Exploratory Study on Global Reflexology Proposed in the Management of Pain in Children With Sickle Cell Disease in Vaso-occlusive Crisis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain score T20 with the Face Legs Activity Cry Consolability scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain score T20 with the Face Legs Activity Cry Consolability scale
时间窗: 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
Pain score T20 with the Visual Analog Scale
时间窗: 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
次要结局
- 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)
- Acceptability of the technique : refusal to participate.(25 Months)
- Feasibility of the technique(25 months)
- Inclusion rate(25 months)
- Acceptability of the technique: reason for refusal to participate.(25 months)
- Acceptability of the technique: interruption of participation.(25 months)
- Acceptability of the technique: reason for interruption of participation(25 months)