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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCansu Mert

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Hot water foot bath groupExperimental treatment 1 intervention
Group B: Standard postoperative care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

Age (years)

Participant age will be recorded from medical records in years.

Time frame
Baseline (upon study entry)
3

Sex

Participant sex (male/female) will be recorded.

Time frame
Baseline (upon study entry)
4

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)

Other outcomes

Sponsors and contacts

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Cansu Mert

Lead sponsor

Fenerbahce University

Sponsor institution

Istanbul University - Cerrahpasa

Collaborator

This trial is not recruiting at the moment. You can still explore other options: