Exploratory Study on Global Reflexology in Sickle Cell Disease

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Pain score T20 with the Face Legs Activity Cry Consolability scale [Срок оценки: 20 minutes after the start of the session]
• Pain score T20 with the Visual Analog Scale [Срок оценки: 20 minutes after the start of the session]

Вторичные конечные точки (11)

• Pain score T80 with the Visual Analog Scale [Срок оценки: 80 MINUTES after the start of the session]
• Pain score T80 with the Face Legs Activity Cry Consolability scale [Срок оценки: 80 minutes after the start of the session]
• Length of hospitalization [Срок оценки: 1 Month]
• Number of reflexology sessions [Срок оценки: 1 Month]
• Recorded side effects, complications [Срок оценки: 1 Month]
• Acceptability of the technique : refusal to participate. [Срок оценки: 25 Months]
• Acceptability of the technique: reason for refusal to participate. [Срок оценки: 25 months]
• Acceptability of the technique: interruption of participation. [Срок оценки: 25 months]
• Acceptability of the technique: reason for interruption of participation [Срок оценки: 25 months]
• Feasibility of the technique [Срок оценки: 25 months]
• Inclusion rate [Срок оценки: 25 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital Femme Mère Enfant — Bron

Идентификаторы

NCT: NCT06619197 · 69HCL22_0315 · 2023-A01667-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗