Psychosocial Situation of Children With Rare (Congenital) Pediatric Surgical Diseases and Their Families

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Rare Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT04382820

PV7161

Details and patient eligibility

About

Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The aim of the present research project is to examine the psychosocial burden of the children with rare (congenital) pediatric surgical diseases and their family in order to draw attention to a possible psychosocial care gap in this population.

Full description

The central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of pediatric surgery. Among the rare diseases that are included are diaphragmatic hernia, anorectal malformations, esophageal atresia, Hirschsprung's disease and biliary atresia. In order to have a comparative sample, additional data of a matched control group are collected. Central standardized psychosocial outcomes will be assessed from the perspectives of the parents, the affected child and the siblings.

Enrollment: 167 patients

Sex: All

Ages: 1 day to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (families of rare disease):

• Family with at least one child between 0 and 21 years with a rare pediatric surgical disease.
• Consent to participate in the study.
• Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (families of rare disease):

• Severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage.

Inclusion Criteria (control group):

• Family with at least one child between 0 and 21 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints
• Consent to participate in the study.
• Sufficient knowledge of the German language of parents and children.

Exclusion Criteria (control group):

• Families of children with a congenital or chronic disease.

Trial design

167 participants in 2 patient groups

Families of rare chronically ill children

Description:

Clinical study participants for the diagnostic study are patients who have sought treatment at the University Medical Center Hamburg-Eppendorf due to a rare pediatric surgical disease. Every family receives a comprehensive psychosocial diagnostic in the form of standardized instruments.

Families in the comparative control group

Description:

Participants in the healthy control sample are matched to the clinical sample in terms of age and gender. Included are families of children aged 0-21 years, who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints; such as hernia surgery or testicular relocation.