Department of Communication and Psychology, Aalborg University, Aalborg, Denmark.
Neonatal Department, Meir Medical Center, Kfar-Saba, IsraelTel-Aviv University, Tel-Aviv, Israel.
J Music Ther. 2020 May 2;57(2):219-242. doi: 10.1093/jmt/thaa002.
Music therapy (MT) interventions and skin-to-skin care (SSC) both aim to address the varied needs of preterm infants, including sensory regulation and stress reduction, inclusion of parents in their infant's care, support of parents' emotional state, and enhancing the parent-infant attachment process. Few studies have investigated the combination of both modalities through randomized controlled trials. Evidence of longer-term effects is missing. This article presents a study protocol that will investigate the effects of combined family-centered MT intervention and SSC on preterm-infants' autonomic nervous system (ANS) stability, parental anxiety levels, and parent-infant attachment quality. 12 clusters with a total of 72 preterm infants, with their parents, will be randomized to one of two conditions: MT combined with SSC or SSC alone. Each parent-infant dyad will participate in 3 sessions (2 in the hospital and a 3-month follow-up). The primary outcome of preterm infants' ANS stability will be measured by the high frequency power of their heart rate variability. Secondary outcomes will be physiological measures and behavioral states in infants and anxiety and attachment levels of parents. This trial will provide important, evidence-based knowledge on the use of the "First Sounds: Rhythm, Breath, and Lullaby" model of MT in neonatal care, through an intervention that is in line with the Newborn Individualized Developmental Care and Assessment Program model for supportive developmental care of preterm infants and their parents. Ethical approval (no. 0283-15) was granted from the local Institutional Review Board in April 2017. This trial is registered in ClinicalTrials.gov, NCT03023267.
音乐治疗（MT）干预和皮肤接触护理（SSC）都旨在满足早产儿的各种需求，包括感官调节和减轻压力、让父母参与婴儿护理、支持父母的情绪状态以及增强亲子依恋过程。很少有研究通过随机对照试验调查这两种方式的结合。缺乏对长期效果的证据。本文介绍了一项研究方案，该方案将调查以家庭为中心的综合 MT 干预和 SSC 对早产儿自主神经系统（ANS）稳定性、父母焦虑水平和亲子依恋质量的影响。共有 12 个包含 72 名早产儿及其父母的集群将被随机分为两种条件之一：MT 联合 SSC 或 SSC 单独治疗。每个母婴对将参加 3 次治疗（2 次在医院，1 次 3 个月的随访）。早产儿 ANS 稳定性的主要结果将通过其心率变异性的高频功率来衡量。次要结果将是婴儿的生理测量和行为状态以及父母的焦虑和依恋水平。该试验将通过符合新生儿个体化发育护理和评估方案模型的干预措施，为在新生儿护理中使用“First Sounds：Rhythm，Breath，and Lullaby”MT 模型提供重要的、基于证据的知识，为早产儿及其父母提供支持性发育护理。该试验已于 2017 年 4 月获得当地机构审查委员会的伦理批准（编号 0283-15）。该试验在 ClinicalTrials.gov 注册，编号为 NCT03023267。
