Psychological Study in Children With Mucoviscidosis (DoulAnxMuco)

Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis

Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.

The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Géraldine LABOURET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.

Description

Inclusion Criteria:

• Have cystic fibrosis
• Child aged over 8 years and under 18 years
• Presence of at least one parent at the time of inclusion
• To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
• Do not object to the research

Exclusion Criteria:

• Under 8 or over 18 years of age
• Lack of at least one parent at the time of inclusion
• Presence of chronic co-morbidities
• Difficulty reading and understanding French
• Objection to taking part in research

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with cystic fibrosis; Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.	Other: Questionnaires; The questionnaires focus on anxiety, fear and quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Links between pain during care and anxiety	Pain during care is assessed using the Visual Analogic Scale (VAS) and anxiety using the State Trait Anxiety Inventory (STAI) scale. The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain". The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Links between pain-related fears and pain during care	Pain related fears is assessed using the Fear of Pain Questionnaire (FOPQ) and pain during care using the Visual Analogic Scale (VAS). The Fear of Pain Questionnaire (FOPQ) is a self-assessment scale. It consists of 24 items. For item, there are five modalities : strongly disagree, disagree, don't know, agree, strongly agree. The Visual Analogic Scale (VAS) is a self-assessment scale. It takes the form of a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".	1 day
Links between pain during care and quality of life	Pain during care is assessed using the Visual Analogic Scale (VAS) and quality of life using the Cystic Fibrosis Questionnaire (CFQ). The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain". The Cystic Fibrosis Questionnaire (CFQ) composed of four modalities : always, often, sometime, never.	1 day
Links between pain during care and the severity of the disease	Pain during care is assessed using the Visual Analogic Scale (VAS) and the severity of the disease by the number of respiratory exacerbations per year. The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".	1 day
Links between the severity of the disease and anxiety	Anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale and the severity of the disease by the number of respiratory exacerbations per year. The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.	1 day
Links between parents' anxiety and the child's anxiety	Parent's anxiety and child's anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale. The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety. The scale is suitable for parents and children.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Géraldine LABOURET, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): August 28, 2022
• Study Completion (Actual): August 28, 2022

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Children; Cystic Fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: RC31/18/0304; 2018-A02216-49 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No