Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

Официальное название

Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures

Обзор

Children undergoing cardiac surgery or cardiac catheterization often experience significant stress and anxiety during the preoperative period. A prospective, observational assessment of the preoperative/ preinterventional phase in 100 children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité demonstrated a considerable proportion of pediatric patients present with clinically relevant levels of anxiety before these procedures. Several aspects of the preoperative workflow were identified as potentially modifiable to improve the preparation of children and their families. Based on these findings, changes in clinical practice were implemented. These measures aim to create a more supportive environment for children undergoing cardiac interventions or surgery. The investigators now aim to re-evaluate the current preoperative preparation process for children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité and to assess its impact on preoperative stress and anxiety levels. Another 100 children will be enrolled for this follow-up assessment (100 children assessed at baseline in 2025, 100 children to be assessed in 2026, starting end of January 2026). Anxiety and stress and other patient reported outcome and experience measures as well as procedural and clinical data are assessed using validated questionnaires and CRFs prior to the procedure. The perspectives of parents or legal guardians and members of the clinical care team will also be considered to provide a comprehensive view of the preoperative experience.

Первичные конечные точки

• Parental Separation Anxiety Scale [Срок оценки: At handover from ward to anaesthesia-/ cathlab-team]

Вторичные конечные точки (8)

• University of Michigan Sedation Score [Срок оценки: At handover from ward to anaesthesia-/ cathlab-team]
• Modified Yale Preoperative Anxiety Scale - Short Form [Срок оценки: at handover from ward to anaesthesia or cathlab-team]
• Faces scale [Срок оценки: At handover from ward to anaesthesia-/ cathlab-team]
• VAS anxiety scale [Срок оценки: At handover of child from ward to anaesthesia-/ cathlab team]
• heart rate [Срок оценки: At handover from ward to anaesthesia-/ cathlab team]
• Patient and parent reported outcome and experience measure [Срок оценки: Between admission to the ward and handover to anaesthesia/ cathlab-team]
• Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians [Срок оценки: From admission to the ward until sedation/ anaesthesia]
• Follow up [Срок оценки: 2 weeks after surgery / cathlab procedure]

Критерии участия

Критерии включения

• All children undergoing cardiac surgery or cardiac catheterization.

Критерии исключения

• Children who are already intubated or tracheotomized and sedated.
• Children and families who, due to insufficient language skills and lack of interpreters, cannot be informed about the study and cannot consent, and/or cannot complete the questionnaires.
• Emergency interventions.
• Death of the child.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• DHZC, Charité Universtiätsmedizin Berlin — Berlin

Идентификаторы

NCT: NCT07414251 · EA2/209/24 · DRKS00035813

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗