An interventional study of Music Therapy in Migraine Headache, sponsored by Association de Musicothérapie Applications et Recherches Cliniques. Completed at 1 site in Réunion. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Association de Musicothérapie Applications et Recherches Cliniques · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Association de Musicothérapie Applications et Recherches Cliniques is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
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.
Time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
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.
Time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
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.
Time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
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.
Time frame: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.
| Milestone | Music Intervention |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
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.
| Number of migraine per months | Music Intervention |
|---|---|
| Pre-treatment | 8.45 ± 3.03 |
| Post-treatment | 5.65 ± 3.73 |
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.
| Hours | Music Intervention |
|---|---|
| Pre-treatment | 10.95 ± 16.84 |
| Post-treatment | 5.5 ± 7.47 |
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.
| Number of episodes | Music Intervention |
|---|---|
| Pre-treatment | 2.9 ± 3.81 |
| Post-treatment | 1.7 ± 1.72 |
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.
| score on a scale | Music Intervention |
|---|---|
| Pre-treatment | 62.75 ± 6.12 |
| Posttreatment | 59.1 ± 6.78 |
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.
| score on a scale | Music Intervention |
|---|---|
| Anxiety HAD pre-treatment | 9.05 ± 3.75 |
| Anxiety HAD post-treatment | 7.4 ± 3.79 |
| Depression HAD pre-treatment | 6.45 ± 3.88 |
| Depression HAD post-treatment | 4 ± 3.46 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Music Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Music Intervention |
|---|---|
| Mean | 42 (19 to 63) |
| Sex: Female, Male(Participants) | Music Intervention |
|---|---|
| Female | 17 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Music Intervention |
|---|
| Region of Enrollment(participants) | Music Intervention |
|---|---|
| Réunion | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — This is not planned to share individual subjects data to other people.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Association de Musicothérapie Applications et Recherches Cliniques