Psychological Study in Children With Mucoviscidosis

NCT05948488 | Completed

• 2 other identifiers: RC31/18/03042018-A02216-49
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Children; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Links between pain-related fears and pain during care

  1 day

• Links between pain during care and quality of life

  1 day

• Links between pain during care and the severity of the disease

  1 day

• Links between the severity of the disease and anxiety

  1 day

• Links between parents' anxiety and the child's anxiety

  1 day

Study Arms (1)

Children with cystic fibrosis

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

Other: Questionnaires

Interventions

Questionnaires OTHER

The questionnaires focus on anxiety, fear and quality of life.

Children with cystic fibrosis

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Under 8 or over 18 years of age
• Presence of chronic co-morbidities
• Difficulty reading and understanding French
• Objection to taking part in research

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Géraldine LABOURET

Toulouse, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pain; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Géraldine LABOURET, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 17, 2023
• Study Start: February 28, 2019
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

FR (1)