The Effectiveness of Parental Reading Picture-book Intervention on Cardiopulmonary Stability, Hospitalization Anxiety and Parent-Child Attachment Relationship With Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Cardiopulmonary stability
研究概览
简要总结
This study investigates the effects of a parent-child picture book reading intervention on the cardiopulmonary stability of preterm infants, parental anxiety, and parent-child attachment. A randomized controlled trial will be conducted in a neonatal intensive care unit (NICU) and neonatal intermediate care unit in northern Taiwan. A total of 88 preterm infants and their parents will be randomly assigned to an intervention or control group. Parents in the intervention group will read picture books to their infants from a corrected gestational age of 28 weeks to 36 weeks and 6 days. Physiological data (heart rate, respiratory rate, oxygen saturation, and heart rate variability) and parental anxiety levels will be assessed at multiple time points. The study aims to determine whether this intervention improves infant stability, reduces parental anxiety, and enhances parent-child attachment, contributing to improved neonatal care practices.
详细描述
Background The birth and survival rates of preterm infants in our country have significantly improved. However, due to the immaturity of their autonomic nervous systems, preterm infants are at risk of complications stemming from unstable vital signs. This instability often induces anxiety in parents, which can further impact their psychological adjustment and hinder the establishment of a secure parent-child attachment. Consequently, this study aims to develop a systematic intervention program using picture book reading to improve the cardiopulmonary stability of preterm infants, alleviate parental anxiety, and enhance the parent-child bond.
Objective To evaluate the effects of a parent-child picture book reading intervention on the cardiopulmonary stability of preterm infants, parental anxiety during hospitalization, and the parent-child attachment relationship.
Methods This study will employ a randomized controlled trial (RCT) design. Participants will include preterm infants and at least one parent from the neonatal intensive care unit (NICU) and neonatal intermediate care unit of a medical center in northern Taiwan. A total of 88 pairs of preterm infants and their parents will be recruited and randomly assigned to either the experimental or control group. The intervention consists of parents reading picture books to their preterm infants, starting at a corrected gestational age of 28 weeks and continuing until 36 weeks and 6 days. Data will be collected at multiple time points, including measurements of heart rate, respiratory rate, oxygen saturation, and heart rate variability. Subjective data will be gathered using the State-Trait Anxiety Inventory (STAI) and the Parent-Child Attachment Scale, while objective data will be recorded via physiological monitors and heart rate variability analyzers. Statistical analyses, including independent samples t-tests, repeated measures ANOVA, and generalized estimating equations (GEE), will be performed to compare the intervention's effectiveness.
Project Goal To develop and evaluate the effectiveness of a parent-child picture book reading intervention program for preterm infants. The findings aim to inform pediatric clinical care practices and support the health and well-being of families with preterm infants.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm Infants:
- •Born between 28+0 and 36+6 weeks of gestation.
- •Transferred out of the incubator as per medical advice.
- •Passed the newborn hearing screening in both ears.
- •Parents of Preterm Infants:
- •Able to read and comprehend Chinese-language materials.
- •Capable of communicating in Mandarin.
排除标准
- •Preterm Infants:
- •Presence of external ear abnormalities.
- •Receiving sedatives, hypnotics, or caffeine therapy.
- •Parents of Preterm Infants:
- •Having auditory or speech impairments.
研究组 & 干预措施
Preterm Infant Stability, Parental Anxiety, Parent-Child Attachment
干预措施: Parental Reading Picture-book (Behavioral)
Routine Care
The control group in this study will receive standard routine care in the neonatal ward and intensive care unit of a medical center in Northern Taiwan. Routine clinical care involves one parent visiting the preterm infant during visiting hours. After the physician or nurse explains the infant's current condition to the parent, the parent is allowed to visit the preterm infant freely for half an hour. On the day of discharge, control group participants will receive the same educational booklet titled "Reading Picture Books from Scratch" as the experimental group. The benefits and importance of picture book reading interventions will be explained to them, and parents will be encouraged to use the gifted picture books for reading activities at home.
结局指标
主要结局
Cardiopulmonary stability
时间窗: ecorded at 14:00, 14:10, and 14:20 on the second to fourth days after incubator transfer, as well as at 14:20 on the fifth day.
The intervention period in this study begins on the second day after the preterm infant is transferred out of the incubator and concludes on the fifth day. Data collection occurs at 24 time points throughout the study. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and heart rate variability, are recorded at 14:00, 14:10, and 14:20 on the second to fourth days after incubator transfer, as well as at 14:20 on the fifth day.
次要结局
- Hospitalization anxiety(After confirming the assigned group, and research Day 5)
- parent-to-infant attachment(After group assignment is confirmed ,and the fifth day of the study.)
