Galvanic Skin ResponseNCT06827522
The Effect of Skin-to-skin Contact Between Mother and Newborn
A study testing Birth Under General Anesthesia and Birth Under Spinal Anesthesia in people with Galvanic Skin Response and Skin to Skin Contact, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Galvanic Skin Response, Skin to Skin Contact
- What is being tested?
- Birth Under General Anesthesia and Birth Under Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnancy between 37-40 weeks
- Elective caesarean section
- Having a singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes University
Kayseri, Kayseri
Fatma Ozdemir, 05302859400, dr.ftmozdemir@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Birth Under General Anesthesia, Birth Under Spinal Anesthesia
- Keywords
- Spinal anesthesia, General anesthesia, Skin to skin contact, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth Under General AnesthesiaProcedure or surgery
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.
Birth Under Spinal AnesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Experimental | Pregnant women who will have a cesarean section under general anesthesia. Receives: Procedure: Birth Under General Anesthesia |
| Spinal Anestesia | Experimental | Pregnant women who will have a cesarean section under spinal anesthesia. Receives: Procedure: Birth Under Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic Skin Response
Skin To Skin contact of the newborn with the mother affects the Galvanic Skin Response.
Measured: Effects of skin-to-skin contact with in 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Galvanic Skin ResponseStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, 100 volunteers (n=50 general anesthesia, n=50 spinal anaesthesia) will undergo caesarean section, and the choice of anaesthesia will be made with the consent of the patient. The type of anesthesia will evaluate the effects of skin-to-skin contact on the mother and baby.. Prenatal GSR electrodes will be connected and signal recordings will be obtained from mother and baby, and the physiological effects of skin-to-skin contact will be analysed. APGAR score (Activity, pulse, grimace, apperarance, respiration 0-10), cord pH, birth weight and neonatal follow-up data will be recorded. GSR signals will be recorded and filtered with BIOPAC, features will be extracted and time and frequency analyses will be performed. Classification will be performed with artificial neural networks and deep learning. The results will be evaluated with statistical tests and the effect of anaesthesia type and skin-to-skin contact on mother-infant will be investigated.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ozdemir, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827522
- Sponsor's protocol ID
- 2024/224
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Skin-to-skin Contact with the Mother on Galvanic Skin Response Signals in Newborns
- ClinicalTrials.gov ID
- NCT06827522
- Acronym / sponsor ID
- 2024/224
- Conditions
- Galvanic Skin Response, Skin to Skin Contact
- Keywords
- Spinal anesthesia, General anesthesia, Skin to skin contact, Newborn
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the study, 100 volunteers (n=50 general anesthesia, n=50 spinal anaesthesia) will undergo caesarean section, and the choice of anaesthesia will be made with the consent of the patient. The type of anesthesia will evaluate the effects of skin-to-skin contact on the mother and baby.. Prenatal GSR electrodes will be connected and signal recordings will be obtained from mother and baby, and the physiological effects of skin-to-skin contact will be analysed. APGAR score (Activity, pulse, grimace, apperarance, respiration 0-10), cord pH, birth weight and neonatal follow-up data will be recorded. GSR signals will be recorded and filtered with BIOPAC, features will be extracted and time and frequency analyses will be performed. Classification will be performed with artificial neural networks and deep learning. The results will be evaluated with statistical tests and the effect of anaesthesia type and skin-to-skin contact on mother-infant will be investigated.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Experimental | Procedure: Birth Under General AnesthesiaPregnant women who will have a cesarean section under general anesthesia. |
| Spinal Anestesia | Experimental | Procedure: Birth Under Spinal AnesthesiaPregnant women who will have a cesarean section under spinal anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnancy between 37-40 weeks
- Elective caesarean section
- Having a singleton pregnancy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth Under General AnesthesiaBefore 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. | Procedure or surgery | General Anesthesia |
| Birth Under Spinal AnesthesiaGSR 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. | Procedure or surgery | Spinal Anestesia |
Primary outcome
Galvanic Skin Response
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birth Under General Anesthesia and Birth Under Spinal Anesthesia in people with Galvanic Skin Response and Skin to Skin Contact, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Özdemir (+905302859400, dr.ftmozdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Galvanic Skin Response (time frame: Effects of skin-to-skin contact with in 5 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.