Impact of Foot Reflexology on Nausea After Obesity Surgery (IRANNO)

Centre Hospitalier Departemental Vendee

Status

Not yet enrolling

Conditions

Sleeve Gastrectomy

Treatments

Other: Foot reflexology

Study type

Interventional

Funder types

Other

Identifiers

NCT07313293

CHD25_0097

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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