Exploratory Study on Global Reflexology in Sickle Cell Disease (REFLEXODREPANO)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Sickle Cell Disease (SCD)

Treatments: Other: Global reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT06619197

69HCL22_0315

2023-A01667-38 (Other Identifier)

Details and patient eligibility

About

Sickle cell disease (or sickle cell anemia) is the most common genetic disease in France with 586 children screened in 2019. This chronic disease is characterized by the presence of abnormal Hemoglobin (Hb) S and a deformation of the red blood cells which take the elongated shape of a sickle and become more rigid and more fragile. Sickle cell disease manifests itself among other things by very painful vaso-occlusive crises (VOC) and for some chronic pain.

Their management is an emergency and often requires hospitalization. Despite analgesic treatment, some patients have persistent pain.

In 2013, a childcare assistant trained in Canadian global reflexology EMC offered reflexology sessions to 12 sickle cell patients. She observed a relief in all patients with a decrease in the pain score in 8 of them. These sessions seem to show us a double interest: the reduction of the child's pain and the emergence of a technique that can be used by paramedics in the context of their own role.

The investgators hypothesize that global reflexology is an effective and acceptable complementary technique for pain management in addition to the usual analgesic management in sickle cell children under 18 years of age in CVO. In order to verify our hypothesis, the investigators propose to explore the practice of Canadian global reflexology as an innovative therapeutic option complementary to drug treatments in the hospital management of sickle cell children.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient under 18 years of age
• Patient suffering from sickle cell disease
• Patient hospitalized in the UHCD or USC unit of the Women's Mother and Child Hospital of the Hospices Civils de Lyon for the management of a CVO
• Informed consent signed by at least one holder of parental authority
• Collection of the patient's assent as soon as his age allows it.

Exclusion criteria

• Patient with PCA (Patient Controlled Analgesia)
• Patient with NCA (Nurse Controlled Analgesia)
• Patient not affiliated to a social security scheme or beneficiaries of a similar scheme.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

global reflexology

Other group

Description:

This study involves subjects under 18 years of age, suffering from sickle cell disease, hospitalized in the short-stay hospitalization unit (UHCD) or continuous monitoring unit (USC) of the Women's Mother and Child Hospital of the Hospices Civils de Lyon.

Treatment:

Other: Global reflexology