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临床试验/NCT07414251
NCT07414251招募中不适用

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Parental Separation Anxiety Scale

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All children undergoing cardiac surgery or cardiac catheterization.

排除标准

  • 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.

研究组 & 干预措施

Baseline

100 children assessed in 2025

Follow up

100 children to be assessed in 2026

结局指标

主要结局

Parental Separation Anxiety Scale

时间窗: At handover from ward to anaesthesia-/ cathlab-team

PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Maren Kleine-Brüggeney

Professor of Anesthesiology

Charite University, Berlin, Germany

研究点 (1)

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