The Use of Music for Neonates Post-Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy
研究概览
简要总结
The purpose of this study is to explore the feasibility of implementing nurse-led music therapy in a cohort of neonates admitted to the Cardiac Intensive Care Unit (CICU) post congenital heart surgery. In the proposed setting, the use of a standardized nurse-led music therapy protocol for post-operative neonates would build upon current successful nurse-led efforts to wean sedatives and opioid use for patients admitted to the CICU. The investigators believe data generated from this exploratory feasibility study may serve to further inform a larger study involving the use of music therapy in the cardiac intensive care.
详细描述
A predetermined recording of a music playlist meeting the properties of sedative music is being developed in consultation with a Boston Children's Hospital (BCH) music therapist. Properties of sedative music include soothing, stable, constant, and relatively unchanging, slow tempo and light rhythmic emphasis, constant volume and rhythm, lullaby style, repetitious and no separate melody for chorus/bridge. The music recorded for the neonates has been produced specifically for this study. In accordance with the recommendations for soothing music, BCH Music Therapists have recorded English nursery rhymes (Figure 1) in the key of C major at 60bpm with acoustic guitar and voice. The playlist will be stored on an Apple iPod Touch and will be delivered through a Bluetooth speaker that is positioned centrally (so that the sound input is received binaurally) at the subjects head or feet for a period of 20 minutes once during a 12-hour shift for 14 days or until mechanical ventilation has been discontinued, whichever is first.
The literature supports a duration of up to 30 minutes of music therapy followed by at least 30 minutes of silence, with a maximum of four hours per day. Music played for longer than 30 minutes has the potential to be a source of over-stimulation/agitation. There is some evidence to suggest that playing music for long periods of time (two four-hour segments) has a negative effect. In addition, it seems reasonable and likely to assume that the neonate could have a period of 30 minutes when they will not require an intervention associated with post-operative care. The protocol will target a 20 minute playlist. This will allow for variation in the length of songs while ensuring that music will not be played for longer than 30 minutes. There will be at least 30 minutes of quiet between music therapy session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 37 weeks gestation,
- •Between 0 to 30 days of age
- •24 hours post congenital heart surgery
- •Receiving mechanical ventilation
- •Background noise level (at bedside) at the time of music therapy must be 55dB or less.
排除标准
- •Hemodynamically unstable or end of life
- •If patient is in a closed Giraffe bed
- •Evidence of hearing impairment
- •Patient has known or suspected active seizure disorder
结局指标
主要结局
Feasibility of initiating music therapy protocol: Proportion of shifts with music therapy
时间窗: 14 days or when mechanical ventilation is discontinued, whichever comes first
Proportion of shifts with music therapy using the number of shifts during music therapy was initiated by number of eligible shifts
Feasibility of implementing 20-minute music therapy protocol: Proportion of shifts that the subject received the full 20- minute therapy uninterrupted
时间窗: 14 days or when mechanical ventilation is discontinued, whichever comes first
Proportion of shifts that the subject received the full 20- minute therapy uninterrupted using the number of shifts receiving the full therapy by the number of eligible therapy sessions
次要结局
- Physiological Measure - State Behavioral Scale(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Parent Satisfaction: survey(24 hours following completion of music therapy)
- Physiological Measure - Oxygen Saturation(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Physiological Measure - Blood Pressure(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Physiological Measure - Face, Legs, Activity, Cry, Consolability (FLACC) scale.(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Music Frequency(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Bedside nurse perception of music therapy(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Physiological Measure - Heart Rate(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
- Measuring sedation(Baseline and 5, 10, 20, 30, and 60 minutes from start of music therapy)
研究者
Jean Connor
Director of Nursing Research, Cardiovascular and Critical Care Services
Boston Children's Hospital