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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Completed

CT.gov ID

NCT04561973

Collaborator

(none)

109

Enrollment

Location

11.9

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Cystic Fibrosis	Behavioral: numerical rating scale

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.

Study Design

Study Type:

Observational

Actual Enrollment :

109 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pain in Patients With Cystic Fibrosis in Rouen University Hospital

Actual Study Start Date :

Nov 4, 2019

Actual Primary Completion Date :

Oct 15, 2020

Actual Study Completion Date :

Nov 1, 2020

Outcome Measures

Primary Outcome Measures

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 [14 days]
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 Outcome Measures

To assess the correlation between pain and disease severity [14 days]
The disease severity is estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator), collected in the patient's medical record. The correlation between pain and the disease severity will be studied with a Spearman's correlation coefficient.
To assess the correlation between pain and the age of the patient. [14 days]
Age of the patient is collected using the medical file. The correlation between pain and the age will be studied with a Spearman's correlation coefficient.
To describe the pain locations. [14 days]
Pain locations are evaluated using the prospective diary and the self-administered retrospective questionnaire.
To describe the use of pharmacological or nonpharmacological treatment. [14 days]
The pharmacological or nonpharmacological treatments are evaluated using the prospective diary (did you take a treatment for that pain episode ?) and the self-administered retrospective questionnaire. The efficacity of the treatment is evaluated with the diary (relief or not) et the questionnaire (Likert-type rating scale : Always, often, rarely, never).
To evaluate the procedural pain. [3 months]
The procedural pain and the proposed pain treatment are evaluated using the self-administered retrospective questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.