</measure>
    <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
    <description>The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>From 0 up to 45 minutes.</time_frame>
    <description>Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Score (NRS)</measure>
    <time_frame>From 0 up to 45 minutes.</time_frame>
    <description>Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of the Patient</measure>
    <time_frame>Right after the end of the procedure in the recovery room.</time_frame>
    <description>Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on Physiological Parameters: BIS</measure>
    <time_frame>10 minutes prior to the beginning of the procedure</time_frame>
    <description>Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.&#xD;
The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on Physiological Parameters: Heart Rate</measure>
    <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
    <description>Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on Physiological Parameters: SpO2%</measure>
    <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
    <description>SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on Physiological Parameters: Mean Arterial Blood Pressure</measure>
    <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
    <description>Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Coronary Angioplasty</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will undergo coronary angiography without music intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Music therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music therapy</intervention_name>
    <description>The intervention group will administer &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
    <arm_group_label>Music therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient needs a coronary angiography&#xD;
&#xD;
          -  Patient gives verbal consent to participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient aged less than 18 years at time of enrollment&#xD;
&#xD;
          -  Patient doesn't like music for cultural reason&#xD;
&#xD;
          -  Patient with serious psychiatric disorders&#xD;
&#xD;
          -  Patient with not paired deafness or paired one with devices that are incompatible with&#xD;
             wearing a headset.&#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_official>
    <last_name>Gilles BOCCARA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesia and Intensive Care, American Hospital of Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Hospital of Paris</name>
      <address>
        <city>Neuilly-sur-Seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.</citation>
    <PMID>17085009</PMID>
  </reference>
  <reference>
    <citation>Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.</citation>
    <PMID>22001666</PMID>
  </reference>
  <reference>
    <citation>Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.</citation>
    <PMID>27618935</PMID>
  </reference>
  <reference>
    <citation>Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.</citation>
    <PMID>27548494</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>June 27, 2019</results_first_submitted>
  <results_first_submitted_qc>October 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 2, 2019</results_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Music therapy</keyword>
  <keyword>sedation</keyword>
  <keyword>coronary angioplasty</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03817775/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03817775/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>The control group underwent coronary angiography without music intervention.</description>
        </group>
        <group group_id="P2">
          <title>Music Therapy</title>
          <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>The control group underwent coronary angiography without music intervention.</description>
        </group>
        <group group_id="B2">
          <title>Music Therapy</title>
          <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="76"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.4" spread="13.37"/>
                    <measurement group_id="B2" value="67.2" spread="9.07"/>
                    <measurement group_id="B3" value="65.7" spread="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA Score</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal: Score 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate abnormality: Score 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe abnormality: Score 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Dose Use of Midazolam Medication (mg)</title>
        <description>The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.</description>
        <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Use of Midazolam Medication (mg)</title>
          <description>The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.84"/>
                    <measurement group_id="O2" value="1.2" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dose Use of Propofol Medication (mg)</title>
        <description>The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.</description>
        <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
        <population>One patient in control group and 2 patients in music therapy group had missing data on Propofol medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Use of Propofol Medication (mg)</title>
          <description>The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.</description>
          <population>One patient in control group and 2 patients in music therapy group had missing data on Propofol medication.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="21.83"/>
                    <measurement group_id="O2" value="52" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dose Use of Sufentanil Medication (ug)</title>
        <description>The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.</description>
        <time_frame>Between 10 minutes prior to the beginning of the procedure up to 45 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Use of Sufentanil Medication (ug)</title>
          <description>The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.</description>
          <units>ug</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="1.21"/>
                    <measurement group_id="O2" value="5.1" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7215</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score</title>
        <description>Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
        <time_frame>From 0 up to 45 minutes.</time_frame>
        <population>Three patients in control group and 3 patients in music therapy group had missing data on VAS pain score.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score</title>
          <description>Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
          <population>Three patients in control group and 3 patients in music therapy group had missing data on VAS pain score.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.70"/>
                    <measurement group_id="O2" value="0.7" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5675</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety Score (NRS)</title>
        <description>Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
        <time_frame>From 0 up to 45 minutes.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Score (NRS)</title>
          <description>Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.89"/>
                    <measurement group_id="O2" value="2.9" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction of the Patient</title>
        <description>Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.</description>
        <time_frame>Right after the end of the procedure in the recovery room.</time_frame>
        <population>Two patients in control group and 3 patients in music therapy group had missing data on satisfaction endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction of the Patient</title>
          <description>Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.</description>
          <population>Two patients in control group and 3 patients in music therapy group had missing data on satisfaction endpoint.</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.51"/>
                    <measurement group_id="O2" value="4.8" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect on Physiological Parameters: BIS</title>
        <description>Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.&#xD;
The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is.</description>
        <time_frame>10 minutes prior to the beginning of the procedure</time_frame>
        <population>2 missing data in control group</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Effect on Physiological Parameters: BIS</title>
          <description>Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.&#xD;
The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is.</description>
          <population>2 missing data in control group</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9" spread="2.1"/>
                    <measurement group_id="O2" value="94.9" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect on Physiological Parameters: Heart Rate</title>
        <description>Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
        <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Effect on Physiological Parameters: Heart Rate</title>
          <description>Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
          <units>beat/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.3" spread="13.1"/>
                    <measurement group_id="O2" value="65.5" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect on Physiological Parameters: SpO2%</title>
        <description>SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..</description>
        <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Effect on Physiological Parameters: SpO2%</title>
          <description>SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..</description>
          <units>Percentage of O2 saturation in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5" spread="1.4"/>
                    <measurement group_id="O2" value="98.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect on Physiological Parameters: Mean Arterial Blood Pressure</title>
        <description>Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
        <time_frame>10 minutes prior to the beginning of the procedure.</time_frame>
        <population>Two patients in control group and 1 in music therapy had missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>The control group underwent coronary angiography without music intervention.</description>
          </group>
          <group group_id="O2">
            <title>Music Therapy</title>
            <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
          </group>
        </group_list>
        <measure>
          <title>Effect on Physiological Parameters: Mean Arterial Blood Pressure</title>
          <description>Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.</description>
          <population>Two patients in control group and 1 in music therapy had missing data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.7" spread="14.1"/>
                    <measurement group_id="O2" value="104.2" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From 0 up to 45 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>The control group underwent coronary angiography without music intervention.</description>
        </group>
        <group group_id="E2">
          <title>Music Therapy</title>
          <description>The intervention group also underwent coronary angiography and administered music therapy between 10 minutes prior to the beginning of the procedure until its end.&#xD;
Music therapy: The intervention group administered &quot;U&quot; sequence between 10 minutes prior to the beginning of the procedure until its end.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Gilles BOCCARA</name_or_title>
      <organization>• Department of Anaesthesia and Intensive Care, American Hospital of Paris</organization>
      <phone>+33 1 46 41 25 25</phone>
      <email>gilles.boccara@ahparis.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03817775
org study id: MusicSeda
nct id: NCT03817775
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will
      be recruited from the coronary angiography patient pool of the American Hospital of Paris and
      assigned to one of 2 groups in a non-randomized manner.
This is a non-blinded, non-randomized controlled pilot study with patients who will be
      followed during their coronary angiography procedure and with no follow-up. Patients will be
      recruited from the coronary angiography patient pool of the American Hospital of Paris and
      assigned to one of 2 groups in a non-randomized manner. It is expected to enroll around 100
      patients and this is estimated to be obtained in a period of 2 months approximately. Patients
      will be placed in the control group, without music intervention, or assigned to the music
      group. Assignment will be done in this manner due to limited availability of the hardware and
      software to the investigation team. Patients in both groups will be matched based on age,
      sex, weight, height, American Society of Anesthesiology (ASA) score, and prior medical
      history, including diabetes, hypertension, chronic kidney disease and stroke. Each patient
      will receive a standardized sedation in the traditional manner and at the discretion of the
      investigator to reach Bispectral index (BIS) score below 90 and sedation score ≤ 1. The
      primary study end points will be the consumptions in analgesics and hypnotics. Secondary
      study end points will be pain and anxiety scores as measured the Numeric Rating Scale (NRS),
      the Visual Analog Scale (VAS) and the Amsterdam Preoperative Anxiety and Information Scale
      (APAIS).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner: Control or music intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Use of Midazolam Medication (mg)
time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
description: The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.
measure: Dose Use of Propofol Medication (mg)
time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
description: The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.
measure: Dose Use of Sufentanil Medication (ug)
time frame: Between 10 minutes prior to the beginning of the procedure up to 45 minutes.
description: The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.
measure: Pain Score
time frame: From 0 up to 45 minutes.
description: Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.
measure: Anxiety Score (NRS)
time frame: From 0 up to 45 minutes.
description: Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.
measure: Satisfaction of the Patient
time frame: Right after the end of the procedure in the recovery room.
description: Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.
measure: Effect on Physiological Parameters: BIS
time frame: 10 minutes prior to the beginning of the procedure
description: Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.
The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is.
measure: Effect on Physiological Parameters: Heart Rate
time frame: 10 minutes prior to the beginning of the procedure.
description: Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.
measure: Effect on Physiological Parameters: SpO2%
time frame: 10 minutes prior to the beginning of the procedure.
description: SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..
measure: Effect on Physiological Parameters: Mean Arterial Blood Pressure
time frame: 10 minutes prior to the beginning of the procedure.
description: Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.
arm group label: Control
arm group type: No Intervention
description: The control group will undergo coronary angiography without music intervention.
arm group label: Music therapy
arm group type: Experimental
description: The intervention group will also undergo coronary angiography and will administer music therapy between 10 minutes prior to the beginning of the procedure until its end.
intervention type: Other
intervention name: Music therapy
description: The intervention group will administer "U" sequence between 10 minutes prior to the beginning of the procedure until its end.
arm group label: Music therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles BOCCARA, PhD
role: Principal Investigator
affiliation: Department of Anaesthesia and Intensive Care, American Hospital of Paris
facility: 
country: France
citation: Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
PMID: 17085009
citation: Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
PMID: 22001666
citation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.
PMID: 27618935
citation: Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.
PMID: 27548494
responsible party type: Sponsor
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