Pain in Patients With Cystic Fibrosis in Rouen University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults followed at the cystic fibrosis center of Rouen University Hospital, Normandy, France.
- •Seen for routine planned visits.
- •Having expressed their non-opposition or whose non-opposition was expressed by the parents or legal representatives for minors
排除标准
- •Patients seen for an acute episode or exacerbation outside of routine planned visits or patient hospitalized.
- •Major patient under legal protection.
- •Major patient having problems understanding the oral and written French language or child whose parents or legal representatives have problems understanding the oral and written French language.
结局指标
主要结局
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
时间窗: 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.
次要结局
- To assess the correlation between pain and disease severity(14 days)
- To assess the correlation between pain and the age of the patient.(14 days)
- To evaluate the procedural pain.(3 months)
- To describe the pain locations.(14 days)
- To describe the use of pharmacological or nonpharmacological treatment.(14 days)