The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Comfort
研究概览
简要总结
This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.
详细描述
After obtaining ethical approval for the study, all infants with a gestational age between 30 and 34 weeks in the Neonatal Clinic will be evaluated. After the infants are assigned to groups, the data collection phase will begin.
Before data collection, the researcher will provide necessary information about the study to the families of eligible newborns and answer their questions. Infants whose parents give written consent to participate will be included in the study. Information on the newborn and parent introductory information form will be recorded by the researcher. All procedures will be conducted between 08:00 and 16:00.
**Group 1: Infants Receiving Kangaroo Care (Kangaroo Care + Mother's Voice + Fetal Position Group):** Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour immediately after enteral feeding at least five days a week until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will read a story to the baby. After kangaroo care, infants will be placed in the incubator and positioned in the lateral fetal position for half an hour. During this process, interventions will be minimized unless necessary.
Until full oral feeding is achieved, comfort will be assessed using the Neonatal Comfort Behavior Scale at least five days a week, once daily: before feeding, immediately before ending kangaroo care (at 60 minutes), and 30 minutes after fetal positioning (at 90 minutes).
On the mornings of kangaroo care days, before feeding, the infant's growth will be evaluated: the infant will be weighed naked using a digital baby scale sensitive to ±10 grams; length and head circumference will be measured with a non-stretchable measuring tape and recorded.
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
- 30 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with a gestational age between 30-34 weeks.
- •The mother's ability to read and write.
- •The infant must be fully enterally fed at the time of enrollment in the study.
- •Infants who are being fed via orogastric tube at the time of enrollment.
- •Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.
- •Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.
排除标准
- •Presence of a congenital anomaly or genetic disease.
- •Requirement of ventilator support.
- •Infants receiving antibiotics for sepsis or suspected sepsis.
- •Administration of sedative treatment.
- •Having an intracranial hemorrhage greater than grade II.
- •The mother having a physical condition that prevents skin-to-skin contact.
- •The mother using substances or alcohol.
结局指标
主要结局
Comfort
时间窗: Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.
The scale is a Likert-type tool developed to assess the sedation and comfort needs, as well as pain and distress levels, of newborns monitored in intensive care units. The Numeric Rating Scales are based on the caregiver nurse's observations. Each item on the scale is scored from 1 to 5, and the total score is used for evaluation. The minimum possible score on the Neonatal Comfort Behavior Scale is 6, and the maximum is 30. A total score between 9 and 13 indicates that the infant is comfortable, while a score between 14 and 30 suggests that the infant is experiencing pain or distress, is uncomfortable, and requires comfort-providing interventions.
Transition to Oral Feeding
时间窗: From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.
The time from the infant's inclusion in the study until the transition to full oral feeding will be evaluated.
Comfort
时间窗: Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.
The scale is a Likert-type tool developed to assess the sedation and comfort needs, as well as pain and distress levels, of newborns monitored in intensive care units. The Numeric Rating Scales are based on the caregiver nurse's observations. Each item on the scale is scored from 1 to 5, and the total score is used for evaluation. The minimum possible score on the Neonatal Comfort Behavior Scale is 6, and the maximum is 30. A total score between 9 and 13 indicates that the infant is comfortable, while a score between 14 and 30 suggests that the infant is experiencing pain or distress, is uncomfortable, and requires comfort-providing interventions.
Transition to Oral Feeding
时间窗: From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.
The time from the infant's inclusion in the study until the transition to full oral feeding will be evaluated.
次要结局
- Anthropometric measurements(From the first day of the intervention until the end of the 4-week study period, measurements will be taken at 9:00 a.m. prior to feeding on each day kangaroo care is provided.)
- Anthropometric measurements(From the first day of the intervention until the end of the 4-week study period, measurements will be taken at 9:00 a.m. prior to feeding on each day kangaroo care is provided.)
研究者
Negarin Akbari
Assisstant Professor
Fenerbahce University