Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in Oral Feeding Performance
研究概览
简要总结
This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants.
Hypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not.
Hypothesis 2 (H2): Preterm infants who listen to their mother's voice throughout the full oral feeding process have lower heart rates than those who do not.
Hypothesis 3 (H3): Preterm infants exposed to maternal voice throughout the full oral feeding process have lower respiratory rates than those who are not exposed.
Hypothesis 4 (H4): Preterm infants exposed to maternal voice throughout the full oral feeding process have better feeding maturation than those who are not exposed.
Hypothesis 5 (H5): The percentage of nutrient intake in preterm infants exposed to maternal voice throughout the entire oral feeding process is higher than in those not exposed.
Hypothesis 6 (H6): The feeding time of preterm infants exposed to the mother's voice throughout the entire oral feeding process is shorter than that of those not exposed.
Hypothesis 7 (H7): The amount of food consumed per minute by preterm infants exposed to the mother's voice throughout the entire oral feeding process is greater than that of those not exposed.
详细描述
Oral feeding is one of the critical milestones in the growth and development of preterm infants. A delay in achieving successful oral feeding skills may lead to prolonged hospitalization, negatively impact mother-infant bonding, result in long-term feeding difficulties, impair growth and development, and cause adverse neurodevelopmental outcomes. The literature reports that various methods have been used to enhance oral feeding performance, one of which is maternal voice. It has been reported that the maternal voice has a positive effect on the oral feeding performance of preterm infants. Continuing maternal vocal stimulation during the postnatal period (such as singing lullabies, reading books, or engaging in everyday speech) contributes to strengthening synaptic connections in the auditory cortex, increasing the brain's sensory processing capacity, reducing the infant's stress levels, and maintaining physiological stability. The maternal voice positively influences oral feeding performance by helping infants maintain an alert state and facilitating the coordination of sucking, swallowing, and breathing. In this regard, the maternal voice can be used as an evidence-based nursing intervention to enrich the care of preterm infants. However, the number of high-level evidence studies investigating the relationship between maternal voice and oral feeding performance is limited in the literature, and some existing studies report inconclusive results. Therefore, addressing this issue will help fill a gap in the literature.
In this study, preterm infants in the experimental group will listen to a lullaby recorded in their own mother's voice before and during oral feeding, twice daily (morning and evening) for five consecutive days. A Bluetooth-enabled, speaker-equipped voice recorder will be used for each infant individually. No auditory intervention will be applied to the infants in the control group. In both groups, physiological indicators and oral feeding performance will be measured on specific days.
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants born at gestational age ≥28 weeks and ≤34 weeks
- •Infants who are ≥30 postmenstrual weeks old at the time of enrollment
- •Infants weighing ≥1000 grams at the time of enrollment
- •Mothers aged 18 years or older
- •Preterm infants who have passed the hearing screening test
- •Infants whose mothers can provide an average of at least 30 ml of expressed breast milk daily during the study period.
- •Mothers who are Turkish speakers.
- •Infants for whom the decision to transition from enteral feeding to full oral feeding has been made for the first time jointly by the physician and nurse
排除标准
- •Preterm infants with congenital anomalies.
- •Infants with a family history of congenital hearing loss.
- •Infants diagnosed with intraventricular hemorrhage (grade 3-4) or -periventricular leukomalacia.
- •Infants who have had necrotizing enterocolitis requiring treatment.
- •Infants whose mothers have a history of substance abuse or alcoholism
研究组 & 干预措施
Standard feeding group
This group will not be exposed to maternal voice before or during feeding; standard feeding care will be provided.
干预措施: Control Group (standard feeding ) (Other)
Maternal voice group
The maternal voice will be played twice daily, starting 20 minutes before the morning and evening oral feedings and continuing throughout the feeding session.
干预措施: Maternal voice (Procedure)
结局指标
主要结局
Change in Oral Feeding Performance
时间窗: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Oral feeding performance will be measured using the 'Oral Feeding Maturation Monitoring Device.' One of the device's sensors is positioned under the infant's chin, and the other is placed on the chest. The device evaluates the infant's sucking-swallowing-breathing coordination during a 2-minute feeding session.
Change in Oral Feeding Skills
时间窗: The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.
Change in oral feeding skills will be assessed using the Early Feeding Skills Assessment Scale. The scale was originally developed in 2005, and its Turkish validity and reliability were established in 2021. It consists of 5 subdimensions and a total of 19 items. Each item is rated on a scale from 1 to 3. The total score ranges from 19 to 57, with higher scores indicating more advanced feeding skills.
Change in oxygen saturation
时间窗: Oxygen saturation will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and oxygen saturation will be monitored.
Change in heart rate
时间窗: Heart rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and heart rate will be monitored.
Change in respiratory rate
时间窗: Respiratory rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.
Preterm infant will be monitored and respiratory rate will be monitored.
次要结局
未报告次要终点
研究者
Semra Küçük
Research Assistant
Acibadem University