Pain in Patients With Cystic Fibrosis in Rouen University Hospital

Pain Clinical Trial

— MUCODOL  

Official title:

Pain in Patients With Cystic Fibrosis in Rouen University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561973
• Other study ID #: 2019/318/OB
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: May 2021
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 1, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pain

Intervention

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.

Locations

Country	Name	City	State
France	CHU	Rouen	Nomandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	14 days
Secondary	To assess the correlation between pain and disease severity	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.	14 days
Secondary	To assess the correlation between pain and the age of the patient.	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.	14 days
Secondary	To describe the pain locations.	Pain locations are evaluated using the prospective diary and the self-administered retrospective questionnaire.	14 days
Secondary	To describe the use of pharmacological or nonpharmacological treatment.	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).	14 days
Secondary	To evaluate the procedural pain.	The procedural pain and the proposed pain treatment are evaluated using the self-administered retrospective questionnaire.	3 months