Psychosocial Development of Children Undergoing Open Cardiac Surgery

NCT03646565 | Completed

• 1 other identifier: ChildrenHeart
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  11-15 years after the intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Semmelweis University

Budapest, Hungary

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: November 20, 2018
• Primary Completion: March 20, 2020
• Study Completion: April 30, 2020
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

HU (1)