CHU
Rouen, Nomandie, 76000, France
NCT Number: NCT04561973
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
* To assess the relationship between pain and disease severity. * To assess the relationship between pain and the age of the patient. * To describe the pain locations. * To describe the use of pharmacological or nonpharmacological treatment. * To evaluate the procedural pain.
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Observational
Rouen, Nomandie, 76000, France
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.
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
Secondary evaluation criteria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
Pain locations are evaluated using the prospective diary and the self-administered retrospective questionnaire.
Time frame: 14 days
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).
Time frame: 3 months
The procedural pain and the proposed pain treatment are evaluated using the self-administered retrospective questionnaire.
University Hospital, Rouen
Other
Acronym: MUCODOL
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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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