Chronic Pain in Children and Adolescents.
PEDOUL
Study of Characteristics of Medically Unexplained Chronic Pain in Children and Adolescents.
2 other identifiers
observational
30
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2015
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2015
CompletedFirst Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2018
CompletedSeptember 16, 2021
September 1, 2021
3 years
September 9, 2015
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Explanatory factors for pain
Environmental, familial, personal factors in children with chronic pain
1 month
Study Arms (1)
patients with questionnaires and psychological testing
children and adolescents with chronic pain without proven medical cause, type painful somatic complaints
Interventions
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.
Eligibility Criteria
Children and adolescent with chronic pain
You may qualify if:
- 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
You may not qualify if:
- presence of current or past organic pathology including migraines and epilepsy, which may interfere with somatic expression of studied disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospices Civils de LYON
Bron, 69500, France
Hopital TROUSSEAU
Paris, 75012, France
Hopital NECKER
Paris, 75015, France
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Marie PERRIN
CHU de SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
January 22, 2015
Primary Completion
January 10, 2018
Study Completion
January 10, 2018
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share