The Effect of Music and Essential Oil on Agitation in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Agitation score
研究概览
简要总结
The study aims to assess the effect of using music and essential oil on agitation in mechanically ventilated patients. Listening to classical relaxation music, and inhalation to bergamot oil will be used in this study.
详细描述
Agitation in critically ill patients is a phenomenon that can compromise patient safety and assistance during intensive care unit (ICU) hospitalizations. This trial will be conducted in five general intensive care unit. One hundred and twenty patients will be enrolled in this study divided into three equal groups (40 patients in each group). Group A is the control group. Group B is music group. Group C is essential oil group. Agitated mechanically ventilated patients will be randomly assigned to one of the three groups. Each group will be subjected to its specific intervention and they will be monitored for seven days. Agitation score and frequency outcome will be assessed at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
Computer generated randomization (www.randomizer.org) will be used to randomly assign patients to groups. Information of allocation was available to the principal researcher only. Patients will be assigned in sequential numbers that will be placed in an opaque, sealed envelope by the researcher. After patients enrollment, the envelope will be opened. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the patients was blinded.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agitation with RASS score +2 or more
- •Mechanical ventilation
- •Patients with GCS 13-15
排除标准
- •Psychiatric illness
- •Cognitive disorders
- •Neurological disorder
- •Hearing deficit
- •Smelling deficit
- •Respiratory asthma
- •Allergic rhinitis
结局指标
主要结局
Agitation score
时间窗: 7 days
Agitation score is assessed by Richmond Agitation-Sedation Scale (RASS). The RASS is a 10-point scale ranging from -5 to +4. Levels from -1 to -5 denote increasing levels of sedation. Levels from +1 to +4 describe increasing levels of agitation. Zero score is the best response for the patient which is considered normal.
次要结局
未报告次要终点