NCT04561973

Pain in Patients With Cystic Fibrosis in Rouen University Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain
• Cystic Fibrosis

Interventions

Type	Name	Description
BEHAVIORAL	numerical rating scale	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.

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-10-15
• Completion: 2020-11-01
• First posted: 2020-09-24
• Last updated: 2022-02-21

Locations

1 site across 1 country: France