Validity and Reliability Study of the Pain Indicator Behavior Scale Adapted to Measure Pain in Critically Ill Patients With Acquired Brain Damage, Non-communicative and With an Artificial Airway (ESCID-DC).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To assess the construct validity and the reliability
研究概览
简要总结
A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.
详细描述
Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation.
The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre.
Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age equal to or greater than 18 years.
- •Inability to communicate verbally or motor.
- •Have a artificial airway.
- •Informed consent of the family member or representative of the patient.
排除标准
- •Previous pathology of cognitive impairment.
- •Previous brain injury.
- •Previous psychiatric disorder.
- •Previous dementia.
- •Previous chronic substance abuse.
- •Previous chronic diabetics.
- •Previous spinal cord injury.
- •Previous severe polyneuropathy (diagnosed or suspected).
- •Confirmed diagnosis of brain death.
- •Continuous infusion of muscle relaxants and / or barbiturate coma.
- •Level of deep sedation (RASS -5).
结局指标
主要结局
To assess the construct validity and the reliability
时间窗: 30 months
Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
次要结局
- To analyze the scale under different levels of consciousness(30 months)
- To assess pain from different procedures with ESCID-DC scale(30 months)
- To assess pain from different procedures with NCS-R scale(30 months)
- To analyze the scale under different etiology of brain damage(30 months)
- To analyze the scale under different degrees of sedation(30 months)
研究者
Candelas Lopez Lopez
RN, MSc, PhD
Hospital Universitario 12 de Octubre