Investigation of the Effects of Early Skin-to-Skin Contact on Mother and Baby in Cesarean Births
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Stress levels and sucking success of newborns
研究概览
简要总结
The rate of cesarean birth continues to increase in the world and in our country. As with all surgeries, the risks of cesarean birth include the possibility of bleeding and infection, prolonged recovery time after birth, delays in initiating breastfeeding and skin-to-skin contact (SSC), and increased likelihood of complications in future pregnancies.
While many hospitals apply SSC after normal births, it is known that the number of hospitals that apply SSC in the operating room after cesarean birth is very few. Factors that prevent the initiation of SSC after cesarean birth include the effect of the current operating room culture, the physiological evaluation process of the baby after birth, the presence of procedures such as measuring body weight, aspiration, and Apgar score evaluation.
Since the mother and baby are separated after cesarean birth, the mother's initiation of breastfeeding in the first hour of life may be delayed, and the duration of exclusive breastfeeding may be shortened. The 90-minute uninterrupted skin-to-skin contact during which the baby is dried and placed directly on the mother's bare chest after birth maximizes the chance that babies are physically ready to breastfeed.
Although there are studies showing the benefits of SSC application in the operating room such as breastfeeding rates, maintaining the body temperature of the newborn, reducing maternal stress levels, and increasing oxytocin levels, a limited number of studies have been reached in the literature using SSC application guidelines developed to ensure the sustainability of SSC application in the operating room, post-op care unit, and obstetrics clinic. The first contribution of this planned study to the literature will be to standardize SSC application with SSC checklists prepared for use in the cesarean operation room, post-op care unit, and obstetrics ward based on SSC application guidelines. As a second contribution, considering the conditions of the health institution where the study will be conducted, the effects of starting SSC as early as possible and applying it in the cesarean operation room, post-op care unit, and obstetrics ward on the stress level of newborns, sucking success, and pain and salivary cortisol (stress) levels of mothers will be evaluated.
详细描述
The main purpose of the proposed study is to evaluate the effect of SSC initiated in different units of the hospital after cesarean delivery with spinal anesthesia on the stress level of newborns, sucking success, pain and salivary cortisol (stress) levels of mothers and physiological parameters of mothers and babies.
The secondary purpose of the study is to evaluate the satisfaction levels of mothers regarding the SSC application initiated in different units of the hospital after cesarean delivery.
Hypotheses of the Study H1: Early initiated SSC is more effective than late initiated SSC in reducing the pain level of mothers after cesarean deliveries.
H2: Early initiated SSC is more effective than late initiated SSC in reducing the salivary cortisol level of mothers after cesarean deliveries.
H3: Early initiated SSC is more effective than late initiated SSC in reducing the stress level of newborns after cesarean deliveries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planning a cesarean section with spinal anesthesia
- •Being between the ages of 18-45
- •Having a singleton pregnancy
- •Being between the gestational age of 37-40 weeks
- •Not having any known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
- •Agreeing to participate in the study
- •Having stable general conditions and vital signs before the skin-to-skin contact procedure
- •Residing in Kütahya
- •Newborns (0-28 days)
- •Having a gestational age between 37-40 weeks
- •Having a birth weight between 2500-4500 grams
- •Apgar score ≥ 7 per minute
- •No health problems, anomalies or congenital diseases
- •No conditions that prevent sucking such as frenulum (tongue tie) or palate problems
排除标准
- •Caesarean births performed with general anesthesia
- •Normal births
研究组 & 干预措施
SSC Group 1 (Operation room)
Skin-to-skin contact (SSC) will be initiated in the operation room, will continue in the post-op care room, while SSC continues, the mother and baby will be transferred to the ward room, and SSC will be continued in the ward room.
干预措施: SSC Group 1 (Operation room) (Other)
SSC Group 2 (Post-operation room)
Skin-to-skin contact (SSC) will be initiated in the post-operative care unit, SSC will not be uninterrupted, SSC will be continued in the ward room.
干预措施: SSC Group 2 (Post-operation room) (Other)
结局指标
主要结局
Stress levels and sucking success of newborns
时间窗: From birth to the first 24 hours of life
Newborn Stress Scale The scale items are grouped into eight subgroups using a three-point Likert scale, including facial expression, skin color, respiration, activity level, soothability, muscle tone, extremities, and posture. Each subgroup is scored on a scale of 0-2 points, with a minimum score of 0 and a maximum score of 16. As the score increases, the infant's stress level increases.
Pain and salivary cortisol (stress) levels of mothers
时间窗: From before transfer to the operation room until 1 hour after transfer to the ward room after birth.
The level of pain experienced by mothers will be assessed using a Visual Analog Scale (VAS). VAS is frequently used to measure subjective parameters. VAS is a 10 cm ruler where "0" represents "no pain" and '10' represents "very severe pain." The patient is instructed to mark the appropriate point on the line corresponding to the intensity of their pain. The distance from the lowest VAS level to the patient's mark is measured with a ruler in centimeters (cm) or millimeters (mm) to obtain the numerical value of the patient's pain intensity. Pain also causes stress. Saliva samples, a noninvasive biomarker, will be collected to determine the stress levels of mothers.
次要结局
- Satisfaction levels o mothers regarding SSC application after cesarean delivery with spinal anesthesia(From the first SSC application until 24 hours after birth)