THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Newborn Stress Evaluation Form (NSEF)
研究概览
简要总结
The study was planned in a randomized controlled manner in order to evaluate the effect of mother's voice and lullaby on stress and sleep-wake situations of premature babies.
详细描述
Objective
This randomized controlled study was carried out to evaluate the effect of mother's voice and lullaby on preterm infants' stress and sleeping-waking states.
Study design:The study was carried out in a newborn unit in a public hospital in Turkey. In this study, 90 preterm newborn were divided into three groups equally as mother's voice (n=30), lullaby (n=30) and control groups (n=30). Data were obtained by Mother and Newborn Identification Form, Newborn Stress Evaluation Form (NSEF) and Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF). On the 1st, 3rd and 5th days of the study; Newborns' NSEF and NSWEF scores at pre-, post-study and on the fifth minutes were evaluated. Data were evaluated by using descriptive statistics, homogeneity tests, chi-square, intra-class correlation coefficent, two way of analysis on repeated measures, generalized linear model, pearson correlation analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Video footage in the study was made by three experts. Experts blindly evaluated the groups to which the videos they evaluated belonged to.
入排标准
- 年龄范围
- 32 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •32 0/6 -36 6 weeks of gestation
- •Not connected to respiratory support device
- •No surgical intervention
- •Not receiving medical treatment other than appropriate vitamin supplements and antibiotic treatments
- •Does not have a congenital or acquired malformation related to hearing,
- •Can tolerate enterally given food (no NEC, digestive system and chromosomal abnormalities)
- •The mother is at least a primary school graduate
- •Diabetic mother without a baby • SGA and no IUGR
排除标准
- •Premature babies who do not meet the inclusion criteria.
结局指标
主要结局
Newborn Stress Evaluation Form (NSEF)
时间窗: NSEF was measured on days 1 through 5, which had a 5-day application period.
NSEF, there is no stress indicator '0', mild stress indicators' 1 ', moderate stress indicators' 2', and severe stress indicators'. It is scored as 3.
次要结局
- Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)(NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.)
研究者
Dilek Deri̇nce Eryuruk
Principal Investigator
TC Erciyes University