The Effect of Lullaby and Classic Music to Prematures During Orogastric Tub Feeding on the Baby's Cerebral Oxygenization, Vital Findings and Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Body temperature (°C)
研究概览
简要总结
In the study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels.
详细描述
In the literature, there are many studies on prematurity pain and its relief. Although the vital signs and comfort levels of infants were examined in many applications for infants hospitalized in the neonatal intensive care unit, no study was found in which the cerebral oxygenation levels of infants were evaluated by NIRS by listening to lullabies and classical music to premature infants. There is no study in the literature examining cerebral oxygenation, vital signs and comfort parameters together during orogastric tube feeding, which is frequently used in preterm infants. For this reason, in this study, lullabies and classical music played to preterm babies during orogastric tube feeding; It will be tried to determine the effect on cerebral oxygenation level, vital signs and comfort levels. It is thought that the study will present new data to the literature and will lead many researches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being at 28-34 weeks of gestation,
- •Stability (in terms of cerebral oxygenation, pain and vital signs) during enrollment,
- •Not having any additional diagnosis other than the diagnosis of prematurity,
- •Indication of bolus feeding with an orogastric tube,
排除标准
- •Congenital anomaly in the baby
- •Diagnosed hearing impairment in the baby
- •Having a history of an invasive procedure (such as a surgical operation) that will disrupt the baby's long-term comfort and cause pain
- •The baby is receiving oxygen therapy or the baby is on mechanical ventilation
- •Any history of disease affecting cerebral oxygenation (such as intraventricular hemorrhage, neonatal convulsions).
结局指标
主要结局
Body temperature (°C)
时间窗: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's body temperature (°C) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Heart rate (minute)
时间窗: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as heart rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
COMFORTneo Scale
时间窗: First measurement - one minute before the baby is fed
The scale is a Likert type scale developed to determine the pain, distress, sedation and comfort needs of newborns followed in the intensive care unit. Ambuel et al. created the Comfort Scale in 1992 to evaluate the distress of children receiving mechanical ventilator support in pediatric intensive care units. Van Dijk et al. revised the scale in 2009 and made the validity and reliability of the COMFORTneo scale only to measure newborn behavior without vital parameters. The Turkish validity and reliability of the scale was performed by Kahraman et al. in 2014. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6, and the highest score is 30. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Newborn Information Form
时间窗: First measurement - Before intervention
This form was developed by the researcher using the literature (Loewy et al 2013, Caparros-Gonzalez et al 2018, Azarmnejad et al 2015, Alipour et al 2013). The form was composed of questions including introductory information about the baby, gestational age, postnatal age, gender, birth weight (gr), weight on the day of the intervention, type of delivery, 1st and 5th min apgar score.
Oxygen saturation (%SpO2)
时间窗: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as Oxygen saturation (%SpO2) were recorded.. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Regional brain oxygen saturation (rSO2) levels
时间窗: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's rSO2 levels were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
Respiratory rate (min)
时间窗: First measurement - one minute before the baby is fed
The form prepared by the researcher; It was prepared in such a way that physiological parameters such as baby's respiratory rate (min) were recorded. The form is designed to record twice, 1 minute before the baby is fed and immediately after the feeding is completed.
次要结局
- Regional brain oxygen saturation (rSO2) levels(Second measurement - immediately after feeding)
- Heart rate (minute)(Second measurement - immediately after feeding)
- Body temperature (°C)(Second measurement - immediately after feeding)
- Oxygen saturation (%SpO2)(Second measurement - immediately after feeding)
- Respiratory rate (min)(Second measurement - immediately after feeding)
- COMFORTneo Scale(Second measurement - immediately after feeding)
研究者
Sibel Küçükoğlu
Assoch Prof
Selcuk University