Music Intervention on Migraine Headaches (CHU)
Primary Purpose
Migraine Headache
Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring Migraine, Headache, Music intervention, Pain, Smartphone application
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.
Sites / Locations
- CHU de la Réunion
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Music intervention
Arm Description
The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of Migraine Attacks (Hours)
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.
Number of Migraine Episodes With Severe Intensity
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.
Impact of Migraines on Everyday Level of Functioning
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.
Reduction on Anxiety and Depression
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.
Full Information
NCT ID
NCT03763058
First Posted
November 30, 2018
Last Updated
July 21, 2019
Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Collaborators
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT03763058
Brief Title
Music Intervention on Migraine Headaches
Acronym
CHU
Official Title
The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association de Musicothérapie Applications et Recherches Cliniques
Collaborators
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine, Headache, Music intervention, Pain, Smartphone application
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music intervention
Arm Type
Other
Arm Description
The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Frequency of Migraine Attacks (Number of Days Per Month)
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.
Time Frame
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Secondary Outcome Measure Information:
Title
Duration of Migraine Attacks (Hours)
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.
Time Frame
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Title
Number of Migraine Episodes With Severe Intensity
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.
Time Frame
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Title
Impact of Migraines on Everyday Level of Functioning
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.
Time Frame
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Title
Reduction on Anxiety and Depression
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.
Time Frame
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilhem PARLONGUE, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is not planned to share individual subjects data to other people.
Citations:
PubMed Identifier
22001666
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.
Results Reference
result
PubMed Identifier
19250995
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.
Results Reference
result
PubMed Identifier
10412281
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.
Results Reference
result
PubMed Identifier
23876282
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.
Results Reference
result
PubMed Identifier
17659990
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.
Results Reference
result
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Music Intervention on Migraine Headaches
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