NCT03639805

Music Therapy in Sickle Cell Disease Vaso-occlusive Crisis

Effect of a Music Therapy Program on Vaso-occlusive Crisis Pain in Sickle Cell Disease Patients: A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vaso-occlusive Crisis

Interventions

Type	Name	Description
OTHER	Music therapy program MUSIC CARE® + standard care	Administration of a specific music therapy program (U method) delivered through headphones from an iPad, under the direction of trained nurses. The program will be proposed 3 times a day and will last 20 minutes at each session.
OTHER	standard care of vaso-occlusive crises	administration of standard care only

Timeline

• Start date: 2018-09-28
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2018-08-21
• Last updated: 2019-10-21

Locations

1 site across 1 country: France