The Effect of Skin-to-skin Contact Between Mother and Newborn

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin to Skin Contact; Galvanic Skin Response
• Intervention / Treatment: Procedure: Birth Under General Anesthesia; Procedure: Birth Under Spinal Anesthesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Özdemir; Phone Number: +905302859400; Email: dr.ftmozdemir@gmail.com

Study Locations

• Turkey
  • Kayseri, Turkey
    • Erciyes University
    • Contact: Fatma Ozdemir; Phone Number: 05302859400; Email: dr.ftmozdemir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Healthy pregnancy between 37-40 weeks
2. Elective caesarean section
3. Having a singleton pregnancy

Exclusion Criteria:

1. Preterm labour under 37 weeks of gestation
2. Those with known systemic diseases
3. Those with known fetal anomalies
4. Pregnant women who will give birth normally
5. Multiple pregnancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: General Anesthesia; Pregnant women who will have a cesarean section under general anesthesia.	Procedure: Birth Under General Anesthesia; Before anaesthesia, GSR electrodes will be connected and signal recording will be started. After caesarean section, the newborn will be evaluated and GSR signals will be recorded again after the mother wakes up by providing skin-to-skin contact.
Experimental: Spinal Anestesia; Pregnant women who will have a cesarean section under spinal anesthesia.	Procedure: Birth Under Spinal Anesthesia; GSR electrodes will be connected before anaesthesia, and since the mother will be conscious during caesarean section, the newborn will have skin-to-skin contact with the mother immediately after birth. During this process, GSR signals of the mother and the baby will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galvanic Skin Response	Skin To Skin contact of the newborn with the mother affects the Galvanic Skin Response.	Effects of skin-to-skin contact with in 5 minutes after birth

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Newborn; General anesthesia; Skin to skin contact
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2024/224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No