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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

167 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rare Diseases

Keywords

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rare diseases pediatric surgery children and adolescent quality of life psychological distress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Families of rare chronically ill children

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.

No interventions assigned to this group

Families in the comparative control group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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

* 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.

\- Families of children with a congenital or chronic disease.

Minimum Eligible Age

1 Day

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Johannes Boettcher

Principial investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Boettcher J, Nazarian R, Fuerboeter M, Liedtke A, Wiegand-Grefe S, Reinshagen K, Boettcher M. Mental Health of Siblings of Children with Rare Congenital Surgical Diseases during the COVID-19 Pandemic. Eur J Pediatr Surg. 2022 Oct;32(5):422-428. doi: 10.1055/s-0041-1740978. Epub 2021 Dec 31.

Reference Type DERIVED

PMID: 34972234 (View on PubMed)

Other Identifiers

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PV7161

Identifier Type: -

Identifier Source: org_study_id