Clinical trial NCT03763058: Music Intervention on Migraine Headaches
Official title: The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Keywords: Migraine
Headache
Music intervention
Pain
Smartphone application
Lead sponsor: Association de Musicothérapie Applications et Recherches Cliniques
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de la Réunion
First posted: 2018-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Frequency of Migraine Attacks (Number of Days Per Month)
timeFrame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Secondary outcomes:
measure: Duration of Migraine Attacks (Hours)
timeFrame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
measure: Number of Migraine Episodes With Severe Intensity
timeFrame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
measure: Impact of Migraines on Everyday Level of Functioning
timeFrame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
measure: Reduction on Anxiety and Depression
timeFrame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
name: Guilhem PARLONGUE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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.