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Not yet recruiting NCT07366567

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

No phase Interventional Pain, Postoperative Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Foot bath device.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Pain level [Time frame: postoperative period (first day)]
  • sleep quality [Time frame: postoperative period (1st day)]
Secondary outcome measures (1)
  • Adverse effect [Time frame: during application and 12 hours of application.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Trakya University Hospital — Edirne

Identifiers

NCT: NCT07366567 · 2025/284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗