Chronic Pain in Children and Adolescents. (PEDOUL)

September 14, 2021 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hospices Civils de Lyon
      • Paris, France, 75015
        • Hopital Necker
      • Paris, France, 75012
        • Hôpital Trousseau
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescent with chronic pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explanatory factors for pain
Time Frame: 1 month
Environmental, familial, personal factors in children with chronic pain
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Anne-Marie PERRIN, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2015

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408152
  • 2014-A01384-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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