<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/NCT03763058</url>
  </required_header>
  <id_info>
    <org_study_id>MusicMig</org_study_id>
    <nct_id>NCT03763058</nct_id>
  </id_info>
  <brief_title>Music Intervention on Migraine Headaches</brief_title>
  <acronym>CHU</acronym>
  <official_title>The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association de Musicothérapie Applications et Recherches Cliniques</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de la Réunion</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>
      Migraine is a frequent pathology, highly linked to anxio-depressive factors. Non-drug&#xD;
      approaches are part of the therapeutic arsenal. Music therapy is a recent discipline&#xD;
      expanding in hospital services and specialised ambulatory centers. The main objective of this&#xD;
      study is to assess the effect of &quot; U &quot; technique in receptive music therapy on migraine&#xD;
      frequency, on patients suffering from episodic migraines, through &quot; Music care &quot; software&#xD;
      home use. Secondary objectives are to assess this technique impact on migraine intensity,&#xD;
      duration, emotional effect (HAD score), functional impact (HIT-6 score), and acute treatment&#xD;
      administration. This is a monocentric prospective before-after study carried out in chronic&#xD;
      pain department of the CHU Sud Reunion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite converging evidence that music interventions are beneficial in a number of pain&#xD;
      domains, additional research is needed to understand the impact of a music intervention on&#xD;
      the debilitating nature of migraine headaches. Interestingly, a recently developed smartphone&#xD;
      application called Music Care has been introduced as a music-intervention tool; however music&#xD;
      type is controlled by the individual. A patient-controlled music intervention administered by&#xD;
      Music Care has shown to alleviate negative psychological (e.g., depression) and physiological&#xD;
      (e.g., pain and discomfort) outcomes associated with general chronic pain. However, no study&#xD;
      has examined how music interventions administered via Music Care may be beneficial for&#xD;
      individuals who experience migraines, thus potentially highlighting the effects of receptive&#xD;
      music techniques in music therapy.&#xD;
&#xD;
      Therefore, the present investigation sought to examine the potential benefits of a&#xD;
      patient-controlled, 3-month music intervention in individuals diagnosed with migraine&#xD;
      headaches using the Music Care application. Patients from the university hospital center Sud&#xD;
      Reunion (Saint Pierre, Reunion Island, France) within the Chronic Pain Consultation Group&#xD;
      will be evaluated for inclusion in the study and will complete the 3-month music&#xD;
      intervention. Participants will complete 1-2 sessions of listening to music per day, with a&#xD;
      minimum of 15 sessions per month.&#xD;
&#xD;
      The following measures will be collected: the frequency of migraine attacks, the average&#xD;
      duration of migraine attacks and the average intensity of migraine attacks. Patients will&#xD;
      also rate levels of anxiety and depression associated with migraine headaches via the&#xD;
      Hospital Anxiety and Depression Scale (HAD). The impact migraines have on everyday level of&#xD;
      functioning will be evaluated using the Headache Impact Test (HIT-6).&#xD;
&#xD;
      This is a pilot study, non-randomized, single arm and single center study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">March 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A monocentric prospective before-after study on patients carried out in chronic pain department of the CHU Sud Reunion. Patients will be evaluated for inclusion in the study, and will complete the 3-month music intervention. Participants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month. Before starting the musicotherapy program, retrospective data will be collected on the month prior regarding migraine attacks (frequency, severity, duration, treatment intake).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Migraine Attacks (Number of Days Per Month)</measure>
    <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
    <description>All data related to migraine like frequency, duration, severity are to be collected in a diary questionnaire. Per ANAES (Agence nationale de l'accréditation et de l'évaluation en santé) recommendations, this means reduction of 50% on frequency of migraine attacks after 3-month treatment period. Comparison will be done between the number of days in the month prior the first music intervention and the number of days in the 3rd month of intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Migraine Attacks (Hours)</measure>
    <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
    <description>The outcome is the mean duration of migraine attacks per month. Comparison will be done between the month prior the first music intervention and the 3rd month of intervention. The mean duration is calculated by summing the total duration during the month divided by the number of attacks in the month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Migraine Episodes With Severe Intensity</measure>
    <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
    <description>This data is collected as mild, moderate or severe. The same analysis as the primary outcome will be done by severity. So the frequency of migraine attacks will be compared for each severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Migraines on Everyday Level of Functioning</measure>
    <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
    <description>This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. A higher score indicates a worse impact of migraines on daily life. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction on Anxiety and Depression</measure>
    <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
    <description>This outcome will be evaluated using Hospital Anxiety and Depression Scale (HAD). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Migraine Headache</condition>
  <arm_group>
    <arm_group_label>Music intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
    <arm_group_label>Music intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with episodic migraine with at least 4 attacks per month&#xD;
&#xD;
          -  Patients with migraines with or without aura with diagnostic criteria per&#xD;
             International Headache Society&#xD;
&#xD;
          -  Patients with a migraine for more than one year&#xD;
&#xD;
          -  Diagnosis age &lt; 50 years&#xD;
&#xD;
          -  Patients with an available internet connexion to access Music Care application&#xD;
&#xD;
          -  Patients with minimal knowledge in informatics&#xD;
&#xD;
          -  Patients who sign their inform consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged less than 18 years&#xD;
&#xD;
          -  Patients with chronic migraine&#xD;
&#xD;
          -  Patients with epilepsy&#xD;
&#xD;
          -  Patients with a deficiency on auditive function&#xD;
&#xD;
          -  Patients with a disease that could be fatal within the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guilhem PARLONGUE, PhD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>CHU de la Réunion</name>
      <address>
        <city>Saint-Pierre</city>
        <zip>97448</zip>
        <country>Réunion</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Réunion</country>
  </location_countries>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Guetin S, Portet F, Picot MC, Defez C, Pose C, Blayac JP, Touchon J. [Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Encephale. 2009 Feb;35(1):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French.</citation>
    <PMID>19250995</PMID>
  </results_reference>
  <results_reference>
    <citation>Meister M, Einsle R, Brunner J, Rhyner K. [Psychofonia--a neurophysiologic music therapy in migraine]. Praxis (Bern 1994). 1999 May 20;88(21):946-9. German.</citation>
    <PMID>10412281</PMID>
  </results_reference>
  <results_reference>
    <citation>Koenig J, Oelkers-Ax R, Kaess M, Parzer P, Lenzen C, Hillecke TK, Resch F. Specific music therapy techniques in the treatment of primary headache disorders in adolescents: a randomized attention-placebo-controlled trial. J Pain. 2013 Oct;14(10):1196-207. doi: 10.1016/j.jpain.2013.05.006. Epub 2013 Jul 19.</citation>
    <PMID>23876282</PMID>
  </results_reference>
  <results_reference>
    <citation>Oelkers-Ax R, Leins A, Parzer P, Hillecke T, Bolay HV, Fischer J, Bender S, Hermanns U, Resch F. Butterbur root extract and music therapy in the prevention of childhood migraine: an explorative study. Eur J Pain. 2008 Apr;12(3):301-13. doi: 10.1016/j.ejpain.2007.06.003. Epub 2007 Jul 30.</citation>
    <PMID>17659990</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>May 1, 2019</results_first_submitted>
  <results_first_submitted_qc>May 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2019</results_first_posted>
  <last_update_submitted>July 21, 2019</last_update_submitted>
  <last_update_submitted_qc>July 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <keyword>Headache</keyword>
  <keyword>Music intervention</keyword>
  <keyword>Pain</keyword>
  <keyword>Smartphone application</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is not planned to share individual subjects data to other people.</ipd_description>
  </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>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03763058/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>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03763058/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.</recruitment_details>
      <pre_assignment_details>Thirty-two patients were screened but not enrolled and assigned to music intervention as they did not fill the inclusion/exclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Music Intervention</title>
          <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Music Intervention</title>
          <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" lower_limit="19" upper_limit="63"/>
                  </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="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Réunion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Migraine Attacks (Number of Days Per Month)</title>
        <description>All data related to migraine like frequency, duration, severity are to be collected in a diary questionnaire. Per ANAES (Agence nationale de l'accréditation et de l'évaluation en santé) recommendations, this means reduction of 50% on frequency of migraine attacks after 3-month treatment period. Comparison will be done between the number of days in the month prior the first music intervention and the number of days in the 3rd month of intervention.</description>
        <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music Intervention</title>
            <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Migraine Attacks (Number of Days Per Month)</title>
          <description>All data related to migraine like frequency, duration, severity are to be collected in a diary questionnaire. Per ANAES (Agence nationale de l'accréditation et de l'évaluation en santé) recommendations, this means reduction of 50% on frequency of migraine attacks after 3-month treatment period. Comparison will be done between the number of days in the month prior the first music intervention and the number of days in the 3rd month of intervention.</description>
          <units>Number of migraine per months</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.45" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.65" spread="3.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Sign test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.8</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>4.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Migraine Attacks (Hours)</title>
        <description>The outcome is the mean duration of migraine attacks per month. Comparison will be done between the month prior the first music intervention and the 3rd month of intervention. The mean duration is calculated by summing the total duration during the month divided by the number of attacks in the month.</description>
        <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music Intervention</title>
            <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Migraine Attacks (Hours)</title>
          <description>The outcome is the mean duration of migraine attacks per month. Comparison will be done between the month prior the first music intervention and the 3rd month of intervention. The mean duration is calculated by summing the total duration during the month divided by the number of attacks in the month.</description>
          <units>Hours</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.95" spread="16.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Sign test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.45</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>15.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Migraine Episodes With Severe Intensity</title>
        <description>This data is collected as mild, moderate or severe. The same analysis as the primary outcome will be done by severity. So the frequency of migraine attacks will be compared for each severity.</description>
        <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
        <population>Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Music Intervention</title>
            <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Migraine Episodes With Severe Intensity</title>
          <description>This data is collected as mild, moderate or severe. The same analysis as the primary outcome will be done by severity. So the frequency of migraine attacks will be compared for each severity.</description>
          <population>Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.</population>
          <units>Number of episodes</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="3.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.045</p_value>
            <method>Sign test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Impact of Migraines on Everyday Level of Functioning</title>
        <description>This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. A higher score indicates a worse impact of migraines on daily life. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</description>
        <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
        <population>Difference between post and pre-treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Music Intervention</title>
            <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Migraines on Everyday Level of Functioning</title>
          <description>This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. A higher score indicates a worse impact of migraines on daily life. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</description>
          <population>Difference between post and pre-treatment</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.75" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posttreatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.1" spread="6.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Sign test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.65</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>4.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reduction on Anxiety and Depression</title>
        <description>This outcome will be evaluated using Hospital Anxiety and Depression Scale (HAD). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</description>
        <time_frame>1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Music Intervention</title>
            <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction on Anxiety and Depression</title>
          <description>This outcome will be evaluated using Hospital Anxiety and Depression Scale (HAD). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anxiety HAD pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.05" spread="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety HAD post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression HAD pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression HAD post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="3.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Total HAD score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Sign test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.15</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>5.1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Music Intervention</title>
          <description>The music intervention is administered via a smartphone- (and computer-) based application called Music Care.&#xD;
Music Therapy: The music intervention was administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the &quot;U&quot; technique designed to gradually relax the listener. The &quot;U&quot; technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.&#xD;
Participants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.</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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="20"/>
              </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>
    <limitations_and_caveats>No control group&#xD;
Future studies to explore music intervention compared to other therapeutic options&#xD;
results to be interpreted with caution as headache symptoms are self-collected</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Guilhem Parlongue</name_or_title>
      <organization>Centre d'Evaluation et Traitement de la Douleur</organization>
      <phone>00262262912037</phone>
      <email>guilhem_parlongue@hotmail.com</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/NCT03763058
org study id: MusicMig
nct id: NCT03763058
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Migraine is a frequent pathology, highly linked to anxio-depressive factors. Non-drug
      approaches are part of the therapeutic arsenal. Music therapy is a recent discipline
      expanding in hospital services and specialised ambulatory centers. The main objective of this
      study is to assess the effect of " U " technique in receptive music therapy on migraine
      frequency, on patients suffering from episodic migraines, through " Music care " software
      home use. Secondary objectives are to assess this technique impact on migraine intensity,
      duration, emotional effect (HAD score), functional impact (HIT-6 score), and acute treatment
      administration. This is a monocentric prospective before-after study carried out in chronic
      pain department of the CHU Sud Reunion.
Despite converging evidence that music interventions are beneficial in a number of pain
      domains, additional research is needed to understand the impact of a music intervention on
      the debilitating nature of migraine headaches. Interestingly, a recently developed smartphone
      application called Music Care has been introduced as a music-intervention tool; however music
      type is controlled by the individual. A patient-controlled music intervention administered by
      Music Care has shown to alleviate negative psychological (e.g., depression) and physiological
      (e.g., pain and discomfort) outcomes associated with general chronic pain. However, no study
      has examined how music interventions administered via Music Care may be beneficial for
      individuals who experience migraines, thus potentially highlighting the effects of receptive
      music techniques in music therapy.

      Therefore, the present investigation sought to examine the potential benefits of a
      patient-controlled, 3-month music intervention in individuals diagnosed with migraine
      headaches using the Music Care application. Patients from the university hospital center Sud
      Reunion (Saint Pierre, Reunion Island, France) within the Chronic Pain Consultation Group
      will be evaluated for inclusion in the study and will complete the 3-month music
      intervention. Participants will complete 1-2 sessions of listening to music per day, with a
      minimum of 15 sessions per month.

      The following measures will be collected: the frequency of migraine attacks, the average
      duration of migraine attacks and the average intensity of migraine attacks. Patients will
      also rate levels of anxiety and depression associated with migraine headaches via the
      Hospital Anxiety and Depression Scale (HAD). The impact migraines have on everyday level of
      functioning will be evaluated using the Headache Impact Test (HIT-6).

      This is a pilot study, non-randomized, single arm and single center study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A monocentric prospective before-after study on patients carried out in chronic pain department of the CHU Sud Reunion. Patients will be evaluated for inclusion in the study, and will complete the 3-month music intervention. Participants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month. Before starting the musicotherapy program, retrospective data will be collected on the month prior regarding migraine attacks (frequency, severity, duration, treatment intake).
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of Migraine Attacks (Number of Days Per Month)
time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
description: All data related to migraine like frequency, duration, severity are to be collected in a diary questionnaire. Per ANAES (Agence nationale de l'accréditation et de l'évaluation en santé) recommendations, this means reduction of 50% on frequency of migraine attacks after 3-month treatment period. Comparison will be done between the number of days in the month prior the first music intervention and the number of days in the 3rd month of intervention.
measure: Duration of Migraine Attacks (Hours)
time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
description: The outcome is the mean duration of migraine attacks per month. Comparison will be done between the month prior the first music intervention and the 3rd month of intervention. The mean duration is calculated by summing the total duration during the month divided by the number of attacks in the month.
measure: Number of Migraine Episodes With Severe Intensity
time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
description: This data is collected as mild, moderate or severe. The same analysis as the primary outcome will be done by severity. So the frequency of migraine attacks will be compared for each severity.
measure: Impact of Migraines on Everyday Level of Functioning
time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
description: This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. A higher score indicates a worse impact of migraines on daily life. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.
measure: Reduction on Anxiety and Depression
time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
description: This outcome will be evaluated using Hospital Anxiety and Depression Scale (HAD). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.
arm group label: Music intervention
arm group type: Other
description: The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
intervention type: Other
intervention name: Music Therapy
description: The music intervention is administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the "U" technique designed to gradually relax the listener. The "U" technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.
Participants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.
arm group label: Music intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Guilhem PARLONGUE, PhD
role: Principal Investigator
facility: 
country: Réunion
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: Guetin S, Portet F, Picot MC, Defez C, Pose C, Blayac JP, Touchon J. [Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Encephale. 2009 Feb;35(1):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French.
PMID: 19250995
citation: Meister M, Einsle R, Brunner J, Rhyner K. [Psychofonia--a neurophysiologic music therapy in migraine]. Praxis (Bern 1994). 1999 May 20;88(21):946-9. German.
PMID: 10412281
citation: Koenig J, Oelkers-Ax R, Kaess M, Parzer P, Lenzen C, Hillecke TK, Resch F. Specific music therapy techniques in the treatment of primary headache disorders in adolescents: a randomized attention-placebo-controlled trial. J Pain. 2013 Oct;14(10):1196-207. doi: 10.1016/j.jpain.2013.05.006. Epub 2013 Jul 19.
PMID: 23876282
citation: Oelkers-Ax R, Leins A, Parzer P, Hillecke T, Bolay HV, Fischer J, Bender S, Hermanns U, Resch F. Butterbur root extract and music therapy in the prevention of childhood migraine: an explorative study. Eur J Pain. 2008 Apr;12(3):301-13. doi: 10.1016/j.ejpain.2007.06.003. Epub 2007 Jul 30.
PMID: 17659990
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
sharing ipd: No
ipd description: This is not planned to share individual subjects data to other people.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No control group
Future studies to explore music intervention compared to other therapeutic options
results to be interpreted with caution as headache symptoms are self-collected
point of contact: 