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Recruiting Not applicable

Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases

NCT06884046 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-02-06
Last updated
2025-03-19

Condition(s) studied

Complex Congenital Heart Disease

Investigational drug(s) / intervention(s)

Personalized support project

Personalized support project: 1. Presence of a child nurse at the consultation of the anesthesiologist-resuscitator. 2. Antenatal paramedical consultation conducted by a child nurse composed of a semi-structured interview and an evaluation of Parental Stress by the ISP-4 self-questionnaire. 3. Implementation of the personalized support project 4. Self-assessment of parental stress using the ISP-4 self-questionnaire (child admitted to intensive care or resuscitation unit) 5. Application of the personalised support project 6. Self-assessment of parental stress using the ISP-4 self-questionnaire (child discharged from intensive care) 7. Paramedical follow-up consultation with parents (semi-directive interview, ISP-4 self-questionnaire) and assessment of the child's psychomotor development in the child's 6th month of life

Study summary

Half of children with congenital heart disease develop specific neurodevelopmental disorders. Neurodevelopmental disorders are the leading cause of morbidity in these children. They can be increased by perioperative complications, the family and economic socio-economic environment and the level of parental stress. The stress perceived by parents of children with congenital heart disease varies depending on the time of diagnosis, the organization of care inherent in neonatal management and the type of pathology diagnosed.

The main objective is to evaluate the feasibility of a multidisciplinary and personalised model of support for parental stress, from the ante-natal period, in the context of their child's neonatal cardiac surgery.

Eligibility

Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
No
Inclusion Criteria: * Parents whose fetus has congenital heart disease diagnosed in antenatal, which will be operated in the neonatal period (between 0 and 28 days of life) within our sector. * Parents followed in the congenital heart disease sector of the University Hospital of Bordeaux as soon as the diagnosis is announced in antenatal. * Free, informed and signed written consent of the couple or single mother in a single parent setting or by a third person (in case of physical disability of the participant) and the investigator (no later than the day of inclusion and before any examination required by the research). * Person affiliated or beneficiary of a social security scheme (excluding AME). * Parents with parental authority. Exclusion Criteria: * Parents who do not understand or read French and cannot be accompanied by a third party for translation. * Parents with major psychiatric disorders. * Parents deprived of liberty due to ongoing legal proceedings. * Parents under guardianship or curatorship or unable to personally express consent.

Primary outcome measure(s)

  • Families participation evaluation — at the last protocol visit ( visit 6 - day 180)
    The participation of families in the proposed accompaniment will be evaluated by the participation rate: number of parents who participated in the study until the last stage of the protocol, number of parents who dropped out of the study and reason.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Cardiologique Haut-Lévêque Pessac France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884046 on ClinicalTrials.gov ↗ ← All trials in France