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

Exploratory Study on Global Reflexology Proposed in the Management of Pain in Children With Sickle Cell Disease in Vaso-occlusive Crisis

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease (SCD)
• Intervention / Treatment: Other: Global reflexology

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: COLLOT Sophie; Phone Number: 0033472115165; Email: sophie.collot@chu-lyon.fr
• Study Contact Backup: Name: HAESEBAERT Julie, MD; Phone Number: 0033472115165; Email: julie.haesebaert01@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hôpital Femme Mère Enfant
    • Contact: COLLOT SOPHIE; Phone Number: 0033472855577; Email: sophie.collot@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: global reflexology; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score T80 with the Visual Analog Scale	Changes in pain scores (VAS - Visual Analog Scale according to the child's age) at each session between T0 and T80 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	80 MINUTES after the start of the session
Pain score T80 with the Face Legs Activity Cry Consolability scale	Changes in pain scores (Face Legs Activity Cry Consolability according to the child's age) at each session between T0 and T80 minutes after the start of the sessionmn. 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	80 minutes after the start of the session
Length of hospitalization	Length of stay of patients included in the study, defined by the time between their entry into the UHCD or USC and their return home.	1 Month
Number of reflexology sessions	Total number of global reflexology sessions performed for each child included in the study.	1 Month
Recorded side effects, complications	Recorded side effects, complications	1 Month
Acceptability of the technique : refusal to participate.	Acceptability of the technique: number of refusals to participate in the protocol during the study.	25 Months
Acceptability of the technique: reason for refusal to participate.	Acceptability of the technique: reasons of refusals to participate in the protocol during the study.	25 months
Acceptability of the technique: interruption of participation.	Acceptability of the technique: number of requests for interruption during the study.	25 months
Acceptability of the technique: reason for interruption of participation	Acceptability of the technique: reasons for discontinuations for requests of interruption during the study.	25 months
Feasibility of the technique	Feasibility of the technique: integration into the management of CVO: number of sessions not performed or interrupted and reasons, duration of sessions.	25 months
Inclusion rate	Monthly inclusion rate in the study, characteristics of the eligible population, included and not included.	25 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: COLLOT SOPHIE, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Reflexology; sickle cell disease
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: 69HCL22_0315; 2023-A01667-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No