Pain in Patients With Cystic Fibrosis in Rouen University Hospital

NCT ID: NCT04561973

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2020-11-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
• Seen for routine planned visits.
• Having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors

Exclusion Criteria

• Patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized.
• Major patient under legal protection.
• Major patient having problems understanding the oral and written French language or child whose parents or legal representatives have problems understanding the oral and written French language.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU

Rouen, Nomandie, France

Countries

France

Other Identifiers

2019/318/OB

Identifier Type: -

Identifier Source: org_study_id