Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03646565
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2018-08-23
Brief Title:
Psychosocial Development of Children Undergoing Open Cardiac Surgery
Sponsor:
Semmelweis University Heart and Vascular Center
Organization:
Semmelweis University Heart and Vascular Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-ST KidScreen questionnaire PRISM-D and personorgan 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
Psychosocial measures will be as follows Beck Depression Inventory BDI Spielberger State-Trait Anxiety Inventory STAI-ST KidScreen questionnaire PRISM-D and personorgan 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None