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Completed

NCT Number: NCT05948488

Psychological Study 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.

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Key information

Conditions

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

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Géraldine LABOURET

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Links between pain during care and anxiety

    Time frame: 1 day

    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.

Secondary outcomes

  1. Links between pain-related fears and pain during care

    Time frame: 1 day

    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".

  2. Links between pain during care and quality of life

    Time frame: 1 day

    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.

  3. Links between pain during care and the severity of the disease

    Time frame: 1 day

    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".

  4. Links between the severity of the disease and anxiety

    Time frame: 1 day

    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.

  5. Links between parents' anxiety and the child's anxiety

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: DoulAnxMuco

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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