Chronic Pain in Children and Adolescents.

NCT ID: NCT02547415

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-22
• Study Completion Date: 2018-01-10

Brief 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.

Detailed 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

Conditions

Pain, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with questionnaires and psychological testing

children and adolescents with chronic pain without proven medical cause, type painful somatic complaints

questionnaires and psychological testing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Marie PERRIN

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

Hospices Civils de LYON

Bron, , France

Hopital TROUSSEAU

Paris, , France

Hopital NECKER

Paris, , France

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2014-A01384-43

Identifier Type: OTHER

Identifier Source: secondary_id

1408152

Identifier Type: -

Identifier Source: org_study_id