Harp Music: Effects on HRV, Cortisol and Activity

描述（由申请人提供）： 音乐可以促进早产儿的生长，减少早产儿的住院时间;早期接触音乐也可能有长期影响。然而，音乐影响临床结果的途径仍然未知。本研究的目的是通过心率变异性（HRV）和唾液皮质醇（SC）以及活动水平（ACT）来评估竖琴音乐对恢复期早产儿生理和行为的影响。我们假设：a）这些结果将受到竖琴音乐的影响; B）第三次音乐剂量的这种影响将大于第一次音乐剂量;以及c）三个结果（HRV、SC和ACT）将彼此适度相关。受试者将包括90名在我们的中级护理托儿所（ICN）住院的孕龄34 - 37周的婴儿，他们已通过新生儿听力筛查测试，病情稳定，已住院，预计将再住院10天。在基线时，我们将测量HRV、SC和活动两次，间隔45分钟。受试者将被随机分配至对照组（常规治疗）或两种干预措施之一a）安静的房间或B）竖琴音乐。将在同一研究室连续三天每天进行45分钟的干预。 主要结局包括：1）HRV，2）SC和3）ACT的变化。在前人研究的基础上，本文提出了心率变异性分析的五个主要参数，包括：心搏间期的标准差、样本熵、样本不对称性、Hurst参数和功率谱分析的HF/LF比值。 运动将以电子记录在活动计上的每分钟运动量为单位进行测量。统计分析将包括：1）第1天常规护理控制与音乐与安静的主要结局与基线的比较（竖琴音乐第一次给药的效果），2）第1天（第一次给药）与第3天（第3次给药）的主要结局比较，以及3）基线时三个主要结局指标与不同干预措施之间的相关性。二次分析将探索哪些HRV参数对音乐最敏感，以确定哪些参数最适合未来的研究。这项研究为了解音乐与减少噪音对早产儿的生理和行为影响提供了重要的比较数据。未来的研究将评估不同种类、数量、频率和持续时间的音乐对早产儿生理、临床、行为和发育结果的直接和长期影响。

DESCRIPTION (provided by applicant): Music may enhance growth and reduce the length of stay in premature infants; early exposure to music may also have long-term effects. However, the pathways by which music affects clinical outcomes remain unknown. The purpose of this study is to evaluate the effects of harp music on convalescing premature infants physiologically through heart rate variability (HRV) and salivary cortisol (SC) and behaviorally through activity level (ACT). We hypothesize that: a) these outcomes will be affected by harp music; b) such effects will be greater for the third dose of music than the first dose; and c) that the three outcomes (HRV, SC and ACT) will be moderately correlated with each other. Subjects will include 90 infants, between 34 and 37 weeks post-conceptional age, hospitalized at our Intermediate Care Nursery (ICN) who have passed the newborn hearing screening test, are medically stable, have been hospitalized and are expected to remain for 10 more days. At baseline, we will measure HRV, SC and activity twice, separated by 45 minutes. Subjects will be randomized to a control group (usual care) OR one of two interventions a) quiet room or b) harp music. Interventions will be given for 45 minutes daily on three consecutive days in the same study room. Primary outcomes include changes in: 1) HRV, 2) SC and 3) ACT. Based on our previous research, the five primary parameters for HRV analysis include the standard deviation of the interbeat interval, sample entropy, sample asymmetry, Hurst parameter, and the HF/LF ratio of the power spectral analysis. Movement will be measured in movements per minute as recorded electronically on an actimeter. Statistical analysis will include: 1) comparisons with baseline of the primary outcomes for usual care control vs. music vs. quiet on Day 1 (effect of first dose of harp music), 2) comparisons of the primary outcomes on Day 1 (first dose) vs. Day 3 (3rd dose), and 3) correlations between the three primary outcome measures at baseline and with the different interventions. Secondary analysis will explore which of the HRV parameters is most sensitive to music in order to determine which is most suitable for future studies. This study provides crucial comparative data for understanding the physiologic and behavioral effects of music vs. decreased noise on premature infants. Future studies will assess the immediate and long-term impact of different kinds, amounts, frequency and duration of music on physiologic, clinical, behavioral and developmental outcomes in premature infants.