Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

NCT07414251 | Recruiting

• 2 other identifiers: EA2/209/24DRKS00035813
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease in Children

Keywords

anxiety; congenital heart disease; PROMS; PREMS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• heart rate

  At handover from ward to anaesthesia-/ cathlab team

Study Arms (2)

Baseline

100 children assessed in 2025

Follow up

100 children to be assessed in 2026

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing cardiac surgery or cardiac catheterization.

You may qualify if:

• All children undergoing cardiac surgery or cardiac catheterization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

DHZC, Charité Universtiätsmedizin Berlin

Berlin, State of Berlin, 10553, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Mental Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Maren Kleine-Brueggeney, Prof. Dr.

CONTACT

+493045932618; maren.kleine-brueggeney@dhzc-charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 17, 2026
• Study Start: January 9, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 15, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1)