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NCT03763058: CHU

Music Intervention on Migraine Headaches

Completed NA Results posted Last updated 2 August 2019
What this trial tests

NA trial testing Music Therapy in Migraine Headache in 20 participants. Completed in 15 March 2019.

Timeline
3 December 2018
Primary endpoint
15 March 2019
15 March 2019

Quick facts

Lead sponsorAssociation de Musicothérapie Applications et Recherches Cliniques
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date3 December 2018
Primary completion15 March 2019
Estimated completion15 March 2019
Sites1 location across Reunion

Drugs / interventions tested

Conditions studied

Sponsor

Association de Musicothérapie Applications et Recherches Cliniques

Who can join

Adults 18 to 65, any sex, with Migraine Headache. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Migraine Attacks (Number of Days Per Month) Primary · 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.

Pre-treatment
GroupValue95% CI
Music Intervention8.45± 3.03
Post-treatment
GroupValue95% CI
Music Intervention5.65± 3.73
Duration of Migraine Attacks (Hours) Secondary · 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.

Pre-treatment
GroupValue95% CI
Music Intervention10.95± 16.84
Post-treatment
GroupValue95% CI
Music Intervention5.5± 7.47
Number of Migraine Episodes With Severe Intensity Secondary · 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.

Pre-treatment
GroupValue95% CI
Music Intervention2.9± 3.81
Post-treatment
GroupValue95% CI
Music Intervention1.7± 1.72
Impact of Migraines on Everyday Level of Functioning Secondary · 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.

Pre-treatment
GroupValue95% CI
Music Intervention62.75± 6.12
Posttreatment
GroupValue95% CI
Music Intervention59.1± 6.78
Reduction on Anxiety and Depression Secondary · 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.

Anxiety HAD pre-treatment
GroupValue95% CI
Music Intervention9.05± 3.75
Anxiety HAD post-treatment
GroupValue95% CI
Music Intervention7.4± 3.79
Depression HAD pre-treatment
GroupValue95% CI
Music Intervention6.45± 3.88
Depression HAD post-treatment
GroupValue95% CI
Music Intervention4± 3.46

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Music Therapy

Trials testing the same drug.

Other recruiting trials for Migraine Headache

Currently open trials in the same condition.

Other Association de Musicothérapie Applications et Recherches Cliniques trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03763058.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing