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NCT Number: NCT06619197

Exploratory Study on Global Reflexology in Sickle Cell Disease

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.

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Key information

Conditions

Sickle Cell Disease (SCD) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain score T20 with the Face Legs Activity Cry Consolability scale

    Time frame: 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

  2. Pain score T20 with the Visual Analog Scale

    Time frame: 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

Secondary outcomes

  1. Pain score T80 with the Visual Analog Scale

    Time frame: 80 MINUTES after the start of the session

    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

  2. Pain score T80 with the Face Legs Activity Cry Consolability scale

    Time frame: 80 minutes after the start of the session

    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

  3. Length of hospitalization

    Time frame: 1 Month

    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.

  4. Number of reflexology sessions

    Time frame: 1 Month

    Total number of global reflexology sessions performed for each child included in the study.

  5. Recorded side effects, complications

    Time frame: 1 Month

    Recorded side effects, complications

  6. Acceptability of the technique : refusal to participate.

    Time frame: 25 Months

    Acceptability of the technique: number of refusals to participate in the protocol during the study.

  7. Acceptability of the technique: reason for refusal to participate.

    Time frame: 25 months

    Acceptability of the technique: reasons of refusals to participate in the protocol during the study.

  8. Acceptability of the technique: interruption of participation.

    Time frame: 25 months

    Acceptability of the technique: number of requests for interruption during the study.

  9. Acceptability of the technique: reason for interruption of participation

    Time frame: 25 months

    Acceptability of the technique: reasons for discontinuations for requests of interruption during the study.

  10. Feasibility of the technique

    Time frame: 25 months

    Feasibility of the technique: integration into the management of CVO: number of sessions not performed or interrupted and reasons, duration of sessions.

  11. Inclusion rate

    Time frame: 25 months

    Monthly inclusion rate in the study, characteristics of the eligible population, included and not included.

Study contacts

Contact information is provided by the study sponsor or research team.

COLLOT Sophie

CONTACT

[email protected]

0033472115165

HAESEBAERT Julie, MD

CONTACT

[email protected]

0033472115165

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: REFLEXODREPANO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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