Sleeve GastrectomyIRANNONCT07313293
Impact of Foot Reflexology on Nausea After Obesity Surgery
A study testing Foot reflexology in people with Sleeve Gastrectomy, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Obesity is a major public health issue. The Obépi epidemiological survey, the results of which were published in 2020, shows a steady increase in obesity among the French population. Currently, more than 23 million French people are overweight or obese, and more than 8 million French people are obese. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleeve Gastrectomy
- What is being tested?
- Foot reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 3 Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Patient scheduled to undergo sleeve gastrectomy
- Patient capable of understanding the protocol and having given their informed verbal consent to participate in the study
- Patient affiliated with the social security system or entitled to benefits
Who cannot join
- Patients receiving long-term morphine and opioid treatment
- Patients with phlebitis, a wound under the foot, or recent foot trauma (cast immobilisation, splint, etc.)
- Patients under guardianship, curatorship, or deprived of their liberty
- Patients who are pregnant, breastfeeding, or refusing contraception
- Patients participating in another clinical research protocol that has an impact on the objective of the study
- Patients under an activated future protection mandate
- Patients under family authorisation
- Patients under judicial protection
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
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
Emeric ABET
About this study
Obesity is a major public health issue. The Obépi epidemiological survey, the results of which were published in 2020, shows a steady increase in obesity among the French population.
Currently, more than 23 million French people are overweight or obese, and more than 8 million French people are obese. The most effective treatment currently available is surgery. These procedures are governed by specific recommendations. Between 50,000 and 60,000 procedures are performed in France each year. Three procedures are authorised: gastric banding, sleeve gastrectomy and gastric bypass.
Read more
Hallyday \& al report 65% of patients experiencing nausea/vomiting after bariatric surgery. In 2019, Suh \& al showed that nausea and vomiting were more common after sleeve gastrectomy and that they were responsible for an increase in the length of hospitalisation. These episodes of nausea and vomiting occur within 48 hours after sleeve gastrectomy and can cause difficulties in resuming eating. One of the factors contributing to the occurrence of nausea and vomiting was the use of opioids.
The benefits of foot reflexology were reported in 2023 by Dr Carrazé in rectal surgery. His doctoral thesis in medicine showed that foot reflexology sessions on days 1, 2 and 3 following rectal surgery reduced post-operative ileus and post-operative pain. The reduction in post-operative ileus led to a decrease in episodes of nausea and vomiting.
In 2021, Murat-Ringot \& al demonstrated the beneficial effect of foot reflexology on nausea and vomiting during chemotherapy sessions, in addition to the anti-emetic treatments used for prevention. Anderson \& al. in 2021 also demonstrated a beneficial effect on pain in cancer patients, with no effect on nausea.
The principle of foot reflexology is based on the fact that each organ, gland or part of the body corresponds to a reflex zone on the foot, hand, ears or face. Stimulation of the reflex zones is thought to activate the autonomic nervous system. Currently, there is very little scientific evidence on how this practice works and what its effects are. Despite various scientific publications on the results of foot reflexology, scientific evidence of its effectiveness remains weak. Only one prospective randomised trial has been found in the literature (Dalal \& al.) on the quality of life of patients with epilepsy.
Despite the lack of high-quality studies, it appears that foot reflexology could benefit patients by reducing nausea and vomiting. To date, no studies have evaluated its effectiveness in the post-operative period, particularly after bariatric surgery.
The aim of our randomised trial is to evaluate the impact of foot reflexology on nausea and vomiting after sleeve gastrectomy.
- Conditions
- Sleeve Gastrectomy
- Being tested
- Foot reflexology
- Keywords
- foot reflexology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexologyOther
Foot reflexology sessions to:
- Prepare the body and mind for surgery
- Promote physical and nervous relaxation
- Relieve post-operative nausea and vomiting
| Study group | Role | What they receive |
|---|---|---|
| Conventional care alone | No intervention | Not described |
| Conventional care + foot reflexology | Experimental | Not described Receives: Other: Foot reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing significant nausea and/or vomiting (with a score ≥ 3 on a numerical scale of 0 to 10) within 24 hours post-operatively
A score of ≥ 3 corresponds to the introduction of treatment.
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Apr 2026
- Primary completion2 Apr 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleeve GastrectomyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeric ABET, Principal investigator, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313293
- Sponsor's protocol ID
- CHD25_0097
- Acronym
- IRANNO
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dalal K, Devarajan E, Pandey RM, Subbiah V, Tripathi M. Role of reflexology and antiepileptic drugs in managing intractable epilepsy--a randomized controlled trial. Forsch Komplementmed. 2013;20(2):104-11. doi: 10.1159/000350047. Epub 2013 Apr 15.
PubMed 23636029Anderson KD, Downey M. Foot Reflexology: An Intervention for Pain and Nausea Among Inpatients With Cancer. Clin J Oncol Nurs. 2021 Oct 1;25(5):539-545. doi: 10.1188/21.CJON.539-545.
PubMed 34533507Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.
PubMed 34738909Suh S, Helm M, Kindel TL, Goldblatt MI, Gould JC, Higgins RM. The impact of nausea on post-operative outcomes in bariatric surgery patients. Surg Endosc. 2020 Jul;34(7):3085-3091. doi: 10.1007/s00464-019-07058-5. Epub 2019 Aug 6.
PubMed 31388805Halliday TA, Sundqvist J, Hultin M, Wallden J. Post-operative nausea and vomiting in bariatric surgery patients: an observational study. Acta Anaesthesiol Scand. 2017 May;61(5):471-479. doi: 10.1111/aas.12884.
PubMed 28374473
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Foot Reflexology on Nausea After Obesity Surgery
- ClinicalTrials.gov ID
- NCT07313293
- Acronym / sponsor ID
- IRANNO / CHD25_0097
- Conditions
- Sleeve Gastrectomy
- Keywords
- foot reflexology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 2 Apr 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 31 Dec 2025 (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.
Obesity is a major public health issue. The Obépi epidemiological survey, the results of which were published in 2020, shows a steady increase in obesity among the French population.
Currently, more than 23 million French people are overweight or obese, and more than 8 million French people are obese. The most effective treatment currently available is surgery. These procedures are governed by specific recommendations. Between 50,000 and 60,000 procedures are performed in France each year. Three procedures are authorised: gastric banding, sleeve gastrectomy and gastric bypass.
Hallyday \& al report 65% of patients experiencing nausea/vomiting after bariatric surgery. In 2019, Suh \& al showed that nausea and vomiting were more common after sleeve gastrectomy and that they were responsible for an increase in the length of hospitalisation. These episodes of nausea and vomiting occur within 48 hours after sleeve gastrectomy and can cause difficulties in resuming eating. One of the factors contributing to the occurrence of nausea and vomiting was the use of opioids.
The benefits of foot reflexology were reported in 2023 by Dr Carrazé in rectal surgery. His doctoral thesis in medicine showed that foot reflexology sessions on days 1, 2 and 3 following rectal surgery reduced post-operative ileus and post-operative pain. The reduction in post-operative ileus led to a decrease in episodes of nausea and vomiting.
In 2021, Murat-Ringot \& al demonstrated the beneficial effect of foot reflexology on nausea and vomiting during chemotherapy sessions, in addition to the anti-emetic treatments used for prevention. Anderson \& al. in 2021 also demonstrated a beneficial effect on pain in cancer patients, with no effect on nausea.
The principle of foot reflexology is based on the fact that each organ, gland or part of the body corresponds to a reflex zone on the foot, hand, ears or face. Stimulation of the reflex zones is thought to activate the autonomic nervous system. Currently, there is very little scientific evidence on how this practice works and what its effects are. Despite various scientific publications on the results of foot reflexology, scientific evidence of its effectiveness remains weak. Only one prospective randomised trial has been found in the literature (Dalal \& al.) on the quality of life of patients with epilepsy.
Despite the lack of high-quality studies, it appears that foot reflexology could benefit patients by reducing nausea and vomiting. To date, no studies have evaluated its effectiveness in the post-operative period, particularly after bariatric surgery.
The aim of our randomised trial is to evaluate the impact of foot reflexology on nausea and vomiting after sleeve gastrectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care alone | No intervention | – |
| Conventional care + foot reflexology | Experimental | Other: Foot reflexology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Patient scheduled to undergo sleeve gastrectomy
- Patient capable of understanding the protocol and having given their informed verbal consent to participate in the study
- Patient affiliated with the social security system or entitled to benefits
Key exclusion criteria (8 listed)
- Patients receiving long-term morphine and opioid treatment
- Patients with phlebitis, a wound under the foot, or recent foot trauma (cast immobilisation, splint, etc.)
- Patients under guardianship, curatorship, or deprived of their liberty
- Patients who are pregnant, breastfeeding, or refusing contraception
- Patients participating in another clinical research protocol that has an impact on the objective of the study
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 |
|---|---|---|
| Foot reflexologyFoot reflexology sessions to: * Prepare the body and mind for surgery * Promote physical and nervous relaxation * Relieve post-operative nausea and vomiting | Other | Conventional care + foot reflexology |
Primary outcome
Number of patients experiencing significant nausea and/or vomiting (with a score ≥ 3 on a numerical scale of 0 to 10) within 24 hours post-operatively
Time frame: 24 hours post-operatively
A score of ≥ 3 corresponds to the introduction of treatment.
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 2 Apr 2026.
- Background: PubMed 23636029Dalal K, Devarajan E, Pandey RM, Subbiah V, Tripathi M. Role of reflexology and antiepileptic drugs in managing intractable epilepsy--a randomized controlled trial. Forsch Komplementmed. 2013;20(2):104-11. doi: 10.1159/000350047. Epub 2013 Apr 15.
- Background: PubMed 34533507Anderson KD, Downey M. Foot Reflexology: An Intervention for Pain and Nausea Among Inpatients With Cancer. Clin J Oncol Nurs. 2021 Oct 1;25(5):539-545. doi: 10.1188/21.CJON.539-545.
- Background: PubMed 34738909Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.
- Background: PubMed 31388805Suh S, Helm M, Kindel TL, Goldblatt MI, Gould JC, Higgins RM. The impact of nausea on post-operative outcomes in bariatric surgery patients. Surg Endosc. 2020 Jul;34(7):3085-3091. doi: 10.1007/s00464-019-07058-5. Epub 2019 Aug 6.
- Background: PubMed 28374473Halliday TA, Sundqvist J, Hultin M, Wallden J. Post-operative nausea and vomiting in bariatric surgery patients: an observational study. Acta Anaesthesiol Scand. 2017 May;61(5):471-479. doi: 10.1111/aas.12884.
- Individual participant dataSharing planned: No
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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.
Emeric ABET principal investigator
Centre Hospitalier Departemental Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot reflexology in people with Sleeve Gastrectomy, run by Centre Hospitalier Departemental Vendee 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 4 inclusion and 8 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 2 Apr 2026. 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 Chloé MOREAU (251446327 ext. +33, chloe.moreau@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing significant nausea and/or vomiting (with a score ≥ 3 on a numerical scale of 0 to 10) within 24 hours post-operatively (time frame: 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07313293, which also lists 5 linked publications.
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 2 Apr 2026.