NCT06619197 Exploratory Study on Global Reflexology in Sickle Cell Disease
| NCT ID | NCT06619197 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Sickle Cell Disease (SCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-30 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
COLLOT SOPHIE
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT06619197 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Sickle Cell Disease (SCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06619197 currently recruiting?
Yes, NCT06619197 is actively recruiting participants. Contact the research team at sophie.collot@chu-lyon.fr for enrollment information.
Where is the NCT06619197 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT06619197 clinical trial?
NCT06619197 is sponsored by Hospices Civils de Lyon. The principal investigator is COLLOT SOPHIE at Hospices Civils de Lyon. The trial plans to enroll 30 participants.
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