Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery

January 16, 2026 updated by: Zeynep Kızılcık Ozkan, Trakya University

Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery: A Randomized Controlled Trial

The aim of this study was to investigate the effects of foot bath application on pain level, comfort and sleep quality in the postoperative period.

H1: Foot baths have a postoperative pain-reducing effect. H2: Foot baths have a postoperative comfort-enhancing effect. H3: Foot baths have a postoperative sleep-improving effect.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The research will be conducted with the participation of surgical patients who underwent abdominal surgery between December 2025 and December 2026 in the General Surgery Department of Tekirdag University Hospital.

Using the G*Power 3.1.9.4 program, the minimum number of people to be included in the sample was found to be 88 (44:44), assuming an effect size of 0.8 at a 95% confidence level and a 95% power ratio. To avoid the risk of sample loss, it was decided to include 48 patients in each group.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Cahit Arf Boulevard
      • Edirne, Cahit Arf Boulevard, Turkey (Türkiye), 22030
        • Trakya University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • who are hospitalized in the General Surgery Clinic,
  • are on day 0 of surgery,
  • volunteer to participate in the study,
  • have no neuropsychiatric diagnosis and are not taking antipsychotic medications,
  • are over 18 years of age,
  • accept random selection,
  • and undergo abdominal surgery.
  • For the experimental group, all patients with no infectious diseases (shingles, fungal infections, eczema, warts, calluses), local infections (abscesses, etc.), open lesions/wounds, scar tissue, edema, hematomas, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorders, varicose veins, osteoporosis, osteomyelitis, hepatitis, degenerative joint diseases, neuropathy due to diabetes, toe deformities, recent fractures, dislocations, or ruptures of muscle fibers, tendons, or ligaments will be included in the sample.

Exclusion Criteria:

  • patients who underwent multiple simultaneous surgeries along with abdominal surgery,
  • those with postoperative complications such as delirium,
  • those who underwent reoperation,
  • those with a pain score >7 because it could affect sleep levels,
  • and those who received narcotic analgesics on postoperative day 0 due to pain will be excluded from the sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C)

Postoperative Preparation: The intervention will commence once the effects of anesthesia have subsided and initial mobilization (routinely 6-8 hours post-surgery) has been achieved. At approximately 9:00 PM, the patient's feet will be prepared by removing socks or adjusting anti-embolic stockings above the ankle . A visual and physical examination of the feet will be conducted to screen for contraindications such as pressure injuries, wounds, or discoloration.

Foot Bath Intervention: The foot bath procedure will be performed using a disinfected device lined with single-use, watertight bags to ensure hygiene.The water temperature will be strictly maintained at 41-42°C, verified by a non-contact infrared digital thermometer. Both feet will be immersed in the device for a duration of 20 minutes. Post-intervention, the researcher will thoroughly dry the patient's feet and replace their socks or anti-embolic stockings. Any adverse events or side effects observed, recorded.
Other: Foot bath device
On the day of surgery, patients will receive a foot bath between 9:00 PM and 10:00 PM. Any socks or clothing on both feet will be removed. The feet will be visually and manually examined to determine if they show any signs of illness (pressure ulcers, discoloration, wounds, etc.). The patient will be informed that the foot bath device is disinfected before each use and that water-tight bags will be placed around the device to prevent contact between the foot and the water to facilitate repeated use. The water temperature will be adjusted to 41-42°C using an infrared thermometer (non-contact digital thermometer). Both feet will be placed inside the foot bath device. The patient's feet will remain in the foot bath device for 20 minutes. After the foot bath, the patient's feet will be thoroughly dried with a towel, and the patient will be re-dressed in their existing socks or anti-embolic stockings. Any side effects/adverse reactions, etc., related to the foot bath will be questioned and
No Intervention: Control group Control group (Standard care (no foot bath procedure)

Patients in the control group will receive routine care. Patient Recruitment and Preoperative Phase: Patients admitted to the General Surgery department for abdominal surgery will be informed about the study on the morning of their procedure. Following the acquisition of both verbal and written informed consent, the Patient Information Form will be completed. To establish a baseline for sleep quality, the Richards-Campbell Sleep Questionnaire (RCSQ) will be administered preoperatively.

No foot bath application will be in question for the patients in the control group.

Data Collection and Conclusion: On the morning of the first postoperative day, the RCSQ, GKO (Visual Analog Scale/Global Quality Scale), and pain scores will be administered to evaluate the intervention's impact. The data collection process will conclude following these assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: postoperative period (first day)
"Numerical rating scale" A score of 0 (zero) indicates no pain, while a score of 10 (ten) indicates unbearable pain.
postoperative period (first day)
sleep quality
Time Frame: postoperative period (1st day)
"The Richards-Campbell Sleep Questionnaire" Each item is scored on a visual analog scale from 0 to 100. Scores between 0 and 25 indicate very poor sleep, while scores between 76 and 100 indicate very good sleep.
postoperative period (1st day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effect
Time Frame: during application and 12 hours of application.
Adverse effect (Yes or No)
during application and 12 hours of application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Investigators

  • Study Chair: ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof, Trakya University
  • Principal Investigator: Ayşe Nur Aktaş, Reg.Nurse, Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 29, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

While obtaining ethics committee approval, the application form included information that the data would only be used by researchers and would not be shared with third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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