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

NCT07126223 · tracked via the Priya Life Science Turkey tracker
Sponsor
Cansu Mert
Phase
Not applicable
Started
2025-12-20
Last updated
2025-12-05

Condition(s) studied

Laparoscopic CholecystectomyPostoperative PainGastrointestinal MotilityPostoperative RecoveryNursing Interventions

Investigational drug(s) / intervention(s)

Hot water foot bath

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline) — 3 hours after transfer to the ward
    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 — 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 — 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 — Up to 72 hours postoperatively
    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.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07126223 on ClinicalTrials.gov ↗ ← All trials in Turkey