Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization (GETREADY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease in Children

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Maren Kleine-Brueggeney, Prof. Dr.; Phone Number: +493045932618; Email: maren.kleine-brueggeney@dhzc-charite.de

Study Locations

• Germany
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10553
      • Recruiting
      • DHZC, Charité Universtiätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children undergoing cardiac surgery or cardiac catheterization.

Description

Inclusion Criteria:

• All children undergoing cardiac surgery or cardiac catheterization.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Baseline; 100 children assessed in 2025
Follow up; 100 children to be assessed in 2026

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Separation Anxiety Scale	PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation	At handover from ward to anaesthesia-/ cathlab-team

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
University of Michigan Sedation Score	UMSS, 5 point score from awake (0) to unarousable (4)	At handover from ward to anaesthesia-/ cathlab-team
Modified Yale Preoperative Anxiety Scale - Short Form	mYPAS-SF; Score across 4 categories, 100 is maximum, 22.9 is minimum, higher scores represent worse measures	at handover from ward to anaesthesia or cathlab-team
Faces scale	Faces scale (pictures of different faces) for children to express how they feel	At handover from ward to anaesthesia-/ cathlab-team
VAS anxiety scale	Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety	At handover of child from ward to anaesthesia-/ cathlab team
heart rate	heart rate	At handover from ward to anaesthesia-/ cathlab team
Patient and parent reported outcome and experience measure	experience on the ward	Between admission to the ward and handover to anaesthesia/ cathlab-team
Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians	Assessment by the team of the ward and the anaesthesia-/ cathlab-team	From admission to the ward until sedation/ anaesthesia
Follow up	Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure	2 weeks after surgery / cathlab procedure

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anxiety; congenital heart disease; PROMS; PREMS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anxiety Disorders; Heart Defects, Congenital
• Other Study ID Numbers: EA2/209/24; DRKS00035813 (Registry Identifier: German Clinical Trials Register (DRKS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No