Pain in Patients With Cystic Fibrosis in Rouen University Hospital (MUCODOL)

February 18, 2022 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nomandie
      • Rouen, Nomandie, France, 76000
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2019

Primary Completion (ACTUAL)

October 15, 2020

Study Completion (ACTUAL)

November 1, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/318/OB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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