Research with human participants

Overview of medical research in the Netherlands

A comparison of internalizing symptoms with children with a Somatoform disorder and children with a chronic disease

Published:
Last updated:

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Ethical review
Approved WMO
Status
Pending
Health condition type
Somatic symptom and related disorders
Study type
Observational non invasive

ID

NL-OMON32103

Source

ToetsingOnline

Brief title

A comparison of SD children and children with a chronic disease

Condition

  • Somatic symptom and related disorders

Synonym

functional complaints, unexplained physical complaints

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Het onderzoek wordt niet gefinancieerd. Het vindt intern plaats binnen Curium

Intervention

Keyword :
children and parents, chronic disease, emotional disorders, Somatoform disorders

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Study burden and risks

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Public
Leids Universitair Medisch Centrum

Endegeesterstraatweg 27
2342 AK Oegstgeest
Nederland
Scientific
Leids Universitair Medisch Centrum

Endegeesterstraatweg 27
2342 AK Oegstgeest
Nederland

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Children (2-11 years)

Inclusion criteria

- 20 patients of Curium with the diagnose Somatoform disorder
- 40 patients of the LUMC with a chronic somatic disease

Exclusion criteria

Children with a Somatoform disorder
- diagnose Somatoform disorder
- between 7-18 years old;Children with a chronic somatic disease:
- between 7-18 years old
- The somatic complaints should be similar to those of the included SD patients, like chronic fatigue, abdominal pain and nausea. This could for example be children who have auto-immune diseases or chronic abdominal diseases.

Design

Study type :
Observational non invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
60
Type :
Anticipated

Approved WMO
Application type :
First submission
Review commission :
METC Leids Universitair Medisch Centrum (Leiden)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL20698.058.07