Musical Intervention on Stress Effects in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- levels of serum cortisol
研究概览
简要总结
Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.
详细描述
Design, Setting and Study Subjects: A randomized clinical trial will be conducted in the ICU of a spanish tertiary hospital. The study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention.
Variables: The main variable will be total serum cortisol, prolactin, interleukin-6 levels. Secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention.
Data collection: There will be 2 groups: intervention and control. The sample will be randomized as patients are admitted. First, they will be receiving the corresponding daily care. The first group of patients will receive the corresponding daily care. The patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. All the variables will be collected before starting the study, during the study and at the end of the study.
Data analysis: A descriptive analysis of each variable will be performed. Subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. If statistically significant, post-hoc tests will be performed using Dunn's test.Dunn's test. Statistical significance will be accepted when p ≤ 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •Admitted to the ICU for a minimum of 24 hours
- •Intubated patients undergoing invasive mechanical ventilation
- •Arterial catheter carriers / central venous catheter
- •Sedation level: BIS: 40 - 60
- •No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale
- •Not having previously undergone any other musical intervention.
排除标准
- •Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.)
- •Severe psychiatric illness
- •Suspected or confirmed drug or alcohol overdose/intoxication/abstinence
- •Hearing impairment
- •Skull lesions that preclude the use of headphones
- •Patients with limitation of therapeutic effort or death expected within 24 hours
- •Brain death diagnosis
- •Failure to obtain informed consent from the legal representative within 72 hours of presentation
- •Refusal of the responsible physician.
结局指标
主要结局
levels of serum cortisol
时间窗: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
µg/dL
levels of interleukin 6
时间窗: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
pg/mL
levels of prolactin
时间窗: Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.
ng/mL
次要结局
- Blood Pressure(Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.)
- Heart rate(Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.)
- Bispectral Index (BIS)(Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.)
- Respiratory rate(Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.)
- Oxygen Saturation(Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.)
研究者
Alba Maestro Gonzalez
Principal Investigator
University of Oviedo