Pain in Patients With Cystic Fibrosis in Rouen University Hospital

NCT04561973 | Completed

• 1 other identifier: 2019/318/OB
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Cystic Fibrosis

Keywords

pain; cystic fibrosis; epidemiology; adults; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To assess the correlation between pain and disease severity

  14 days

• To assess the correlation between pain and the age of the patient.

  14 days

• To describe the pain locations.

  14 days

• To describe the use of pharmacological or nonpharmacological treatment.

  14 days

• To evaluate the procedural pain.

  3 months

Interventions

numerical rating scale BEHAVIORAL

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU

Rouen, Nomandie, 76000, France

Location

MeSH Terms

Conditions

Pain; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 24, 2020
• Study Start: November 4, 2019
• Primary Completion: October 15, 2020
• Study Completion: November 1, 2020
• Last Updated: February 21, 2022

Record last verified: 2021-05

Locations

FR (1)