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

Cansu Mert

Status: Not yet enrolling

Conditions: Postoperative Pain; Postoperative Recovery; Nursing Interventions; Laparoscopic Cholecystectomy; Gastrointestinal Motility

Treatments: Behavioral: Hot water foot bath

Study type: Interventional

Funder types: Other

Identifiers

NCT07126223

103.2024fbu

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Hot water foot bath group

Experimental group

Description:

Participants in this group will receive a 20-minute hot foot bath using a device with fixed temperature control (41°C), anti-slip base, timer, and vibration massage features. The intervention will be conducted 3 hours after postoperative transfer to the ward, once the patient is clinically stable. The room temperature will be maintained between 22°C and 25°C throughout the intervention. Participants will sit in a chair and immerse their feet in 41°C water for 20 minutes. Afterward, their feet will be wrapped in a towel for 10 minutes to retain heat. Pain levels (NRS) will be assessed immediately before the intervention, and again at 1 and 2 hours post-intervention (corresponding to 4h30 and 5h30 post-surgery). Time to first flatus will also be tracked using a monitoring form filled by patients or caregivers.

Treatment:

Behavioral: Hot water foot bath

Standard postoperative care group

No Intervention group

Description:

Participants in this group will receive standard postoperative care without any foot bath intervention. Pain levels (NRS) will be evaluated at 3h30, 4h30, and 5h30 after surgery. Room temperature will be maintained between 22°C and 25°C. First gas passage time will be tracked using a monitoring form completed by the patient or caregiver.