Cardiac SurgeryNCT03646565
Psychosocial Development of Children Undergoing Open Cardiac Surgery
An observational study of Cardiac Surgery, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cardiac Surgery
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 20 Nov 2018to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Patients who had not been followed up by the institution between 2013-14 and thus had not filled the psychological questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Cardiac Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being measured with the KidScreen52 questionnaire
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.
Measured: 11-15 years after the intervention
Illness representation measured with PRISM-D and person/organ test
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.
Measured: 11-15 years after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Nov 2018
- Primary completion20 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646565
- Sponsor's protocol ID
- ChildrenHeart
- Status last verified
- Jan 2022
- First submitted
- 23 Aug 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03646565
- Acronym / sponsor ID
- ChildrenHeart
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who had not been followed up by the institution between 2013-14 and thus had not filled the psychological questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being measured with the KidScreen52 questionnaire (time frame: 11-15 years after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.