The Effect of Reading Therapy on Newborns
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Determine the change in parasympathetic nervous system response
研究概览
简要总结
The primary purpose of this pilot study is to specifically examine the effect of parental reading on the ANS of mother and neonate in the hospital setting. The investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns.
详细描述
Supporting infant ANS development has been implicated in their improved cardiorespiratory and neuropsychiatric outcome; furthermore, improved parasympathetic activity, a branch of ANS, is a predictor of the mother-infant relationship, and the best marker for caregiving behavior. In Feldman and Eidelman's 2003 study, they demonstrated that mother-infant skin-to-skin contact, also known as Kangaroo Care, accelerates ANS maturation in pre-term infants, which is critical for their recovery. If reading is shown to have a positive effect on mother infant ANS, hospitals will be able to incorporate this into practice as a feasible alternative for when Kangaroo Care isn't possible. The investigators hope to learn if these reading interventions will help to mitigate distress symptoms, among both mother and baby, within the hospital. The investigators will examine the association of reading therapy with the infant's crying patterns, length of stay in the hospital, weight gain, and behavior compared to before the reading was done.
Seeing that Scala's findings from 2018 is the only indication of physiologic benefits of reading to infants in the hospital, additional research is required in this particular area. The testing and application of reading therapy in the Neonatal Intensive Care Unit (NICU) would improve a high-stress environment for both parents and infants. Data collected from this project will not only add some much-needed information to the limited knowledge of the physiological effects of reading on neonates, but also demonstrate how infant outcomes can be improved in a cost-effective, efficient manner within the hospital setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted to the Tulane-Lakeside Hospital Newborn Nursery
- •Corrected gestational age 34 weeks or older
- •No identified hearing disorder
- •Do not have a diagnosed developmental disability (i.e. Down Syndrome)
- •Do not have Fetal Alcohol Syndrome
- •Medically cleared to participate in the study
- •Biological mother able/willing to give consent in English & complete surveys.
排除标准
- •Corrected gestational age < 34 weeks old
- •Has an identified or potential hearing disorder (i.e, failed hearing screen)
- •Has diagnosed developmental disability (i.e. Down syndrome)
- •Has Fetal Alcohol Syndrome
- •Is not medically cleared to participate in the study
- •Biological mother unable/unwilling to give consent.
研究组 & 干预措施
Patient arm
The subject population will be newborn infants admitted to the Newborn Nursery (NN) at Tulane Lakeside Hospital. The investigators are anticipating some mothers can be recruited from the prenatal clinics who expect to deliver at Tulane Hospital during pregnancy as well.
干预措施: Book reading (Behavioral)
结局指标
主要结局
Determine the change in parasympathetic nervous system response
时间窗: 20 minutes of reading
The change in parasympathetic nervous system response from the reading therapy will be measured using MindWare System, where an increase in parasympathetic nervous system response shows positive physiological outcomes in the newborns and mothers.
Determine the change in vagal tone
时间窗: 20 minutes of reading
The change in vagal tone from the reading therapy will be measured using MindWare System, where an increase in vagal tone shows positive physiological outcomes in the newborns and mothers.
次要结局
未报告次要终点