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Recruiting Not applicable

Exploratory Study on Global Reflexology in Sickle Cell Disease

NCT06619197 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-06-30
Last updated
2025-07-08

Condition(s) studied

Sickle Cell Disease (SCD)

Investigational drug(s) / intervention(s)

Global reflexology

Global reflexology: The EMC method is a global reflexology technique inspired by the work of the American naturopath Stanley Burrough (Vitaflex, 1976). It is a method of reflexology on the whole body, of acupressure massages (rhythmic and targeted movements) on so-called \"reflex\" zones which is practiced on different areas of the body (feet, hands, arms, legs, collarbone, ear) and allows the stimulation of all systems.

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pain score T20 with the Face Legs Activity Cry Consolability scale — 20 minutes after the start of the session
    Evolution of pain scores (Face Legs Activity Cry Consolability - FLACC according to the child\'s age) T0 and T20 minutes after the start of the session. The minimum value is 0 (no pain) and the maximum is 10 (maximum pain). All professionals are trained in the use of the FLACC pain scale
  • Pain score T20 with the Visual Analog Scale — 20 minutes after the start of the session
    Evolution of pain scores (VAS - Visual Analog Scale according to the child\'s age) T0 and T20 minutes after the start of the session. The minimum value is 0 (no pain) and the maximum is 10 (maximum pain). All professionals are trained in the use of the VAS pain scale

Trial sites (1)

FacilityCityRegionStatus
Hôpital Femme Mère Enfant Bron France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619197 on ClinicalTrials.gov ↗ ← All trials in France