Migraine Headache
Conditions
Keywords
Migraine, Headache, Music intervention, Pain, Smartphone application
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.
Interventions
OTHERMusic 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.
Sponsors
Centre Hospitalier Universitaire de la Réunion
Association de Musicothérapie Applications et Recherches Cliniques
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Migraine Attacks (Number of Days Per Month) | 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment) | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Migraine Attacks (Hours) | 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment) | 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 | 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment) | 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 | 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment) | 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 | 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment) | 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. |
Countries
Reunion
Participant flow
Recruitment details
Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.
Pre-assignment details
Thirty-two patients were screened but not enrolled and assigned to music intervention as they did not fill the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Music Intervention The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
Music Therapy: The music intervention was 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 completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Music Intervention | — |
|---|---|---|
| Age, Continuous | 42 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Réunion | 20 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Intervention | Frequency of Migraine Attacks (Number of Days Per Month) | Pre-treatment | 8.45 Number of migraine per months | Standard Deviation 3.03 |
| Music Intervention | Frequency of Migraine Attacks (Number of Days Per Month) | Post-treatment | 5.65 Number of migraine per months | Standard Deviation 3.73 |
p-value: 0.012Sign test
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Intervention | Duration of Migraine Attacks (Hours) | Pre-treatment | 10.95 Hours | Standard Deviation 16.84 |
| Music Intervention | Duration of Migraine Attacks (Hours) | Post-treatment | 5.5 Hours | Standard Deviation 7.47 |
p-value: 0.002Sign test
Secondary
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)
Population: Difference between post and pre-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Intervention | Impact of Migraines on Everyday Level of Functioning | Pre-treatment | 62.75 score on a scale | Standard Deviation 6.12 |
| Music Intervention | Impact of Migraines on Everyday Level of Functioning | Posttreatment | 59.1 score on a scale | Standard Deviation 6.78 |
p-value: <0.001Sign test
Secondary
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)
Population: Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Intervention | Number of Migraine Episodes With Severe Intensity | Pre-treatment | 2.9 Number of episodes | Standard Deviation 3.81 |
| Music Intervention | Number of Migraine Episodes With Severe Intensity | Post-treatment | 1.7 Number of episodes | Standard Deviation 1.72 |
p-value: 0.045Sign test
Secondary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Intervention | Reduction on Anxiety and Depression | Anxiety HAD pre-treatment | 9.05 score on a scale | Standard Deviation 3.75 |
| Music Intervention | Reduction on Anxiety and Depression | Anxiety HAD post-treatment | 7.4 score on a scale | Standard Deviation 3.79 |
| Music Intervention | Reduction on Anxiety and Depression | Depression HAD pre-treatment | 6.45 score on a scale | Standard Deviation 3.88 |
| Music Intervention | Reduction on Anxiety and Depression | Depression HAD post-treatment | 4 score on a scale | Standard Deviation 3.46 |
Comparison: Total HAD scorep-value: <0.001Sign test