Clinical trial NCT03646565: Psychosocial Development of Children Undergoing Open Cardiac Surgery
Official title: A Longitudinal Study and Follow-up of the Psychosocial Development and Investigation of the Wellbeing of Children Undergoing Open Cardiac Surgery in Their Early Ages.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included school-aged children treated and followed in the Gottsegen György Hungarian Institute of Cardiology in Budapest. The operated subgroup enrolled patients who underwent open chest cardiac surgery, under the age of four, between 2003-2007

Brief summary: In recent years, improvement of medical treatments leads to the effect, that 90% of children originally born with congenital heart disease (CHD) are reaching adulthood. Mortality rates have significantly decreased in the last decades. However several studies have shown that with multiple consequences have to face the survivors. Eg. neuronal and psychological injuries during the perioperative period. After all, the surgical interventions that save their lives might result in psychological and behavioral deviations and increased morbidity, which is strongly worsening the quality of life, learning abilities and behavioral development of these patients. Not yet available any clinical guidelines for managing or screening these patients for designing intervention, taking corrective actions.

The investigators wish to identify those perioperative factors that might affect the well-being, coping, the behavior alteration and psychosocial status of children, who underwent open chest cardiac interventions in early ages. The investigators also wish to understand the long-term changes of the illness-representation of this population and to see its effect for the wellbeing and coping.

Detailed description: The study population will include school-aged children treated and followed in the Gottsegen György Hungarian Institute of Cardiology in Budapest. The participants will be selected from patients who underwent open-chest cardiac surgery, under the age of four, between 2003- 2007 and once followed up in 2013-2014.

Psychosocial measures will be as follows: Beck Depression Inventory (BDI), Spielberger State-Trait Anxiety Inventory (STAI-S/T), KidScreen questionnaire, PRISM-D and person/organ test.

A range of perioperative and psychosocial factors will be assessed as potential determinants of outcome. The data will be fully retrieved from the registries of our hospital center. Characteristics registered included pre-, intra- and postoperative variables such as age, gender, comorbidities (renal, hepatic, infectious, neurological, metabolic, hormonal or genetic disorders), type of surgery, laboratory parameters, operation time, cardiopulmonary bypass (CPB) time, aortic cross-clamp time, Risk Assessment for Congenital Heart Surgery (RACHS) points, length of mechanical ventilation, blood loss, transfusions, fluid balance, need for inotropic support or pulmonary vasodilatation, medications, anaesthetic and analgesic agents.

By comparing the above mentioned perioperative data with the result of the psychological measures we expect to answer our hypothesis.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent open-chest heart surgery between 2003-2007
* Operated patients (surgery made between 2003-2007) who had been followed up by the institution between 2013-14. and filled in the psychological questionnaires

Exclusion Criteria:

- Patients who had not been followed up by the institution between 2013-14 and thus had not filled the psychological questionnaires

Primary outcomes:
measure: Well-being measured with the KidScreen52 questionnaire
timeFrame: 11-15 years after the intervention
measure: Illness representation measured with PRISM-D and person/organ test
timeFrame: 11-15 years after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References: