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NCT Number: NCT07414251

Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DHZC, Charité Universtiätsmedizin Berlin

Berlin, State of Berlin, 10553, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Parental Separation Anxiety Scale

    Time frame: 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

Secondary outcomes

  1. University of Michigan Sedation Score

    Time frame: At handover from ward to anaesthesia-/ cathlab-team

    UMSS, 5 point score from awake (0) to unarousable (4)

  2. Modified Yale Preoperative Anxiety Scale - Short Form

    Time frame: at handover from ward to anaesthesia or cathlab-team

    mYPAS-SF; Score across 4 categories, 100 is maximum, 22.9 is minimum, higher scores represent worse measures

  3. Faces scale

    Time frame: At handover from ward to anaesthesia-/ cathlab-team

    Faces scale (pictures of different faces) for children to express how they feel

  4. VAS anxiety scale

    Time frame: At handover of child from ward to anaesthesia-/ cathlab team

    Visual analog scale for children to assess how anxious they feel (0-10), higher scores represent more anxiety

  5. heart rate

    Time frame: At handover from ward to anaesthesia-/ cathlab team

    heart rate

  6. Patient and parent reported outcome and experience measure

    Time frame: Between admission to the ward and handover to anaesthesia/ cathlab-team

    experience on the ward

  7. Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians

    Time frame: From admission to the ward until sedation/ anaesthesia

    Assessment by the team of the ward and the anaesthesia-/ cathlab-team

  8. Follow up

    Time frame: 2 weeks after surgery / cathlab procedure

    Assessment of the preoperative/ preinterventional phase by the child and/ or caregiver via telephone interview 2 weeks after surgery/ cathlab procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Maren Kleine-Brueggeney, Prof. Dr.

CONTACT

[email protected]

+493045932618

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: GETREADY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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