Clinical trial NCT04561973: Pain in Patients With Cystic Fibrosis in Rouen University Hospital
Official title: Pain in Patients With Cystic Fibrosis in Rouen University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Cystic Fibrosis
Keywords: pain
cystic fibrosis
epidemiology
adults
children
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France

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.

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.

Primary outcomes:
measure: 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
timeFrame: 14 days
Secondary outcomes:
measure: To assess the correlation between pain and disease severity
timeFrame: 14 days
measure: To assess the correlation between pain and the age of the patient.
timeFrame: 14 days
measure: To describe the pain locations.
timeFrame: 14 days
measure: To describe the use of pharmacological or nonpharmacological treatment.
timeFrame: 14 days
measure: To evaluate the procedural pain.
timeFrame: 3 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU
state: Nomandie
Study officials:
References: