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NCT Number: NCT07126223

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital

Istanbul, 34098, Turkey (Türkiye)

Location contact

Cansu Mert, RN, MSc.

CONTACT

[email protected]

+905365954172

Cansu Mert, RN, MSc.

SUB_INVESTIGATOR

Emre Kuğu, RN, MSc.

SUB_INVESTIGATOR

Yasemin Özhanlı, RN, PhD.

PRINCIPAL_INVESTIGATOR

Özkan Karadede, RN, MSc.

CONTACT

[email protected]

+905067705766

Özkan Karadede, RN, MSc.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)

    Time frame: 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.

  2. Postoperative pain intensity at 1 hour after the intervention

    Time frame: 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.

  3. Postoperative pain intensity at 2 hours after the intervention

    Time frame: 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.

  4. Time to first postoperative gas release

    Time frame: 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.

Secondary outcomes

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

    Time frame: 0-24 hours after surgery

    Total amount of analgesics (e.g., paracetamol, NSAIDs, opioids) administered and/or requested will be recorded from medical records.

  2. Age (years)

    Time frame: Baseline (upon study entry)

    Participant age will be recorded from medical records in years.

  3. Sex

    Time frame: Baseline (upon study entry)

    Participant sex (male/female) will be recorded.

  4. Body Mass Index (BMI)

    Time frame: Baseline (upon study entry)

    BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m².

  5. ASA Physical Status Classification

    Time frame: Baseline (upon study entry)

    ASA physical status classification will be noted from the preoperative anesthesia evaluation

  6. Type of anesthesia

    Time frame: Baseline (upon study entry)

    Type of anesthesia administered (general/regional) will be recorded.

  7. Surgical duration

    Time frame: From skin incision to skin closure

    Duration of the surgical procedure (in minutes) will be recorded.

  8. Comorbidities

    Time frame: Baseline (upon study entry)

    Pre-existing comorbid conditions will be documented using structured data form.

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu Mert, RN, MSc.

CONTACT

[email protected]

+905365954172

Yasemin Özhanlı, RN, PhD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cansu Mert

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

The Effect of Hot Water Foot Bath on Pain and Gas Release After Laparoscopic Cholecystectomy: A Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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