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Pain in Patients With Cystic Fibrosis in Rouen University Hospital — MUCODOL  

Pain Clinical Trial

Official title:
Pain in Patients With Cystic Fibrosis in Rouen University Hospital

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

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