Exploratory Study on Global Reflexology in Sickle Cell Disease
ConditionSickle Cell Disease (SCD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Global reflexology
Other interventionThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: global reflexologyOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain score T20 with the Face Legs Activity Cry Consolability scale
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
Time frame
20 minutes after the start of the session2
Pain score T20 with the Visual Analog Scale
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
Time frame
20 minutes after the start of the sessionSecondary outcomes
1
Pain score T80 with the Visual Analog Scale
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
Time frame
80 MINUTES after the start of the session2
Pain score T80 with the Face Legs Activity Cry Consolability scale
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
Time frame
80 minutes after the start of the session3
Length of hospitalization
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.
Time frame
1 Month4
Number of reflexology sessions
Total number of global reflexology sessions performed for each child included in the study.
Time frame
1 MonthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov