Evaluation of the preoperative preparations for paediatric cardiac surgery and paediatric cardiac catheter laboratory interventions

Evaluation of the preoperative preparations for paediatric cardiac surgery and paediatric cardiac catheter laboratory interventions - GETREADY

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035813

Enrollment

200

Registered

2025-01-02

Start date

2025-01-09

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital cardiac malformations

Interventions

Group 1: All the children who will receive either cardiac surgery or an intervention in the cardiac catheter laboratory in the Deutsches Herzzentrum der Charite

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: All the children undergoing elective heart surgery or cardiac catheter interventions.

Exclusion criteria

Exclusion criteria: already intubated or tracheostomised children under sedation; children and families who do not possess enough command of the German language in order to fully understand and consent for the study or who couldn't fill in the required questionnaires. Emergency procedures. Death of the child.

Design outcomes

Primary

Measure	Time frame
The primary outcome consists in quantifying the preoperative or preinterventional emotional state of the child by using the Parental Separation Anxiety Scale (PSAS Scale).	—

Secondary

Measure	Time frame
Secondary outcomes are represented by scoring on other scales meant to characterise the preoperative state of the child (University of Michigan Sedation Scale, HRAD +/- Scale, Modified Yale Preoperative Anxiety Scale – Short Form (mYPAS-SF), as well as the self evaluation of preoperative anxiety by the older children in the cohort using a Faces or a Visual Analog Scale. The children and their parents will receive a follow up interview 2 weeks after the procedure (or later in the case of prolonged ICU stays) where they will be asked about their experiences in the lead up to the procedure or operation. The medical teams on the wards, the catheter lab and in the operating room will be asked about the transfer of the child from the ward and the induction of sedation or anaesthesia. Additionally, the parents will be asked to complete a questionnaire about their experience of the preoperative phase. Lastly, physiological parameters like heart rate, oxygen saturations, the need for supplimentary oxygen and any complications will also be recorded.	—

Measure

Time frame

Secondary outcomes are represented by scoring on other scales meant to characterise the preoperative state of the child (University of Michigan Sedation Scale, HRAD +/- Scale, Modified Yale Preoperative Anxiety Scale – Short Form (mYPAS-SF), as well as the self evaluation of preoperative anxiety by the older children in the cohort using a Faces or a Visual Analog Scale. The children and their parents will receive a follow up interview 2 weeks after the procedure (or later in the case of prolonged ICU stays) where they will be asked about their experiences in the lead up to the procedure or operation. The medical teams on the wards, the catheter lab and in the operating room will be asked about the transfer of the child from the ward and the induction of sedation or anaesthesia. Additionally, the parents will be asked to complete a questionnaire about their experience of the preoperative phase. Lastly, physiological parameters like heart rate, oxygen saturations, the need for supplimentary oxygen and any complications will also be recorded.

—

Countries

Germany

Contacts

Public ContactMaren Kleine-Brüggeney

Deutsches Herzzentrum der Charite

maren.kleine-brueggeney@dhzc-charite.de+49 3045932618

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026