Skip to main content
OpenTrials
Completed

NCT Number: NCT02547415

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de LYON, Bron, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires and psychological testing

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.

Primary outcomes

  1. Explanatory factors for pain

    Time frame: 1 month

    Environmental, familial, personal factors in children with chronic pain

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: PEDOUL

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2015
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.