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临床试验/NCT07313293
NCT07313293尚未招募不适用

Impact of Foot Reflexology on Nausea After Obesity Surgery

Centre Hospitalier Departemental Vendee1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Conventional care alone

No Intervention

Conventional care + foot reflexology

Experimental

干预措施: Foot reflexology (Other)

结局指标

主要结局

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

时间窗: 24 hours post-operatively

A score of ≥ 3 corresponds to the introduction of treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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