跳至主要内容
临床试验/NCT01427894
NCT01427894已完成不适用

The Combined Effects of Maternal Singing During Skin to Skin Contact (Kangaroo Care) in Preterm Infants in the Neonatal Intensive Care Unit Environment.

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年11月1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
30
试验地点
1
主要终点
Reduced Heart Rate

研究概览

简要总结

Study objective is to evaluate the additive effect of maternal singing during skin to skin contact (Kangaroo Care) on anxiety reduction both to infants and their mothers.

详细描述

Maternal singing to preterm infants during Kangaroo Care intervention, is it beneficial?

Protocol

Maternal voice is a predominant source of multimodal stimulation for the developing fetus that is largely lost for the preterm infant amidst the unfiltered levels of auditory stimuli in the neonatal intensive care unit (NICU). These elevated levels of auditory stimulation in the NICU can interfere with an infant's sleep and have a negative effect on vital signs and oxygen saturation. Common sources of sound for the preterm infant are derived from routine incubator noise, monitoring alarms, and the speech sounds of healthcare team, all of which they would not typically encounter if life in the uterus had continued to term. In the midst of these additional sounds, preterm infants lose significant contact with an auditory stimulus they would typically be exposed to until full-term birth (their mothers' voice).

Skin to skin contact care (Kangaroo care) was found to produce cardiorespiratory stability, decrease apneic and periodic breathing, and improve sleep patterns and weight gain in preterm infants. This technique has also been shown to help mothers of preterm infants to develop and strengthen self-confidence and attachment behaviors, leading to reduced stress response. Live music was shown to have a beneficial effect on psychophysiological responses in both mothers and preterm infants during their stay in the NICU.

Aim: To evaluate the combined influence of live maternal singing during kangaroo care (KC) on maternal anxiety and stable preterm infants' responses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
1 Week 至 6 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •clinically stable infants
  • •postmenstrual age <37 weeks
  • •normal hearing confirmed by measurement of distortion product otoacoustic emission (DPOAE).

排除标准

  • •observed hyperresponsiveness to live music
  • •congenital anomaly that mainly affects hearing
  • •medication intake (phenobarbital, furosemide, gentamycin) that might interfere with the reaction to musical stimuli
  • •brain anomalies associated with neurological disorders (grade 3-4 intraventricular hemorrhage, periventricular leukomalacia).
  • •Maternal inclusion criteria
  • •ability to hear
  • •literary ability to read and answer an anxiety questionnaire
  • •Maternal exclusion criteria
  • •signs or medical history of postpartum depression

研究组 & 干预措施

Maternal Singing

Experimental

Maternal singing during Kangaroo Care of stable preterm infants

干预措施: Maternal singing with Kangaroo Care (Other)

Kangaroo Care

No Intervention

Kangaroo Care without singing

结局指标

主要结局

Reduced Heart Rate

时间窗: 30 minutes

Reduced respiratory rate

时间窗: 30 minutes

次要结局

  • Als' Behavioral Score(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验