Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT03763058
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2018-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Music Intervention on Migraine Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'guilhem_parlongue@hotmail.com', 'phone': '00262262912037', 'title': 'Dr Guilhem Parlongue', 'organization': "Centre d'Evaluation et Traitement de la Douleur"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* No control group\n* Future studies to explore music intervention compared to other therapeutic options\n* results to be interpreted with caution as headache symptoms are self-collected'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Migraine Attacks (Number of Days Per Month)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '8.45', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '5.65', 'spread': '3.73', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.19', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.", 'unitOfMeasure': 'Number of migraine per months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Migraine Attacks (Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '10.95', 'spread': '16.84', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '5.5', 'spread': '7.47', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.45', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.52', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Migraine Episodes With Severe Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '2.9', 'spread': '3.81', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.72', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.71', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.', 'unitOfMeasure': 'Number of episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.'}, {'type': 'SECONDARY', 'title': 'Impact of Migraines on Everyday Level of Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '62.75', 'spread': '6.12', 'groupId': 'OG000'}]}]}, {'title': 'Posttreatment', 'categories': [{'measurements': [{'value': '59.1', 'spread': '6.78', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.65', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.59', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Difference between post and pre-treatment'}, {'type': 'SECONDARY', 'title': 'Reduction on Anxiety and Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'classes': [{'title': 'Anxiety HAD pre-treatment', 'categories': [{'measurements': [{'value': '9.05', 'spread': '3.75', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety HAD post-treatment', 'categories': [{'measurements': [{'value': '7.4', 'spread': '3.79', 'groupId': 'OG000'}]}]}, {'title': 'Depression HAD pre-treatment', 'categories': [{'measurements': [{'value': '6.45', 'spread': '3.88', 'groupId': 'OG000'}]}]}, {'title': 'Depression HAD post-treatment', 'categories': [{'measurements': [{'value': '4', 'spread': '3.46', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.1', 'groupDescription': 'Total HAD score', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited in Groupe Hospitalier Sud Réunion between 3-15 December 2018.', 'preAssignmentDetails': 'Thirty-two patients were screened but not enrolled and assigned to music intervention as they did not fill the inclusion/exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Music Intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.\n\nMusic 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.\n\nParticipants completed 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Réunion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-21', 'size': 1002172, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-01T04:14', 'hasProtocol': True}, {'date': '2018-11-15', 'size': 296350, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-01T04:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2018-11-30', 'resultsFirstSubmitDate': '2019-05-01', 'studyFirstSubmitQcDate': '2018-12-01', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-01', 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Migraine Attacks (Number of Days Per Month)', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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."}], 'secondaryOutcomes': [{'measure': 'Duration of Migraine Attacks (Hours)', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.'}, {'measure': 'Number of Migraine Episodes With Severe Intensity', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.'}, {'measure': 'Impact of Migraines on Everyday Level of Functioning', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.'}, {'measure': 'Reduction on Anxiety and Depression', 'timeFrame': '1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Headache', 'Music intervention', 'Pain', 'Smartphone application'], 'conditions': ['Migraine Headache']}, 'referencesModule': {'references': [{'pmid': '22001666', 'type': 'RESULT', '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.'}, {'pmid': '19250995', 'type': 'RESULT', '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."}, {'pmid': '10412281', 'type': 'RESULT', '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.'}, {'pmid': '23876282', 'type': 'RESULT', '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.'}, {'pmid': '17659990', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTherefore, 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.\n\nThe 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).\n\nThis is a pilot study, non-randomized, single arm and single center study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with episodic migraine with at least 4 attacks per month\n* Patients with migraines with or without aura with diagnostic criteria per International Headache Society\n* Patients with a migraine for more than one year\n* Diagnosis age \\< 50 years\n* Patients with an available internet connexion to access Music Care application\n* Patients with minimal knowledge in informatics\n* Patients who sign their inform consent\n\nExclusion Criteria:\n\n* Patients aged less than 18 years\n* Patients with chronic migraine\n* Patients with epilepsy\n* Patients with a deficiency on auditive function\n* Patients with a disease that could be fatal within the study period.'}, 'identificationModule': {'nctId': 'NCT03763058', 'acronym': 'CHU', 'briefTitle': 'Music Intervention on Migraine Headaches', 'organization': {'class': 'OTHER', 'fullName': 'Association de Musicothérapie Applications et Recherches Cliniques'}, 'officialTitle': 'The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial', 'orgStudyIdInfo': {'id': 'MusicMig'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Music intervention', 'description': 'The music intervention is administered via a smartphone- (and computer-) based application called Music Care.', 'interventionNames': ['Other: Music Therapy']}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', '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.\n\nParticipants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month.', 'armGroupLabels': ['Music intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97448', 'city': 'Saint-Pierre', 'country': 'Reunion', 'facility': 'CHU de la Réunion', 'geoPoint': {'lat': -21.3393, 'lon': 55.47811}}], 'overallOfficials': [{'name': 'Guilhem PARLONGUE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not planned to share individual subjects data to other people.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association de Musicothérapie Applications et Recherches Cliniques', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}