Sickle Cell Disease (SCD)REFLEXODREPANONCT06619197
Exploratory Study on Global Reflexology in Sickle Cell Disease
A study testing Global reflexology in people with Sickle Cell Disease (SCD), run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Sickle Cell Disease (SCD)
- What is being tested?
- Global reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Bron, 69500
COLLOT SOPHIE, 0033472855577, sophie.collot@chu-lyon.fr
About this study
Official title: Exploratory Study on Global Reflexology Proposed in the Management of Pain in Children With Sickle Cell Disease in Vaso-occlusive Crisis
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.
Read more
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.
- Conditions
- Sickle Cell Disease (SCD)
- Being tested
- Global reflexology
- Keywords
- Reflexology, Pain, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global reflexologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| global reflexology | Other | 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. Receives: Other: Global reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes after the start of the session
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
Measured: 20 minutes after the start of the session
Secondary outcomes (11)
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
Measured: 80 MINUTES after the start of the session
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
Measured: 80 minutes after the start of the session
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.
Measured: 1 Month
Number of reflexology sessions
Total number of global reflexology sessions performed for each child included in the study.
Measured: 1 Month
Recorded side effects, complications
Recorded side effects, complications
Measured: 1 Month
Acceptability of the technique : refusal to participate.
Acceptability of the technique: number of refusals to participate in the protocol during the study.
Measured: 25 Months
Acceptability of the technique: reason for refusal to participate.
Acceptability of the technique: reasons of refusals to participate in the protocol during the study.
Measured: 25 months
Acceptability of the technique: interruption of participation.
Acceptability of the technique: number of requests for interruption during the study.
Measured: 25 months
Acceptability of the technique: reason for interruption of participation
Acceptability of the technique: reasons for discontinuations for requests of interruption during the study.
Measured: 25 months
Feasibility of the technique
Feasibility of the technique: integration into the management of CVO: number of sessions not performed or interrupted and reasons, duration of sessions.
Measured: 25 months
Inclusion rate
Monthly inclusion rate in the study, characteristics of the eligible population, included and not included.
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Jun 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease (SCD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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\'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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- COLLOT SOPHIE, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619197
- Sponsor's protocol ID
- 69HCL22_0315
- Other IDs
- 2023-A01667-38
- Acronym
- REFLEXODREPANO
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Global Reflexology Proposed in the Management of Pain in Children With Sickle Cell Disease in Vaso-occlusive Crisis
- ClinicalTrials.gov ID
- NCT06619197
- Acronym / sponsor ID
- REFLEXODREPANO / 69HCL22_0315
- Conditions
- Sickle Cell Disease (SCD)
- Keywords
- Reflexology, Pain, sickle cell disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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\'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.
| Arm | Type | Receives |
|---|---|---|
| global reflexology | Other | Other: Global reflexologyThis 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global reflexologyThe 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. | Other | global reflexology |
Primary outcome
Pain score T20 with the Face Legs Activity Cry Consolability scale
Time frame: 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
Time frame: 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
11 secondary outcomes
Pain score T80 with the Visual Analog Scale
Time frame: 80 MINUTES after the start of the session
Pain score T80 with the Face Legs Activity Cry Consolability scale
Time frame: 80 minutes after the start of the session
Length of hospitalization
Time frame: 1 Month
Number of reflexology sessions
Time frame: 1 Month
Recorded side effects, complications
Time frame: 1 Month
Acceptability of the technique : refusal to participate.
Time frame: 25 Months
Acceptability of the technique: reason for refusal to participate.
Time frame: 25 months
Acceptability of the technique: interruption of participation.
Time frame: 25 months
Acceptability of the technique: reason for interruption of participation
Time frame: 25 months
Feasibility of the technique
Time frame: 25 months
Inclusion rate
Time frame: 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
COLLOT SOPHIE principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global reflexology in people with Sickle Cell Disease (SCD), run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact COLLOT Sophie (0033472115165, sophie.collot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score T20 with the Face Legs Activity Cry Consolability scale (time frame: 20 minutes after the start of the session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.