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Chronic Pain in Children and Adolescents. (PEDOUL)

This study is currently recruiting participants.
Verified September 2016 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
ClinicalTrials.gov Identifier:
NCT02547415
First Posted: September 11, 2015
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

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 Intervention
Pain, Chronic Other: questionnaires and psychological testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Characteristics of Medically Unexplained Chronic Pain in Children and Adolescents.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Explanatory factors for pain [ Time Frame: 1 month ]
    Environmental, familial, personal factors in children with chronic pain


Estimated Enrollment: 120
Study Start Date: January 2015
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescent with chronic pain
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547415


Contacts
Contact: Anne-Marie PERRIN (0)477828391 ext +33 a.marie.perrin@chu-st-etienne.fr
Contact: Beatrice DEYGAS, CRA (0)477127655 ext +33 beatrice.deygas@chu-st-etienne.fr

Locations
France
Hospices Civils de LYON Recruiting
Bron, France, 69500
Contact: Chantal GRAGEZ-DELAFOSSE, MD         
Hopital TROUSSEAU Recruiting
Paris, France, 75012
Contact: Barbara TOURNIAIRE, MD         
Hopital NECKER Recruiting
Paris, France, 75015
Contact: Brigitte CHARRON, MD         
Sub-Investigator: Lisa OUSS         
Sub-Investigator: Elise TORDJMAN         
Sub-Investigator: Gaëlle PRUVOST-D'HEROUVILLE         
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Contact: Anne-Marie PERRIN    (0)477828391 ext +33    a.marie.perrin@chu-st-etienne.fr   
Contact: Beatrice DEYGAS, CRA    (0)477127655 ext +33    beatrice.deygas@chu-st-etienne.fr   
Sub-Investigator: Malou NAVEZ, MD         
Sub-Investigator: Chrystelle CREAC'H, MD         
Sub-Investigator: Beatrice LIETAR, MD         
Sub-Investigator: Christelle BROSSE, MD         
Sub-Investigator: Jessica MANZANARES         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Anne-Marie PERRIN CHU de SAINT-ETIENNE
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02547415     History of Changes
Other Study ID Numbers: 1408152
2014-A01384-43 ( Other Identifier: ANSM )
First Submitted: September 9, 2015
First Posted: September 11, 2015
Last Update Posted: September 26, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Pain, Chronic
children

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms