Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises
研究概览
简要总结
Treatment of painful vaso-occlusive crises, the most common manifestation of sickle cell disease, is notoriously limited. vaso-occlusive crises pain is multifactorial with a psychological component. The hypothesis is that the music therapy program MUSIC CARE® can help alleviate severe vaso-occlusive crises pain in synergy with traditional treatment in sickle cell disease patients. The main objective of this prospective, randomized, open label study is to test the effect of the music therapy program MUSIC CARE® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises.
详细描述
Sickle cell disease, the most frequent monogenic disease in France and in the world, is induced by a mutation in the β-globin chain of hemoglobin with production of hemoglobin S. The course of the disease is characterized by very painful, for which treatment is notoriously limited. vaso-occlusive crises pain is multifactorial with biological and psychological components. A few studies suggest a beneficial effect of relaxation techniques in the management of Sickle cell disease pain. MUSIC CARE® is a novative music therapy program which proved efficient in different models of acute or chronic pain. the hypothesis is that this program can help alleviate severe pain in synergy with traditional treatment in SS Sickle cell disease patients, via a dual biological and psychological effect. The main objective of this prospective, randomized, open label study is to test the effect of the music therapy program MUSIC CARE® on daily mean morphine consumption during the 3 first days of hospitalisation for severe vaso-occlusive crises in adult SS Sickle cell disease patients. Secondary outcomes will include mean daily Visual Analogic Scale during the first 3 days of hospitalization for severe vaso-occlusive crises, acute complications of vaso-occlusive crises, duration of severe vaso-occlusive crises and of hospitalization, Hospital Anxiety and Depression Scale.
20 patients will be included in each group for this pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •patients with homozygous Sickle Cell Disease (HbSS,or HbSß0) confirmed by laboratory center
- •hospitalized for severe vaso-occlusive crisis
- •Visual Analogic Scale≥6 at entry
- •able to speak and write French
- •Patient in physical and clinical capacity of consent (signature of the informed consent of the patient or in the presence of a third party)
- •affiliated to a social insurance; not subject to a legal protection
排除标准
- •other hemoglobinopathy
- •pregnancy or post-scriptum (40 days after labor)
- •antecedent of Reflex Epilepsies
- •major hypoacusia
- •Patients already engaged in a therapeutic protocol or in the period of exclusion after a previous interventional research.
研究组 & 干预措施
non interventional arm
Standard Of Care
干预措施: standard care of vaso-occlusive crises (Other)
interventional arm
Standard of Care + music therapy program MUSIC CARE®
干预措施: Music therapy program MUSIC CARE® + standard care (Other)
结局指标
主要结局
Daily mean morphine consumption during the first 3 days of hospitalization for severe vaso-occlusive crises
时间窗: End of the third day of hospitalization for severe vaso-occlusive crises
The total morphine consumption will be calculated for the first 3 days of hospitalization by a doctor, and a mean daily consumption will be calculated.
次要结局
未报告次要终点