- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646565
Psychosocial Development of Children Undergoing Open Cardiac Surgery
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.
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Budapest, Hungary
- Semmelweis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Well-being measured with the KidScreen52 questionnaire
Time Frame: 11-15 years after the intervention
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Items scored on a 5-point scale ranging from never / not at all to always. 10 dimensions (no. of items)
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11-15 years after the intervention
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Illness representation measured with PRISM-D and person/organ test
Time Frame: 11-15 years after the intervention
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PRISM-D; person/organ test: both used for illness representation. Patients is given to a landscape oriented a4 white paper with a yellow circle on the left down corner. The Investigator ask the patient to imagine that the white paper his/her life and the yellow circle is him/herself. Than patient instructed to first draw another circle with red that represent him/her illness. Than the investigator asks him/her to draw all the people and things important to him/her at this very moment in his life by using different colors. Scored based on the distance, size, etc. According to the person/organ test' instruction the patient first have to draw him/herself, than his/her heart. Based on the location of the organ, and it's distance from the body scoring is made. |
11-15 years after the intervention
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ChildrenHeart
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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