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Набор скоро начнётся NCT06752980

The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: A Randomized Controlled Study

Без фазы С лечением Cardiovascular Surgical Procedures

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: Eye mask, Earplugs, Eye Mask and Earplugs.
Кому может быть актуально
Состояния в реестре: Cardiovascular Surgical Procedures. Базовые параметры: 18 лет — 79 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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Обзор

Coronary artery bypass grafting is the most commonly performed surgical procedure among cardiovascular diseases. Nursing care for patients undergoing cardiac surgery involves a process that includes preoperative preparation and subsequent close monitoring of neurological, cardiac, respiratory, vascular status, kidney function, and pain. Sleep disturbances are observed after cardiac surgery. Sleep plays a critical role in the body's maintenance, repair, and renewal processes. Improved sleep can reduce patient agitation and decrease the risk of delirium. The presence of delirium leads to increased care requirements and prolonged hospital stays, which in turn raises hospital costs. Enhancing sleep quality and preventing delirium after surgery have positive effects on clinical patient outcomes. This study is designed to determine the effects of using eye masks and/or earplugs on sleep quality and delirium in patients undergoing coronary artery bypass grafting during nighttime sleep. This research is a randomized controlled clinical trial.

Вмешательства

  • Другое Eye mask
    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.
  • Другое Earplugs
    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.
  • Другое Eye Mask and Earplugs
    The three experimental groups (eye patch group, earplug group, eye patch and earplug group applied together) will be given a separate intervention during their night sleep on the 1st, 2nd and 3rd postoperative day. Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th postoperative days.

Первичные конечные точки

  • Richards-Campbell Sleep Scale [Срок оценки: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.]
  • Nursing Delirium Screening Scale- Nu-DESC [Срок оценки: Repeated monitoring will be performed using RCUÖ and Nu-DESC on the 2nd, 3rd and 4th days after surgery.]

Критерии участия

Критерии включения

-Patients who voluntarily agree to participate in the study

  • Those who have undergone coronary artery bypass graft surgery
  • Those between the ages of 18-79
  • Those who are cooperative and oriented
  • Those who are literate
  • Those who speak Turkish
  • Those whose initial delirium scale score (Nu-DECS) is less than 2
  • Those whose Glasgow coma scale score is >13 will be included in the study.

Критерии исключения

  • • Patients diagnosed with sleep disorders,
  • Those using sleeping pills,
  • Those who have a habit of using an eye patch while sleeping,
  • Those who were not transferred to the clinic on the first day after surgery and whose treatment continues in the intensive care unit,
  • Those who develop complications and/or need to be re-operated,
  • Those who need treatment other than routine treatment,
  • Patients with hearing or vision problems will be excluded.

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
Тройное слепое
Основная цель
Организация здравоохранения

Центры проведения

Turkey (Türkiye) · 1 центр
  • Necmettin Erbakan Universıty — Selçuklu

Публикации

  • Kilic G, Kav S. Effect of using eye masks and earplugs in preventing delirium in intensive care patients: A single-blinded, randomized, controlled trial. Nurs Crit Care. 2023 Sep;28(5):698-708. doi: 10.1111/nicc.12901. Epub 2023 May 3. PMID 37138379

Идентификаторы

NCT: NCT06752980 · NecmettinEU-SBF-ZB-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗