Congenital Heart Disease in ChildrenGETREADYNCT07414251
Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization
An observational study of Congenital Heart Disease in Children, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease in Children
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2025to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing cardiac surgery or cardiac catheterization.
Who may be able to join
- All children undergoing cardiac surgery or cardiac catheterization.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
DHZC, Charité Universtiätsmedizin Berlin
Berlin, State of Berlin, 10553
About this study
Official title: 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.
- Conditions
- Congenital Heart Disease in Children
- Keywords
- anxiety, congenital heart disease, PROMS, PREMS
- Medical subject headings
- Anxiety Disorders, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | 100 children assessed in 2025 | |
| Follow up | 100 children to be assessed in 2026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Separation Anxiety Scale
PSAS; Preoperative anxiety level; scale from 1 (not anxious) to 4 (crying, fighting) plus necessity to administer propofol for separation
Measured: At handover from ward to anaesthesia-/ cathlab-team
Secondary outcomes (8)
University of Michigan Sedation Score
UMSS, 5 point score from awake (0) to unarousable (4)
Measured: 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
Measured: at handover from ward to anaesthesia or cathlab-team
Faces scale
Faces scale (pictures of different faces) for children to express how they feel
Measured: 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
Measured: At handover of child from ward to anaesthesia-/ cathlab team
heart rate
heart rate
Measured: At handover from ward to anaesthesia-/ cathlab team
Patient and parent reported outcome and experience measure
experience on the ward
Measured: 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
Measured: 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
Measured: 2 weeks after surgery / cathlab procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start9 Jan 2025
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Maren Kleine-Brüggeney, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414251
- Sponsor's protocol ID
- EA2/209/24
- Other IDs
- DRKS00035813
- Acronym
- GETREADY
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures
- ClinicalTrials.gov ID
- NCT07414251
- Acronym / sponsor ID
- GETREADY / EA2/209/24
- Conditions
- Congenital Heart Disease in Children
- Keywords
- anxiety, congenital heart disease, PROMS, PREMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | –100 children assessed in 2025 |
| Follow up | – | –100 children to be assessed in 2026 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing cardiac surgery or cardiac catheterization.
Key inclusion criteria (1 listed)
- All children undergoing cardiac surgery or cardiac catheterization.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
University of Michigan Sedation Score
Time frame: At handover from ward to anaesthesia-/ cathlab-team
Modified Yale Preoperative Anxiety Scale - Short Form
Time frame: at handover from ward to anaesthesia or cathlab-team
Faces scale
Time frame: At handover from ward to anaesthesia-/ cathlab-team
VAS anxiety scale
Time frame: At handover of child from ward to anaesthesia-/ cathlab team
heart rate
Time frame: At handover from ward to anaesthesia-/ cathlab team
Patient and parent reported outcome and experience measure
Time frame: Between admission to the ward and handover to anaesthesia/ cathlab-team
Assessment of preoperative phase and anxiety/ wellbeing of the child by clinicians
Time frame: From admission to the ward until sedation/ anaesthesia
Follow up
Time frame: 2 weeks after surgery / cathlab procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Separation Anxiety Scale (time frame: At handover from ward to anaesthesia-/ cathlab-team). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.