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Not yet recruitingNCT07366567Updated Jan 26, 2026

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

An interventional study of Foot bath device in Pain, Postoperative and Sleep, sponsored by Trakya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by Trakya University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain, Postoperative
  • Sleep

Keywords

  • pain
  • foot bath
  • sleep quality
  • comfort
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 96 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherFoot 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

06

What researchers measure

Primary outcomes

  1. Pain level

    "Numerical rating scale" A score of 0 (zero) indicates no pain, while a score of 10 (ten) indicates unbearable pain.

    Time frame: postoperative period (first day)

  2. sleep quality

    "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.

    Time frame: postoperative period (1st day)

Secondary outcomes

  1. Adverse effect

    Adverse effect (Yes or No)

    Time frame: during application and 12 hours of application.

07

Study locations

1 site
  • Trakya University Hospital
    Edirne, Cahit Arf Boulevard 22030, Turkey (Türkiye)
08

References and documents

Study documents

  • Study protocol · Aug 25, 2025
  • Statistical analysis plan · Aug 25, 2025
  • Informed consent form · Aug 25, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07366567
Lead sponsor
Trakya University
Responsible party
Zeynep Kızılcık Ozkan (Associate professor, Trakya University) — Principal investigator
First posted
Jan 26, 2026
Start date
Dec 29, 2025 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jan 26, 2026

Study contacts

ZEYNEP KIZILCIK ÖZKAN, Assco.Prof
Contact
zeynepozkan@trakya.edu.tr
05056010101
Ayşe Nur Aktaş, Reg. Nurse
Contact
aysenuraktas24@gmail.com
ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof
study chair · Trakya University
Ayşe Nur Aktaş, Reg.Nurse
principal investigator · Trakya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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