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Music Intervention on Migraine Headaches (CHU)

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ClinicalTrials.gov Identifier: NCT03763058
Recruitment Status : Completed
First Posted : December 4, 2018
Results First Posted : July 18, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de la Réunion
Information provided by (Responsible Party):
Association de Musicothérapie Applications et Recherches Cliniques

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Headache
Intervention Other: Music Therapy
Enrollment 20
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.
Arm/Group Title Music Intervention
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 18
Not Completed 2
Arm/Group Title Music Intervention
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
42
(19 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
17
  85.0%
Male
3
  15.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Réunion Number Analyzed 20 participants
20
1.Primary Outcome
Title Frequency of Migraine Attacks (Number of Days Per Month)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Music Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Number of migraine per months
Pre-treatment 8.45  (3.03)
Post-treatment 5.65  (3.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Music Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.8
Parameter Dispersion
Type: Standard Deviation
Value: 4.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Duration of Migraine Attacks (Hours)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Music Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Hours
Pre-treatment 10.95  (16.84)
Post-treatment 5.5  (7.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Music Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.45
Parameter Dispersion
Type: Standard Deviation
Value: 15.52
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Migraine Episodes With Severe Intensity
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.
Arm/Group Title Music Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Number of episodes
Pre-treatment 2.9  (3.81)
Post-treatment 1.7  (1.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Music Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Parameter Dispersion
Type: Standard Deviation
Value: 2.71
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Impact of Migraines on Everyday Level of Functioning
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Difference between post and pre-treatment
Arm/Group Title Music Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
Pre-treatment 62.75  (6.12)
Posttreatment 59.1  (6.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Music Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.65
Parameter Dispersion
Type: Standard Deviation
Value: 4.59
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Reduction on Anxiety and Depression
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Music Intervention
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Music Intervention
Comments Total HAD score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Sign test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.15
Parameter Dispersion
Type: Standard Deviation
Value: 5.1
Estimation Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Music Intervention
Hide Arm/Group Description

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.

All-Cause Mortality
Music Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Music Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Music Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
  • 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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Guilhem Parlongue
Organization: Centre d'Evaluation et Traitement de la Douleur
Phone: 00262262912037
EMail: guilhem_parlongue@hotmail.com
Layout table for additonal information
Responsible Party: Association de Musicothérapie Applications et Recherches Cliniques
ClinicalTrials.gov Identifier: NCT03763058     History of Changes
Other Study ID Numbers: MusicMig
First Submitted: November 30, 2018
First Posted: December 4, 2018
Results First Submitted: May 1, 2019
Results First Posted: July 18, 2019
Last Update Posted: August 2, 2019