Psychological Study in Children With Mucoviscidosis

Cystic Fibrosis Clinical Trial

— DoulAnxMuco  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948488
• Other study ID #: RC31/18/0304
• Secondary ID: 2018-A02216-49
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: August 28, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Questionnaires
The questionnaires focus on anxiety, fear and quality of life.

Locations

Country	Name	City	State
France	Géraldine LABOURET	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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