About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Undergoing elective laparoscopic cholecystectomy
Received the same preoperative gastrointestinal preparation protocol
Received the same postoperative analgesia protocol
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Hot water foot bath
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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 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.
Secondary outcomes
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.
Age (years)
Participant age will be recorded from medical records in years.
Sex
Participant sex (male/female) will be recorded.
Body Mass Index (BMI)
BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m².
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cansu Mert
Lead sponsor
Fenerbahce University
Sponsor institution
Istanbul University - Cerrahpasa
Collaborator
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