Quality of Life in Cardiac Pediatric Patients Attending Assuit Univeristy Hospital

NCT ID: NCT04354844

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

Brief Summary

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2)

Detailed Description

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2) Diagnosis of a life-threatening illness during a child's formative years can have far-reaching effects that ripple through the family and across a lifetime. Infants with complex CHD experience a range of uncommon and painful events, such as separation from their mother at birth, urgent transfer to specialized intensive care, frequent invasive medical procedures, feeding difficultiesand withdrawal from narcotic pain relief. These earlylife experiences can have profound consequences for the developing child, shaping brain development, the body's immune system and responses to stress.(5) From a neurodevelopmental perspective, children with CHD experience greater difficulties compared with their healthy peers. The risk and severity of neurodevelopmental impairment increases with greater CHD complexity, the presence of a genetic disorder or syndrome, and greater psychological stress. During infancy, the most pronounced difficulties occur in motor functioning. By early childhood, studies show that children with complex CHD have an increased risk of neurodevelopmental impairment, in fine and gross motor skills, and language, attention, executive functioning, emotion regulation and behaviour.(7)

Conditions

Quality of Life

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cyanotic and acyanotic group

questinnaire

questionnaire

Intervention Type: BEHAVIORAL

questionnaire

Interventions

questionnaire

questionnaire

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• - Infants of both sex.
• Age :from 2 years to 18 years.
• Attending Assuit University Children Hospital including NICU, pediatric cardiology department, outpatient clinics.
• Patients diagnosed with congenital heart disease (cyanotic, acyanotic, cardiomyopathy, rheumatic heart).

Exclusion Criteria

• - patients suspected to have congenital heart but excluded on echo diagnosis. patient with any associated lesions (patients have any congenital anomalies with congenital heart like down syndrome)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nardeen Emad Elway

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Davis CC, Brown RT, Bakeman R, Campbell R. Psychological adaptation and adjustment of mothers of children with congenital heart disease: stress, coping, and family functioning. J Pediatr Psychol. 1998 Aug;23(4):219-28. doi: 10.1093/jpepsy/23.4.219.

Reference Type: BACKGROUND

PMID: 9718895 (View on PubMed)

Gee DG, Gabard-Durnam LJ, Flannery J, Goff B, Humphreys KL, Telzer EH, Hare TA, Bookheimer SY, Tottenham N. Early developmental emergence of human amygdala-prefrontal connectivity after maternal deprivation. Proc Natl Acad Sci U S A. 2013 Sep 24;110(39):15638-43. doi: 10.1073/pnas.1307893110. Epub 2013 Sep 9.

Reference Type: BACKGROUND

PMID: 24019460 (View on PubMed)

Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.

Reference Type: BACKGROUND

PMID: 22851541 (View on PubMed)

Other Identifiers

qolicp

Identifier Type: -

Identifier Source: org_study_id