Chronic Pain in Children and Adolescents.

Pain, Chronic Clinical Trial

— PEDOUL  

Official title:

Study of Characteristics of Medically Unexplained Chronic Pain in Children and Adolescents.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547415
• Other study ID #: 1408152
• Secondary ID: 2014-A01384-43
• Status: Completed
• Start date: January 22, 2015
• Est. completion date: January 10, 2018

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Medically unexplained chronic pain - without identifiable somatic origin - is yet an insufficiently known and explored field in children and adolescents by international clinical works. This research aims to characterize somatic, psychological, psychopathological and environmental (particularly attachment styles and family functioning) processes trough an observational study with three pain management centers.

The study concerns children and adolescents from 7 to 17 years old, suffering of medically unexplained chronic pain and their parents who are referred to a pain center. It is composed of a somatic, psychological and family functioning assessment on the one hand and psychopathological and attachment evaluation on the other hand.

Description:

Participation in the study involves an additional visit to 1 day pain center to answer questionnaires about anxiety, family environment, depression and psychological testing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children and adolescent with chronic pain no proven medical cause, type of painful somatic complaints within the scope of one of the following diagnoses to ICD-10 (International Classification of Diseases) and DSM-IV and DSM-V (Diagnostic and Statistical Manual of Mental Disorders) to somatoform disorders, distinguishing between :

• pain disorder

• somatoform disorder

• undifferentiated somatoform disorder

• Addressed to the pain centers or in pediatric chronic pain services hosting children.

• being fluently French-speaking and French-reading

Exclusion Criteria:

presence of current or past organic pathology including migraines and epilepsy, which may interfere with somatic expression of studied disorder

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Other:
• questionnaires and psychological testing
Child/adolescent and parents interview and consultation with both a physician and a psychologist for a somatic and pain indicators assessment within an usual setting. Then, parents and child or adolescent are interviewed separately using different psychological instruments with only a psychologist: Psychological (cognitive and projective evaluation) : Intellectual Quotient, mental flexibility, projective evaluation with Rorschach and Thematic Apperception Test, parents and children attachment questionnaires Psychopathological: anxiety and depression questionnaires, psychiatric disorders evaluation, quality of life, life events questionnaires, family functioning interview.

Locations

Country	Name	City	State
France	Hospices Civils de LYON	Bron
France	Hopital NECKER	Paris
France	Hopital TROUSSEAU	Paris
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explanatory factors for pain	Environmental, familial, personal factors in children with chronic pain	1 month