Clinical trial NCT06619197: Exploratory Study on Global Reflexology in Sickle Cell Disease
Official title: Exploratory Study on Global Reflexology Proposed in the Management of Pain in Children With Sickle Cell Disease in Vaso-occlusive Crisis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease (SCD)
Keywords: Reflexology
Pain
sickle cell disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective exploratory study of single-center feasibility. Research involving human subjects 2. This feasibility study will estimate the improvement in pain provided by reflexology, acceptability and feasibility, rate of inclusion.

The research will take place in 2 centers, the short-stay hospitalization unit (UHCD) and the continuous monitoring unit (USC) of the Women\&#39;s Mother and Child Hospital of the Hospices Civils de Lyon.

This study involves subjects under 18 years of age, suffering from sickle cell disease, hospitalized in the unit UHCD or the unit USC.
Primary purpose: SUPPORTIVE_CARE

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\&amp;#39;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: 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\&#39;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\&#39;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.

Primary outcomes:
measure: Pain score T20 with the Face Legs Activity Cry Consolability scale
timeFrame: 20 minutes after the start of the session
measure: Pain score T20 with the Visual Analog Scale
timeFrame: 20 minutes after the start of the session
Secondary outcomes:
measure: Pain score T80 with the Visual Analog Scale
timeFrame: 80 MINUTES after the start of the session
measure: Pain score T80 with the Face Legs Activity Cry Consolability scale
timeFrame: 80 minutes after the start of the session
measure: Length of hospitalization
timeFrame: 1 Month
measure: Number of reflexology sessions
timeFrame: 1 Month
measure: Recorded side effects, complications
timeFrame: 1 Month
measure: Acceptability of the technique : refusal to participate.
timeFrame: 25 Months
measure: Acceptability of the technique: reason for refusal to participate.
timeFrame: 25 months
measure: Acceptability of the technique: interruption of participation.
timeFrame: 25 months
measure: Acceptability of the technique: reason for interruption of participation
timeFrame: 25 months
measure: Feasibility of the technique
timeFrame: 25 months
measure: Inclusion rate
timeFrame: 25 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: COLLOT SOPHIE
role: PRINCIPAL_INVESTIGATOR
References: