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

NCT07126223 | Not Yet Recruiting

• 1 other identifier: 103.2024fbu
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

foot bath; gas release; pain management; complementary therapy; nursing; cholesistectomy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 72 hours postoperatively

Secondary Outcomes (8)

• Total dose of analgesic medication used within the first 24 hours postoperatively

  0-24 hours after surgery

• Age (years)

  Baseline (upon study entry)

• Sex

  Baseline (upon study entry)

• Body Mass Index (BMI)

  Baseline (upon study entry)

• ASA Physical Status Classification

  Baseline (upon study entry)

Study Arms (2)

Hot water foot bath group

EXPERIMENTAL

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.

Behavioral: Hot water foot bath

Standard postoperative care group

NO INTERVENTION

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.

Interventions

Hot water foot bath BEHAVIORAL

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.

Hot water foot bath group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cansu Mert: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Cansu Mert, RN, MSc.

CONTACT

+905365954172; ozkan.karadede@iuc.edu.tr

Yasemin Özhanlı, RN, PhD.

CONTACT

yaseminozhanli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor responsible for recording postoperative pain levels and time to first flatus will be blinded to group allocation in order to reduce measurement bias. Participants and care providers cannot be blinded due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned to one of two parallel groups: the intervention group receiving a hot foot bath and the control group receiving standard postoperative care. Both groups will be monitored concurrently without crossover throughout the study.

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 17, 2025
• Study Start: December 20, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)