Exploratory Study on Global Reflexology in Sickle Cell Disease
- Conditions
- Sickle Cell Disease (SCD)
- Interventions
- Other: Global reflexology
- Registration Number
- NCT06619197
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description global reflexology 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.
- Primary Outcome Measures
Name Time Method Pain score T20 with the Face Legs Activity Cry Consolability scale 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 scalePain score T20 with the Visual Analog Scale 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 Outcome Measures
Name Time Method Pain score T80 with the Visual Analog Scale 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
Pain score T80 with the Face Legs Activity Cry Consolability scale 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
Length of hospitalization 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.
Number of reflexology sessions 1 Month Total number of global reflexology sessions performed for each child included in the study.
Recorded side effects, complications 1 Month Recorded side effects, complications
Acceptability of the technique : refusal to participate. 25 Months Acceptability of the technique: number of refusals to participate in the protocol during the study.
Feasibility of the technique 25 months Feasibility of the technique: integration into the management of CVO: number of sessions not performed or interrupted and reasons, duration of sessions.
Inclusion rate 25 months Monthly inclusion rate in the study, characteristics of the eligible population, included and not included.
Acceptability of the technique: reason for refusal to participate. 25 months Acceptability of the technique: reasons of refusals to participate in the protocol during the study.
Acceptability of the technique: interruption of participation. 25 months Acceptability of the technique: number of requests for interruption during the study.
Acceptability of the technique: reason for interruption of participation 25 months Acceptability of the technique: reasons for discontinuations for requests of interruption during the study.
Trial Locations
- Locations (1)
Hôpital Femme Mère Enfant
🇫🇷Bron, France