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临床试验/NCT03023267
NCT03023267已完成不适用

Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
parasympathetic tone

研究概览

简要总结

The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

详细描述

Premature infants and their parents are prone to high anxiety levels and a risk of experiencing trauma due to the preterm birth and its implications. Facing various emotional physical and neural high-risk factors may lead to continuous stress reactions in both the infant and parents, affecting their well being, the parent-infant relationship and the infant's medical state outcome. Attending to both infants' emotional and physiological needs of stability and comfort, as well as parents' support, can lead to an improvement in the premature infants' medical state and the parent-infant bonding process. Furthermore, reducing stress reaction facilitates perceptual memory and learning in premature infants. Two well established interventions in the neonatal care aiming to address the varied premature-family needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports over the last three decades, regarding each modality, has shown beneficial effects in improvement and stabilization of infants' medical state, inclusion of parents in their infants' treatment and in facilitation of meaningful parent-infant interactions to promoting bonding patterns. However, a major lack of rigorous Randomized control studies presenting the clinical applications of MT techniques and methods in the NICU care exists, as well as only few research have positioned the parents in center of investigation, and/or presented their outcome and perspective. Accordingly, only few research have investigated the combination of MT and KC through an RCT. The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Weeks 至 18 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Preterm infants ≤ 37 weeks' gestation
  • •Clinically stable preterm
  • •Hearing confirmed by distortion product oto- acoustic emissions

排除标准

  • •Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
  • •Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
  • •Parents refusal to participate

研究组 & 干预措施

Interventional

Experimental

Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization

干预措施: Music therapy and Kangaroo care (Behavioral)

Control

Active Comparator

Applying only Kangaroo care to mothers and fathers during their stay in the NICU

干预措施: Kangaroo Care alone (Behavioral)

结局指标

主要结局

parasympathetic tone

时间窗: During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age

The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of \>0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shmuel Arnon

Senior Neonatologist

Meir Medical Center

研究点 (1)

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