The Impact of a Receptive Music Therapy Intervention on Physiologic Measures, Pain and Agitation of Mechanically Ventilated Patients in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in respiratory rate
研究概览
简要总结
The purpose of this study is to determine whether Music Therapy has an effect on pain, agitation, and vital signs of patients in the Intensive Care Unit (ICU) when compared to usual care. Music Therapy is an intervention provided to patients after a referral by a nurse or attending physician. Patients will be assigned to two groups. The intervention group will receive 1 30 minute music therapy intervention provided by a Board Certified Music Therapist (MT-BC). The music therapy intervention will consist of a relaxation experience with live music presented by the MT-BC on an acoustic guitar, and include improvised music and/or structured songs, created as an ongoing musical experience in response to the immediate needs of the patient. Vital signs, pain, and agitation are collected pre and post. Patients assigned to the control group will receive usual care for a patient in the ICU. Vital signs, pain, and agitation will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients are assigned to either the intervention or control group based on flipping a coin.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or greater
- •On a Mechanical Ventilator
排除标准
- •Airborne and Special Contact Isolation
- •Non English or Spanish Speaking LARs
- •Prisoners
- •Brain Dead
- •Unstable bradycardia or hypotension
- •Patients who have been referred to music therapy with a goal of stimulation.
结局指标
主要结局
Change in respiratory rate
时间窗: 30 minutes
Physiologic Intervention
Change in Oxygenation
时间窗: 30 minutes
Physiologic Intervention
Change in heart rate
时间窗: 30 minutes
Physiologic Intervention
次要结局
- Critical Care Pain Observation Tool (CPOT): Range of 0-8 Includes 2 points for: Facial expression, body movements, muscle tension, compliance with the ventilator/vocalization. Intent is decrease in pain level.(30 minutes)
- RASS: The Richmond Agitation and Sedation Scale (RASS) 0 (Alert and Calm) -1 -5: Drowsy/Unarousable +1-+4 Agitated/Combative Intent is decrease in agitation level(30 minutes)