Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychosocial Development of Children Undergoing Open Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03646565
Recruitment Status : Enrolling by invitation
First Posted : August 24, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Semmelweis University Heart and Vascular Center

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.


Condition or disease
Cardiac Surgery

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Other
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.
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Well-being measured with the KidScreen52 questionnaire [ Time Frame: 11-15 years after the intervention ]

    Items scored on a 5-point scale ranging from never / not at all to always. 10 dimensions (no. of items)

    • Physical- (5) Max. score (MS) = higher physically fit, active, healthy.
    • Psychological Well-being (6). MS = more happy, views life positively, satisfied.
    • Moods and Emotions (7). MS: more good feelings, good mood.
    • Self-Perception (5). MS: higher level of self-confident, positive body image.
    • Autonomy (5). MS: is feels free to decide, independent, autonomous.
    • Parent Relations and Home Life (6). MS: feels secure, supported and loved.
    • Social Support and Peers (6). MS: feels accepted, supported and included in peer group.
    • School Environment (6). MS: feels happy at school and doing well.
    • Social Acceptance (Bullying) (3). MS: not feeling bullied, feeling respected and accepted by peers.
    • Financial Resources (3). MS: higher security in terms of financial resources.

  2. Illness representation measured with PRISM-D and person/organ test [ Time Frame: 11-15 years after the intervention ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646565


Locations
Layout table for location information
Hungary
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center

Layout table for additonal information
Responsible Party: Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03646565     History of Changes
Other Study ID Numbers: ChildrenHeart
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No