Меню
Идёт набор NCT06794697

Evaluation of Preoperative Anxiety Level Based on the Day of Admission for Cardiac Surgery

Наблюдательное Cardiac Surgery

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: Questionnaire including APAIS scale.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Prospective, observational, non-randomized study that evaluates the impact of the admission day (J-1 vs J-0) on preoperative anxiety in cardiac surgery patients.

Подробное описание

The goal of this study is to determine whether the admission day (J-1 or J-0) has a significant effect on preoperative anxiety using the APAIS (Amsterdam Preoperative Anxiety and Information) scale and to identify modifiable factors to improve patient care.

This study includes 400 patients divided into two groups : 200 patients admitted the day before their surgery (J-1) and 200 patients admitted on the day of surgery (J-0).

Patients admitted for cardiac surgery at the University Hospital of Rennes will be invited to participate after verification of the inclusion criteria. A nurse or surgeon will explain the objectives and procedures of the study and provide the patient with an information and non-opposition letter. If the patient agrees, they will be included in the study, and the non-opposition form will be recorded in their medical file.

Patients will complete the questionnaire in two stages : upon admission and just before leaving for the operating room. The estimated time to complete the questionnaire is approximately 15 minutes, with 10 minutes for the first part and 5 minutes for the second part.

Вмешательства

  • Другое Questionnaire including APAIS scale
    Patients will complete a questionnaire in two stages : upon admission and just before leaving for the operating room

Первичные конечные точки

  • Comparison of the level of anxiety before leaving for the operating room between patients arriving the day before the operation and those arriving on the day of the operation. [Срок оценки: Day of scale completion]
Вторичные конечные точки (8)
  • Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups [Срок оценки: Day of scale completion]
  • Comparison of of the level of anxiety at admission and before leaving for the operating room between the 2 groups [Срок оценки: Day of scale completion]
  • Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters [Срок оценки: Day of scale completion]
  • Comparison of the level of preoperative anxiety before going to the operating room according to patient comfort parameters [Срок оценки: Day of scale completion]
  • Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure [Срок оценки: Day of scale completion]
  • Comparison of preoperative anxiety according to patient's understanding of the surgery and the type of surgical procedure [Срок оценки: Day of scale completion]
  • Comparison of preoperative anxiety according to the surgical schedule [Срок оценки: Day of scale completion]
  • Comparison of preoperative anxiety according to the surgical schedule [Срок оценки: Day of scale completion]

Критерии участия

Критерии включения

  • Aged over 18 years old
  • Scheduled for cardiac surgery
  • Have received written and oral information about the protocol
  • Admitted to the cardiac and thoracic surgery units
  • Not opposed to participating in the research.

Критерии исключения

  • Patient undergoing emergency cardiac surgery with no time for reflection
  • Legal adults under legal protection (guardianship, curators, or legal protection)
  • Pregnant or breastfeeding women, minors, individuals unable to express consent
  • Patient on long-term anxiolytic treatment
  • Patient with psychiatric disorders, cognitive impairments, or central neurological disorders.
  • Patient already participating in an ongoing study in the department of Thoracic and Cardiovascular Surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Universitaire de Rennes — Rennes

Идентификаторы

NCT: NCT06794697 · 35RC23_3034_ADMITY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗