Trial Outcomes & Findings for Music Intervention on Migraine Headaches (NCT NCT03763058)
NCT ID: NCT03763058
Last Updated: 2019-08-02
Results Overview
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.
COMPLETED
NA
20 participants
1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)
2019-08-02
Participant Flow
Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.
Thirty-two patients were screened but not enrolled and assigned to music intervention as they did not fill the inclusion/exclusion criteria.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Age, Continuous
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42 years
n=20 Participants
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Sex: Female, Male
Female
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17 Participants
n=20 Participants
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Sex: Female, Male
Male
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3 Participants
n=20 Participants
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Region of Enrollment
Réunion
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20 participants
n=20 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Frequency of Migraine Attacks (Number of Days Per Month)
Pre-treatment
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8.45 Number of migraine per months
Standard Deviation 3.03
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Frequency of Migraine Attacks (Number of Days Per Month)
Post-treatment
|
5.65 Number of migraine per months
Standard Deviation 3.73
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Duration of Migraine Attacks (Hours)
Pre-treatment
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10.95 Hours
Standard Deviation 16.84
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Duration of Migraine Attacks (Hours)
Post-treatment
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5.5 Hours
Standard Deviation 7.47
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SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Number of Migraine Episodes With Severe Intensity
Pre-treatment
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2.9 Number of episodes
Standard Deviation 3.81
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Number of Migraine Episodes With Severe Intensity
Post-treatment
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1.7 Number of episodes
Standard Deviation 1.72
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SECONDARY outcome
Timeframe: 1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)Population: Difference between post and pre-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.
Outcome measures
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Impact of Migraines on Everyday Level of Functioning
Pre-treatment
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62.75 score on a scale
Standard Deviation 6.12
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Impact of Migraines on Everyday Level of Functioning
Posttreatment
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59.1 score on a scale
Standard Deviation 6.78
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Intervention
n=20 Participants
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.
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|---|---|
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Reduction on Anxiety and Depression
Anxiety HAD pre-treatment
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9.05 score on a scale
Standard Deviation 3.75
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Reduction on Anxiety and Depression
Anxiety HAD post-treatment
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7.4 score on a scale
Standard Deviation 3.79
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Reduction on Anxiety and Depression
Depression HAD pre-treatment
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6.45 score on a scale
Standard Deviation 3.88
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Reduction on Anxiety and Depression
Depression HAD post-treatment
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4 score on a scale
Standard Deviation 3.46
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Adverse Events
Music Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Guilhem Parlongue
Centre d'Evaluation et Traitement de la Douleur
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place