The Effect of Amniotic Fluid Odor on Postnatal Adaptation and Stress in Healthy Newborns Born by Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Heart Rate:beats per minute
研究概览
简要总结
This study aims to determine whether exposure to the odor of a newborn's own amniotic fluid affects postnatal adaptation and stress in healthy newborns born by cesarean section. Newborns will be randomly assigned to either an intervention group or a control group. Newborns in the intervention group will be exposed to a sterile material moistened with their own amniotic fluid, while newborns in the control group will be exposed to a sterile material moistened with distilled water. Postnatal adaptation, physiological responses, and stress levels will be evaluated at predetermined time points.
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 (Investigator)
入排标准
- 年龄范围
- 38 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns delivered by cesarean section at 38-42 weeks of gestation
- •Absence of a maternal history of high-risk pregnancy, including eclampsia, preeclampsia, or gestational diabetes
排除标准
- •Birth weight below 2,500 g
- •Birth weight of 4,000 g or above
- •Apgar score below 7 at either 1 or 5 minutes after birth
- •Presence of a congenital anomaly
- •Admission to the neonatal intensive care unit during the early postnatal period
结局指标
主要结局
Heart Rate:beats per minute
时间窗: At 30 minutes after birth
The newborn's heart rate will be measured using a pulse oximeter and recorded as beats per minute. Heart rate values will be compared between the amniotic fluid odor group and the sterile distilled water odor group.
Respiratory Rate: breaths per minute
时间窗: At 30 minutes after birth
The newborn's respiratory rate will be assessed by counting respiratory movements for one minute and recorded as breaths per minute. Respiratory rate values will be compared between the study groups.
Peripheral Oxygen Saturation:percentage
时间窗: At 30 minutes after birth
The newborn's peripheral oxygen saturation will be measured using a pulse oximeter and recorded as a percentage. Oxygen saturation values will be compared between the study groups.
Body Temperature: degrees Celsius
时间窗: At 30 minutes after birth
The newborn's body temperature will be measured using a digital thermometer and recorded in degrees Celsius. Body temperature values will be compared between the study groups.
次要结局
- Neonatal Stress Level(30 minutes after birth)
研究者
Funda Güler
Nurse, PhD
Aydin Adnan Menderes University