The Effect of Simulated Intrauterine Sound Applied to Preterms on Heart Rate, Oxygen Saturation and Comfort Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peripheral oxygen saturation level
研究概览
简要总结
Preterm infants lack intrauterine sounds suitable for their development as they are born early. In addition, they are exposed to many unfamiliar sounds for weeks or months in the neonatal intensive care unit (NICU) where their follow-up and care are continued. , one of evidences is that the maternal voices have an effect on the physiological, neurobehavioral and autonomic functions of the preterm infants. Also, the fact that the maternal voice is a non-pharmacological and non-invasive application has importance for the preterm infant. Therefore, considering the optimal well-being of the infant, it is predicted that using the applications that simulate the extrauterine environment of the preterm infant to the intrauterine environment would decrease the stress behaviors of the infants and would provide the physiological values to be followed up in the positive direction, and as a result of these, it would contribute to supporting the recovery and shortening the discharge period. The study was planned as a randomized controlled experimental design in order to determine the effect of the sound applied on the 26-37 week-old preterm infants on their heart rate, oxygen saturation and comfort level.
详细描述
Preterm infants lack intrauterine sounds suitable for their development as they are born early. In addition, they are exposed to many unfamiliar sounds for weeks or months in the neonatal intensive care unit (NICU) where their follow-up and care are continued. It is known that the preterm infants hear the sounds from the extrauterine and respond to these sounds after the 26th gestational week. The types of the sounds and the level of the noise in the NICU is quite different from the uterus environment. The ambient noise composed of the ventilators, monitors, pagers and alarms of NICU take place of the low-frequency maternal voices in the amniotic environment. For this reason, the preterm infants lack the normal audial stimulants and they are disturbed by the sounds in the NICU environment. As a result, the development of the auditory and language skills and the socio-emotional development of the infants may get harmed. The recent evidences have suggested that the auditory learning and voice recognition experiences of the infants are based on their prenatal experiences. Therefore, it is quite important to make the preterm infants listen to their mothers' voice and the heart rate sound which they are lack of due to their preterm birth and therefore keeping them away from the sounds of the NICU environment.
In the light of this information, one of evidences is that the maternal voices have an effect on the physiological, neurobehavioral and autonomic functions of the preterm infants. Also, the fact that the maternal voice is a non-pharmacological and non-invasive application has importance for the preterm infant. Therefore, considering the optimal well-being of the infant, it is predicted that using the applications that simulate the extrauterine environment of the preterm infant to the intrauterine environment would decrease the stress behaviors of the infants and would provide the physiological values to be followed up in the positive direction, and as a result of these, it would contribute to supporting the recovery and shortening the discharge period.
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
- Single (Participant)
入排标准
- 年龄范围
- 26 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being at -26-36,6 GW,
- •In the first week after birth,
- •Absence of a congenital anomaly,
- •Not being sedated,
- •If the baby has been given eye drops, 4-6 hours have passed,
- •20-30 minutes have passed since the last painful attempt
排除标准
- •Below 26 GW or above 37 GW,
- •Absence in the first week after birth,
- •Having a congenital anomaly,
- •Being sedated,
- •The baby is receiving phototherapy
结局指标
主要结局
Peripheral oxygen saturation level
时间窗: 1 minutes
The peripheral oxygen saturation level of the infants will measured as monitorized.
Newborn Comfort Behavior Scale (COMFORTneo)
时间窗: 5 minutes
The comfort scale (CS) is a scale developed by Ambuel et al., (1992) in order to assess the distress of the children taking the mechanic ventilation support and followed up in the pediatric intensive care unit. The scale was revised by Van Dijk et al. (2009) and developed only for assessing behaviors in the newborns without the physiological parameters. While the lowest score to be obtained from the scale is 6, the highest score is 30. A high score indicates that the infant does not feel comfortable and needs interventions to provide comfort and also 4-6 points indicate moderate pain and distress and 7-10 points indicate severe pain and distress. Kahraman et al., (2014) conducted the Turkish validity and reliability study of the scale with the infants of 24-42 GW.
Heart rate
时间窗: 1 minutes
The heart rate of the infants will measured as monitorized.
Noise level
时间窗: 1 minutes
Noise measurement will be made with noise meter from the outside of the incubator during the hours when the study would be conducted.
Sound level
时间窗: 1 minutes
In order for the baby to hear the sound created in the incubator; Before each procedure, a noise measuring device was placed in the incubator and the level of sound heard by the baby in the incubator was recorded as dBA. Then the Mp3 device is set to the appropriate volume.
次要结局
未报告次要终点
研究者
Birsen Mutlu
Associate Professor
Istanbul University - Cerrahpasa (IUC)