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临床试验/NCT06827522
NCT06827522尚未招募不适用

Analysis of the Effect of Skin-to-skin Contact with the Mother on Galvanic Skin Response Signals in Newborns

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Galvanic Skin Response

研究概览

简要总结

A 2016 Cochrane Review shows that skin-to-skin contact promotes breastfeeding and strengthens mother-infant bonding. For the mother, skin-to-skin contact was found to promote early separation of the placenta, reduce postpartum haemorrhage, increase breastfeeding self-efficacy, reduce stress levels and promote oxytocin release. For the infant, it has been revealed that it provides important benefits such as decreased postnatal stress, improved thermoregulation, shortened crying time and increased breastfeeding success.

In line with this information, it is hypothesised that Galvanic Skin Response can be used to objectively evaluate the psychological and mental effects of early skin-to-skin contact on the mother and newborn after birth. The findings of this study will contribute to clinical practice by providing scientific evidence for neonatal care.

详细描述

This study will be carried out using galvanic skin response (GSR) to objectively evaluate the psychological and physiological effects of postnatal skin-to-skin contact on mother and infant. Scientific research shows that early postnatal skin-to-skin contact provides many benefits for both mother and baby. The 2016 Cochrane Review emphasises that skin-to-skin contact promotes breastfeeding and strengthens postnatal attachment. For the mother, skin-to-skin contact was found to promote early separation of the placenta, reduce postpartum haemorrhage, increase breastfeeding self-efficacy, support oxytocin release and reduce stress levels. In terms of the baby, it is seen that it has important benefits such as decreased postnatal stress, improved thermoregulation, shortened crying time and increased breastfeeding success. In the literature, the positive effects of skin-to-skin contact on the baby's body temperature, breastfeeding success and physiological stability have been proven.

This study will be conducted in Erciyes University Faculty of Medicine, Department of Obstetrics and Gynaecology and will be carried out with the participation of 100 volunteer mothers who will give birth by elective caesarean section at 37-40 weeks of gestation. In the study, two different groups, general anaesthesia and spinal anaesthesia, will be examined and the effects of anaesthesia type on skin-to-skin contact will be evaluated. After obtaining informed consent from the volunteer patients included in the study, their records will be created. Those who gave birth before 37 weeks of gestation, those who had normal vaginal delivery, those with known systemic diseases or fetal anomalies will be excluded from the study.

GSR electrodes will be connected to the mothers before anaesthesia and galvanic skin response will be measured during labour. After the baby is born, initial assessments will be made by the neonatal nurse and paediatrician and 1st and 5th minute APGAR scores will be determined. Cord pH value, birth weight and neonatal morbidity rates of the newborn will be recorded. The baby will be brought for skin-to-skin contact with the mother, and GSR signals from both mother and baby will be recorded during this process. Signal analyses will be performed by examining physiological changes during and after skin-to-skin contact with the newborn mother.

GSR signals will be recorded with the BIOPAC device. The measurements will be analysed by methods such as Short-Time Fourier Transform, Power Spectral Density and Wavelet Transform. Detailed analyses will be performed on the time-frequency axis using techniques such as Singular Spectrum Analysis and Empirical Mode Decomposition. In the classification phase, different algorithms such as artificial neural networks, support vector machines, logistic regression and clustering methods will be evaluated. FIR and IIR filtering methods will be applied in the processing of GSR signals to remove noise and interference from the signals.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Healthy pregnancy between 37-40 weeks
  • •Elective caesarean section
  • •Having a singleton pregnancy

排除标准

  • •Preterm labour under 37 weeks of gestation
  • •Those with known systemic diseases
  • •Those with known fetal anomalies
  • •Pregnant women who will give birth normally
  • •Multiple pregnancies

研究组 & 干预措施

General Anesthesia

Experimental

Pregnant women who will have a cesarean section under general anesthesia.

干预措施: Birth Under General Anesthesia (Procedure)

Spinal Anestesia

Experimental

Pregnant women who will have a cesarean section under spinal anesthesia.

干预措施: Birth Under Spinal Anesthesia (Procedure)

结局指标

主要结局

Galvanic Skin Response

时间窗: Effects of skin-to-skin contact with in 5 minutes after birth

Skin To Skin contact of the newborn with the mother affects the Galvanic Skin Response.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Ozdemir

Principal Investigator, Medical Doctor

TC Erciyes University

研究点 (1)

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