Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
研究概览
简要总结
The aim of this study is to validate the Critical-Care Pain Observation Tool (CPOT) in the setting of the Intensive care unit (ICU). Prior to patient recruitment the tool will be translated by the method of translation-back translation by Greek and English native speakers. The tool will be administered to patients who are admitted into the ICU.
详细描述
The aim of this study is to validate the Critical-Care Pain Observation Tool (CPOT) in the setting of the Intensive care unit (ICU). Prior to patient recruitment the tool will be translated by the method of translation-back translation by Greek and English native speakers. The study is designed as a prospective randomized crossover clinical trial. Patients will be randomly allocated into two study groups. In Group I the CPOT tool is administered prior to a painful stimulus (ITime0), during the painful stimulus (ITime1) and soon afterwards (ITime2).In Group II the CPOT tool is administered prior to a non painful stimulus(IITime0), during a non-painful stimulus (IITime1) and soon afterwards (IITime2). After these trials the patients in the two groups will crossover into the other group and the whole process will be repeated. The painful stimulus is set to be the passive turning of the patient into the bed and the non painful stimulus is the cleaning of the arm or leg. 20 minutes afterwards the CPOT tool is administered once again in both groups in order to obtain the values when there is no stimulus (ITime3). The tool is administered by two trained members of the study team in a blind manner. Both of the observers administer the tool at the same time but one of them is positioned in the ward of the patient and the other one behind a curtain with no contact with the observer but only with the patient and the monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the two observers are aware of the study group and none of the rest of the study team
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 admitted in the ICU
- •Age> 18 years old
- •No hearing or visual deficit
- •No contraindication to body repositioning
排除标准
- •Patients with neurological deficit
- •Patients administered with neuromuscular blocking agents
- •Patients with motor or sensory deficits
结局指标
主要结局
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
时间窗: The CPOT tool (Critical Care Pain Observation Tool)is administered 1 minute after a painful stimulus (IITime2) which is set to be the patient's blood pressure measurement
Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of \>2:There is a medium to severe level of pain.
次要结局
- Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values(The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus)
- Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values(The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus)
- Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values(The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus)
- Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values(The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus)
研究者
Georgia Micha
Principal Investigator, Anaesthesiologist, MD, MSc, PhD
Saint Savvas Anticancer Hospital