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

NCT ID: NCT06827522

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-05-01

Brief Summary

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.

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.

Conditions

Galvanic Skin Response; Skin to Skin Contact

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

General Anesthesia

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

Group Type: EXPERIMENTAL

Birth Under General Anesthesia

Intervention Type: PROCEDURE

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.

Spinal Anestesia

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

Group Type: EXPERIMENTAL

Birth Under Spinal Anesthesia

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ozdemir

Principal Investigator, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University

Kayseri, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Fatma Özdemir

Role: CONTACT

dr.ftmozdemir@gmail.com

+905302859400

Facility Contacts

Fatma Ozdemir

Role: primary

dr.ftmozdemir@gmail.com

05302859400

Other Identifiers

2024/224

Identifier Type: -

Identifier Source: org_study_id