Skip to content

Psychological Study in Children With Mucoviscidosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05948488
Acronym
DoulAnxMuco
Enrollment
160
Registered
2023-07-17
Start date
2019-02-28
Completion date
2022-08-28
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, Children, Pain, Anxiety

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.

Interventions

OTHERQuestionnaires

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Links between pain during care and anxiety1 dayPain 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

MeasureTime frameDescription
Links between pain-related fears and pain during care1 dayPain 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.
Links between pain during care and quality of life1 dayPain 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.
Links between pain during care and the severity of the disease1 dayPain 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.
Links between the severity of the disease and anxiety1 dayAnxiety 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.
Links between parents' anxiety and the child's anxiety1 dayParent'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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026