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Clinical Trial Summary

Objectif Principal - To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France. Objectifs secondaires - To assess the relationship between pain and disease severity. - To assess the relationship between pain and the age of the patient. - To describe the pain locations. - To describe the use of pharmacological or nonpharmacological treatment. - To evaluate the procedural pain.


Clinical Trial Description

Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit. Primary evaluation criteria : Intensity and frequency of pain are evaluated with the prospective diary. - The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported - The pain frequency is completed twice a day (morning and evening) on the prospective pain diary. Secondary evaluation criteria - The disease severity, estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator, collected in the patient's medical record) - Pain locations, pharmacological or nonpharmacological treatment and procedural pain are evaluated using the diary and the questionnaire. - Demographic data and characteristics of cystic fibrosis are collected using the medical file. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04561973
Study type Observational
Source University Hospital, Rouen
Contact
Status Completed
Phase
Start date November 4, 2019
Completion date November 1, 2020

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