Music Intervention on Migraine Headaches

NCT03763058 | Completed Results

• 1 other identifier: MusicMig
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

Migraine; Headache; Music intervention; Pain; Smartphone application

Outcome Measures

Primary Outcomes (1)

• Frequency of Migraine Attacks (Number of Days Per Month)

  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.

  1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)

Secondary Outcomes (4)

• Duration of Migraine Attacks (Hours)

  1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)

• Number of Migraine Episodes With Severe Intensity

  1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)

• Impact of Migraines on Everyday Level of Functioning

  1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)

• Reduction on Anxiety and Depression

  1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)

Study Arms (1)

Music intervention

OTHER

The music intervention is administered via a smartphone- (and computer-) based application called Music Care.

Other: Music Therapy

Interventions

Music Therapy OTHER

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.

Music intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Association de Musicothérapie Applications et Recherches Cliniques: lead
• Centre Hospitalier Universitaire de la Réunion: collaborator

Study Sites (1)

CHU de la Réunion

Saint-Pierre, 97448, Reunion

Location

Related Publications (5)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

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

Results Point of Contact

• Title: Dr Guilhem Parlongue
• Organization: Centre d'Evaluation et Traitement de la Douleur

guilhem_parlongue@hotmail.com

00262262912037

Study Officials

• Guilhem PARLONGUE, PhD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: December 3, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: August 2, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)