The Effect of Music Therapy on Episodic Migraine Patients Under the Care of Chronic Pain Department - A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Frequency of Migraine Attacks (Number of Days Per Month)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Music intervention
The music intervention is administered via a smartphone- (and computer-) based application called Music Care.
干预措施: Music Therapy (Other)
结局指标
主要结局
Frequency of Migraine Attacks (Number of Days Per Month)
时间窗: 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.
次要结局
- Number of Migraine Episodes With Severe Intensity(1 month prior to intervention (pre-treatment) up to 3 months (post-treatment))
- Reduction on Anxiety and Depression(1 month prior to intervention (pre-treatment) up to 3 months (post-treatment))
- Duration of Migraine Attacks (Hours)(1 month prior to intervention (pre-treatment) up to 3 months (post-treatment))
- Impact of Migraines on Everyday Level of Functioning(1 month prior to intervention (pre-treatment) up to 3 months (post-treatment))