NCT07313293 Impact of Foot Reflexology on Nausea After Obesity Surgery
| NCT ID | NCT07313293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Departemental Vendee |
| Condition | Sleeve Gastrectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2028-04-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-01 with a primary completion date of 2028-04-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Emeric ABET
PRINCIPAL INVESTIGATOR
Centre Hospitalier Departemental Vendee
Frequently Asked Questions
Who can join the NCT07313293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleeve Gastrectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313293 currently recruiting?
Yes, NCT07313293 is actively recruiting participants. Contact the research team at chloe.moreau@ght85.fr for enrollment information.
Where is the NCT07313293 trial being conducted?
This trial is being conducted at La Roche-sur-Yon, France.
Who is sponsoring the NCT07313293 clinical trial?
NCT07313293 is sponsored by Centre Hospitalier Departemental Vendee. The principal investigator is Emeric ABET at Centre Hospitalier Departemental Vendee. The trial plans to enroll 60 participants.