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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02216-49 | Other Identifier | ID-RCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with cystic fibrosis | Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | The questionnaires focus on anxiety, fear and quality of life. |
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| 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 |
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.
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| Name | Affiliation | Role |
|---|---|---|
| Géraldine LABOURET, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Géraldine LABOURET | Toulouse | France |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |