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Music Intervention on Migraine Headaches (CHU)

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ClinicalTrials.gov Identifier: NCT03763058
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de la Réunion
Information provided by (Responsible Party):
Association de Musicothérapie Applications et Recherches Cliniques

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Headache Other: Music Therapy Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Music intervention
The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
Other: Music Therapy

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.





Primary Outcome Measures :
  1. Frequency of migraine attacks (number of days per month) [ Time Frame: 3 months ]
    All data related to migraine like frequency, duration, severely are to be collected in a diary questionnaire. Per ANAES 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.


Secondary Outcome Measures :
  1. Duration of migraine attacks (hours) [ Time Frame: 3 months ]
    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.

  2. Intensity of migraine attacks [ Time Frame: 3 months ]
    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.

  3. Impact of migraines on everyday level of functioning [ Time Frame: 3 months ]
    This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. Higher is the score more important is the impact of migraine 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.

  4. Reduction on anxiety and depression [ Time Frame: 3 months ]
    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. Higher is the score more important are the 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with episodic migraine with at least 4 attacks per month
  • Patients with migraines with or without aura with diagnostic criteria per International Headache Society
  • Patients with a migraine for more than one year
  • Diagnosis age < 50 years
  • Patients with an available internet connexion to access Music Care application
  • Patients with minimal knowledge in informatics
  • Patients who sign their inform consent

Exclusion Criteria:

  • Patients aged less than 18 years
  • Patients with chronic migraine
  • Patients with epilepsy
  • Patients with a deficiency on auditive function
  • Patients with a disease that could be fatal within the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763058


Contacts
Contact: Guilhem PARLONGUE, PhD +2622 62 91 20 37 guilhem_parlongue@hotmail.com
Contact: Emmanuelle VUILLAUME CERDAN emmanuelle.vuillaume-cerdan@chu-reunion.fr

Locations
Réunion
CHU de la Réunion Recruiting
Saint-Pierre, Réunion, 97448
Contact: Guilhem PARLONGUE, PhD    002622 62 91 20 37    guilhem_parlongue@hotmail.com   
Contact: Emmanuelle VUILLAUME CERDAN, PhD       emmanuelle.vuillaume-cerdan@chu-reunion.fr   
Sponsors and Collaborators
Association de Musicothérapie Applications et Recherches Cliniques
Centre Hospitalier Universitaire de la Réunion
Investigators
Principal Investigator: Guilhem PARLONGUE, PhD

Publications of Results:
Responsible Party: Association de Musicothérapie Applications et Recherches Cliniques
ClinicalTrials.gov Identifier: NCT03763058     History of Changes
Other Study ID Numbers: MusicMig
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not planned to share individual subjects data to other people.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Association de Musicothérapie Applications et Recherches Cliniques:
Migraine
Headache
Music intervention
Pain
Smartphone application

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms