Hot Water Foot Bath for Pain and Gas Relief After Laparoscopic Cholecystectomy

Официальное название

The Effect of Hot Water Foot Bath on Pain and Gas Release After Laparoscopic Cholecystectomy: A Randomised Controlled Trial

Обзор

This study investigates the effects of a hot foot bath on postoperative pain and time to first gas release in patients undergoing laparoscopic cholecystectomy. The intervention is a non-pharmacological supportive method applied during the early postoperative period. Participants will be randomly assigned to either intervention or control groups. No FDA-regulated drug or device is involved.

Подробное описание

This randomised controlled clinical trial aims to evaluate the effects of hot foot bath therapy on postoperative pain and time to first flatus in patients undergoing laparoscopic cholecystectomy. The hot water foot bath is a non-pharmacological, supportive intervention to be administered at 3 hours postoperatively after patients have regained consciousness and are clinically stable.

Participants will be randomly divided into two groups: the intervention group will receive a 20-minute foot bath at a water temperature of 41°C, while the control group will receive standard postoperative care without a foot bath. The primary outcomes include pain level assessed using the Numerical Rating Scale (NRS) and time to first flatus recorded in hours postoperatively.

In addition to these primary outcomes, the study will also collect data through a two-part questionnaire. The first part will include questions regarding the sociodemographic and medical history of the patients, such as age, gender, marital status, education level, income level, presence of chronic diseases, previous surgical history, preoperative bowel movement frequency and duration of surgery. The second part focuses on indicators of postoperative recovery, including time to surgery, time to postoperative ward arrival, time to first oral intake, time to first mobilisation, total mobilisation time in the first 8 hours, time to first gas passage and type of analgesic administered.

This study does not involve any drug or device regulated by the U.S. Food and Drug Administration (FDA). Ethical approval was obtained from the Fenerbahçe University Non-Interventional Research Ethics Committee. Institutional permission was also granted in writing by Istanbul University-Cerrahpaşa Faculty of Medicine Hospital, where the clinical study will be conducted. No funding was received from Fenerbahçe University or any other organization.

Вмешательства

• Поведенческое Hot water foot bath
  A 20-minute hot foot bath therapy using a specially designed foot spa device (41°C) applied in the early postoperative period. Follow-up includes pain evaluation via Numeric Rating Scale (NRS) and monitoring of first flatus time.

Первичные конечные точки

• Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline) [Срок оценки: 3 hours after transfer to the ward]
• Postoperative pain intensity at 1 hour after the intervention [Срок оценки: 1 hour after the intervention]
• Postoperative pain intensity at 2 hours after the intervention [Срок оценки: 2 hours after the intervention]
• Time to first postoperative gas release [Срок оценки: Up to 72 hours postoperatively]

Вторичные конечные точки (8)

• Total dose of analgesic medication used within the first 24 hours postoperatively [Срок оценки: 0-24 hours after surgery]
• Age (years) [Срок оценки: Baseline (upon study entry)]
• Sex [Срок оценки: Baseline (upon study entry)]
• Body Mass Index (BMI) [Срок оценки: Baseline (upon study entry)]
• ASA Physical Status Classification [Срок оценки: Baseline (upon study entry)]
• Type of anesthesia [Срок оценки: Baseline (upon study entry)]
• Surgical duration [Срок оценки: From skin incision to skin closure]
• Comorbidities [Срок оценки: Baseline (upon study entry)]

Критерии участия

Критерии включения

• Age 18 years or older
• Undergoing elective laparoscopic cholecystectomy
• Received the same preoperative gastrointestinal preparation protocol
• Received the same postoperative analgesia protocol
• Numeric Rating Scale (NRS) pain score of 3 or higher at the 3rd postoperative hour
• Voluntarily agreed to participate and signed the informed consent form
• Classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA)

Критерии исключения

• Undergoing emergency cholecystectomy or open surgery (laparotomy)
• Presence of open wounds, infections, circulatory disorders, or lesions in the feet (hot foot bath area)
• Use of patient-controlled analgesia (PCA) in the early postoperative period
• Any condition that impairs verbal communication
• History of inflammatory bowel disease (due to potential influence on bowel motility)
• Use of medications or probiotic agents affecting bowel motility in the pre- or postoperative period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital — Istanbul

Идентификаторы

NCT: NCT07126223 · 103.2024fbu

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗