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Набор скоро начнётся NCT07366567

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

Без фазы С лечением Pain, Postoperative Sleep

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Foot bath device.
Кому может быть актуально
Состояния в реестре: Pain, Postoperative, Sleep. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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

Первичные конечные точки

  • Pain level [Срок оценки: postoperative period (first day)]
  • sleep quality [Срок оценки: postoperative period (1st day)]
Вторичные конечные точки (1)
  • Adverse effect [Срок оценки: during application and 12 hours of application.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

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

Идентификаторы

NCT: NCT07366567 · 2025/284

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗