The Effect of Patient-Preferred Music, Relaxation Music, and Standard Care Environment on Patients in Intensive Care Units
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
The purpose of this study is to investigate the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.
详细描述
This study is a prospective randomized clinical trial. The purpose of this 4-stage study is to explore the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.
Stage 1: Recommendation of relaxation music by music therapists who serves as expert panel
Stage 2: Analysis of recommended relaxation music by music therapists
Stage 3: Content validation of relaxation music by healthy adults
Stage 4: Comparison of patients' physiological, psychological, and biological responses to patient-preferred music, relaxation music, and standard care environment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Communicative (non-intubated, non-sedated)
- •At least three days of admission (excluding day of admission)
- •18 years or older
- •Mean arterial blood pressure equal or greater than 65 throughout study
- •Mean SpO2 equal or greater than 90 throughout study
- •Glasgow coma scale equal or greater than 14
- •Bilirubin level less than 5
- •Ammonia level less than 1
- •Hematocrit level greater than 15
- •BUN equal or less than 100
- •Non-communicative (intubated, sedated)
- •At least three days of admission (excluding day of admission)
- •18 years or older
- •Mean arterial blood pressure equal or greater than 65 throughout study
- •Mean SpO2 equal or greater than 90 throughout study
- •Glasgow coma scale equal or greater than 10
- •Bilirubin level less than 5
- •Ammonia level less than 1
- •Hematocrit level greater than 15
- •BUN equal or less than 100
排除标准
- •Communicative (non-intubated, non-sedated)
- •Patients admitted for or less than 3 days
- •Patients with hearing impairments
- •Patients with neurological impairments that might impair their ability to process information
- •Patients on glucocorticoid medications
- •Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
- •Patient's condition altered dramatically over the 3 days of research
- •Non-communicative (intubated, sedated)
- •Patients admitted for or less than 3 days
- •Patients with hearing impairments
- •Patients with neurological impairments that might impair their ability to process information
- •Patients on glucocorticoid medications
- •Patients with mental health diagnoses and currently experiencing active psychosis such as hallucinations and/or delusions
- •Patient's condition altered dramatically over the 3 days of research
研究组 & 干预措施
1
Patient-preferred music
干预措施: Patient-preferred music (Other)
2
Relaxation Music
干预措施: Relaxation Music (Other)
3
Standard of Care
干预措施: Standard Care Environment (Other)
结局指标
主要结局
Anxiety level
时间窗: 4 data points throughout 1-hour intervention
Pain level
时间窗: 4 data points throughout 1-hour intervention
Respiration rate
时间窗: 4 data points throughout 1-hour intervention
Comfort level
时间窗: 4 data points throughout 1-hour intervention
Saliva/Serum Immunoglobulin A Concentration
时间窗: 3 data points throughout 1-hour intervention
Heart rate
时间窗: 4 data points throughout 1-hour intervention
Blood pressure
时间窗: 4 data points throughout 1-hour intervention
Saliva/Serum Cortisol level
时间窗: 3 data points throughout 1-hour intervention
次要结局
- Psychophysical properties of relaxation music(1 rating)
研究者
Charles J. Yowler MD
Professor, Case Western Reserve University School of Medicine
MetroHealth Medical Center