Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The level of perception of pain in DOC patients
研究概览
简要总结
The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version.
详细描述
The assessment and early diagnosis of pain is of great importance for pain management and treatment in patients with disorders of consciousness. The Nociception Coma Scale (- Revised) is only applicable to assess pain of DOC patients in international clinical setting. The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version. To test internal reliability and inter-rater reliability, both rater A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability, rater A assessed all patients repeatedly on day 2. 'Faces, Legs, Activity, Cry, Consolability' (FLACC) was used to analysis concurrent validity by rater A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years old;
- •no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
- •the presence of periods of eye opening (indicating wakefulness and rest cycles);
- •a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.
排除标准
- •documented history of prior brain injury;
- •psychiatric or neurologic illness;
- •neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
- •no documented history of a prior coma, critical illness or unstable medical condition;
- •upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores <1).
研究组 & 干预措施
vegetative state
patients with vegetative state lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.
干预措施: Nociception Coma Scale (NCS) (Diagnostic Test)
minimally conscious state
Patients with minimally conscious state display inconsistent, but reproducible and discernible signs of awareness using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.
干预措施: Nociception Coma Scale (NCS) (Diagnostic Test)
结局指标
主要结局
The level of perception of pain in DOC patients
时间窗: Within 2 days
This original NCS consists of four subscales to assess motor, verbal, visual and facial behavioral responses and each subscale score ranges from 0 to 3
次要结局
未报告次要终点
研究者
Jing Wang
Dr
Hangzhou Normal University