Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objectif Principal
- To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
Objectifs secondaires
Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.
Primary evaluation criteria :
Intensity and frequency of pain are evaluated with the prospective diary.
The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10).
0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported
The pain frequency is completed twice a day (morning and evening) on the prospective pain diary.
Secondary evaluation criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| numerical rating scale | Behavioral | Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the intensity and frequency of pain episodes in patients with cystic fibrosis followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France | Intensity and frequency of pain are evaluated with the prospective diary. The pain intensity is assessed by validated scales adapted to the patient's age (scale ranging from 0 to 10). 0 to 6 years : numerical rating scale assessed by the parents. 4 to 7 years : Faces Pain Scale Revised. Children 6 years and older, adolescents and adults: numerical rating scale self-reported The pain frequency is completed twice a day (morning and evening) on the prospective pain diary. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the correlation between pain and disease severity | The disease severity is estimated using recent forced expiratory volume in one second (FEV1) (best measurement of the year before bronchodilator), collected in the patient's medical record. The correlation between pain and the disease severity will be studied with a Spearman's correlation coefficient. | 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Rouen | Nomandie | 76000 | France |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| To assess the correlation between pain and the age of the patient. | Age of the patient is collected using the medical file. The correlation between pain and the age will be studied with a Spearman's correlation coefficient. | 14 days |
| To describe the pain locations. | Pain locations are evaluated using the prospective diary and the self-administered retrospective questionnaire. | 14 days |
| To describe the use of pharmacological or nonpharmacological treatment. | The pharmacological or nonpharmacological treatments are evaluated using the prospective diary (did you take a treatment for that pain episode ?) and the self-administered retrospective questionnaire. The efficacity of the treatment is evaluated with the diary (relief or not) et the questionnaire (Likert-type rating scale : Always, often, rarely, never). | 14 days |
| To evaluate the procedural pain. | The procedural pain and the proposed pain treatment are evaluated using the self-administered retrospective questionnaire. | 3 months |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |