PEDOUL: Chronic Pain in Children and Adolescents.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02547415

Collaborator

(none)

Enrollment

Locations

35.6

Actual Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic	Other: questionnaires and psychological testing

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

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 22, 2015

Actual Primary Completion Date :

Jan 10, 2018

Actual Study Completion Date :

Jan 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
patients with questionnaires and psychological testing children and adolescents with chronic pain without proven medical cause, type painful somatic complaints	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.

Arm

Intervention/Treatment

patients with questionnaires and psychological testing

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

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.

Outcome Measures

Primary Outcome Measures

Explanatory factors for pain [1 month]
Environmental, familial, personal factors in children with chronic pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospices Civils de LYON	Bron	France	69500
2	Hopital TROUSSEAU	Paris	France	75012
3	Hopital NECKER	Paris	France	75015
4	CHU de SAINT-ETIENNE	Saint-etienne	France	42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Anne-Marie PERRIN, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02547415

Other Study ID Numbers:

1408152
2014-A01384-43

First Posted:

Sep 11, 2015

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Pain, Chronic

children

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Sep 16, 2021