PIEKAH: A preoperative online intervention for parents of children with congenital heart defects: empowerment, relief, and networking

PIEKAH: A preoperative online intervention for parents of children with congenital heart defects: empowerment, relief, and networking - PIEKAH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037972

Enrollment

Registered

2025-09-26

Start date

2026-02-02

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Parents of children with congenital heart defects

Interventions

Group 1: Intervention group: Participation in the 8-week PIEKAH group intervention (8 weekly group sessions of 60 minutes each) Group 2: Control group: No participation in the intervention. After comp

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Parents of children with congenital heart defects - Surgical correction planned at Erlangen Children's Heart Surgery within 20 weeks - Surgery date no earlier than 12 weeks - No heart surgery performed to date

Exclusion criteria

Exclusion criteria: - Insufficient knowledge of German to understand the content of the online intervention and/or participate in the written surveys

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of the study is the change in parental psychological distress between the first (T0, preoperative & pre-intervention) and second measurement points (T1, preoperative & post-intervention) in the intervention group compared to the control group (depressive symptoms [EPDS], anxiety symptoms [State-Trait Anxiety Inventory], traumatic stress symptoms [PCL-5]).	—

Secondary

Measure	Time frame
Secondary endpoints will measure changes resulting from participation in the group intervention in the following areas: -Parental and personal stress experience (PSS, PSS-10) - Biological stress marker: change in hair cortisol levels as an indicator of stress experience - Change in parental competence experience, i.e., the subjective feeling of being able to competently cope with challenges in dealing with the child's illness (PSOC) - Relationship with the child (PBQ) - Quality of partnership (DAS) - Perceived social support and connectedness, both through the group itself and through the private or professional environment (ESSI) - Child's regulatory ability: Can a measurable change in the child be demonstrated as a result of a change in parental behavior? (IBQ)	—

Measure

Time frame

Secondary endpoints will measure changes resulting from participation in the group intervention in the following areas: -Parental and personal stress experience (PSS, PSS-10) - Biological stress marker: change in hair cortisol levels as an indicator of stress experience - Change in parental competence experience, i.e., the subjective feeling of being able to competently cope with challenges in dealing with the child's illness (PSOC) - Relationship with the child (PBQ) - Quality of partnership (DAS) - Perceived social support and connectedness, both through the group itself and through the private or professional environment (ESSI) - Child's regulatory ability: Can a measurable change in the child be demonstrated as a result of a change in parental behavior? (IBQ)

—

Countries

Germany

Contacts

Public ContactJonas Hemetsberger

Kinder- und Jugendabteilung für Psychische Gesundheit, Uniklinikum Erlangen

Jonas.hemetsberger@uk-erlangen.de+49 9131 85 39123

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026