Exploratory Study on Global Reflexology in Sickle Cell Disease

NCT06619197 | Recruiting

• 2 other identifiers: 69HCL22_03152023-A01667-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease (SCD)

Keywords

Reflexology; Pain; sickle cell disease

Outcome Measures

Primary Outcomes (2)

• Pain score T20 with the Face Legs Activity Cry Consolability scale

  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

  20 minutes after the start of the session

• Pain score T20 with the Visual Analog Scale

  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

  20 minutes after the start of the session

Secondary Outcomes (11)

• Pain score T80 with the Visual Analog Scale

  80 MINUTES after the start of the session

• Pain score T80 with the Face Legs Activity Cry Consolability scale

  80 minutes after the start of the session

• Length of hospitalization

  1 Month

• Number of reflexology sessions

  1 Month

• Recorded side effects, complications

  1 Month

Study Arms (1)

global reflexology

OTHER

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.

Other: Global reflexology

Interventions

Global reflexology OTHER

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.

global reflexology

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• COLLOT SOPHIE

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

COLLOT Sophie

CONTACT

0033472115165; sophie.collot@chu-lyon.fr

HAESEBAERT Julie, MD

CONTACT

0033472115165; julie.haesebaert01@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective exploratory study of single-center feasibility. Research involving human subjects 2. This feasibility study will estimate the improvement in pain provided by reflexology, acceptability and feasibility, rate of inclusion. The research will take place in 2 centers, the short-stay hospitalization unit (UHCD) and the continuous monitoring unit (USC) of the Women\'s Mother and Child Hospital of the Hospices Civils de Lyon. This study involves subjects under 18 years of age, suffering from sickle cell disease, hospitalized in the unit UHCD or the unit USC.

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 1, 2024
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

FR (1)