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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
62
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.
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye)
Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Time frame: 3 hours after transfer to the ward
Postoperative pain intensity at 1 hour after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Time frame: 1 hour after the intervention
Postoperative pain intensity at 2 hours after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Time frame: 2 hours after the intervention
Time to first postoperative gas release
The time (in hours) from the end of surgery to the first postoperative gas release will be recorded. Patients or caregivers will use a monitoring form to document the exact time of gas passage, which will be confirmed by the research team during routine postoperative follow-up.
Time frame: Up to 72 hours postoperatively
Total dose of analgesic medication used within the first 24 hours postoperatively
Total amount of analgesics (e.g., paracetamol, NSAIDs, opioids) administered and/or requested will be recorded from medical records.
Time frame: 0-24 hours after surgery
Age (years)
Participant age will be recorded from medical records in years.
Time frame: Baseline (upon study entry)
Sex
Participant sex (male/female) will be recorded.
Time frame: Baseline (upon study entry)
Body Mass Index (BMI)
BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m².
Time frame: Baseline (upon study entry)
ASA Physical Status Classification
ASA physical status classification will be noted from the preoperative anesthesia evaluation
Time frame: Baseline (upon study entry)
Type of anesthesia
Type of anesthesia administered (general/regional) will be recorded.
Time frame: Baseline (upon study entry)
Surgical duration
Duration of the surgical procedure (in minutes) will be recorded.
Time frame: From skin incision to skin closure
Comorbidities
Pre-existing comorbid conditions will be documented using structured data form.
Time frame: Baseline (upon study entry)
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