Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,079
- 试验地点
- 1
- 主要终点
- 11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
研究概览
简要总结
This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving the procedures included in this study as a part of their standard care
- •Patients that have expressed their consent to participate to the study by signing the informed consent document
排除标准
- •Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) < 20
- •Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;
- •Not adequately controlled background pain (average NRS in the last 24 hours is > 4)
- •Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)
结局指标
主要结局
11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)
时间窗: Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour
Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).
次要结局
未报告次要终点