Skin to Skin ContactNCT06956859
The Effect of Paternal Skin-to-Skin Contact on Neonatal Parameters
A study testing Paternal Skin to skin applicated to newborns in people with Skin to Skin Contact and Newborn; Vitality, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of skin-to-skin contact between the babies of mothers who gave birth by cesarean section and their fathers on the physiological parameters and comfort of the newborn. Read more about this study
- Who is it for?
- Ages 5 to 15 minutesHealthy volunteers can take part
- Conditions the study is for
- Skin to Skin Contact, Newborn; Vitality
- What is being tested?
- Paternal Skin to skin applicated to newborns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 15 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being born at term (38-42 weeks of gestation)
- Birth weight between 2500-4000gr
- 1st and 5th minute apgar score of 7 and above
- The newborn does not have any health problems
- No surgical intervention
- No communication problems,
- At least primary school graduate,
- over 18 years old,
Who cannot join
- Neonatal exclusion criteria
- Congenital anomalies
- Metabolic diseases
- Severe periventricular/intraventricular bleeding
- History of minor or major surgery
- Babies from single-parent families
Show all 12Show fewer
- Babies with intubation and mechanical ventilation
- Having a birth weight of less than 2500 g and more than 4000 g.
- Unwillingness to participate in the study
- Any contagious disease that can be transmitted through skin contact
- Experiencing fatherhood for the first time
- Not having any contagious disease that can be transmitted through skin contact
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Adapazarı, Sakarya
About this study
Official title: The Effect of Paternal Skin-to-Skin Contact on Neonatal Physiological Parameters, Comfort and Cortisol Level
This study was planned to examine the effect of skin-to-skin contact between the babies of mothers who gave birth by cesarean section and their fathers on the physiological parameters and comfort of the newborn. The research, which is in a randomized controlled experimental design, will be carried out at the Ministry of Health Sakarya University Training and Research Hospital.
The spouses and babies of 80 pregnant women who were hospitalized with a planned cesarean delivery in Sakarya Training and Research Hospital Gynecology and Child Additional Service Building, will be divided into intervention and control groups by simple randomization method.
Read more
Paternal skin-to-skin contact will be applied to newborns in the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort Behavior Scale will be applied to the cases included in the study, body temperature, oxygen saturation, heart rate, respiration will be evaluated, and salivary cortisol analysis will be performed.
The discussion and results of the study will be written in the accompaniment of the findings.
Read the detailed description
Skin-to-skin contact (TTT) was developed in 1978 in Bogota, Colombia to meet the shortage of incubators required for the care of low-birth-weight babies. It is a method of placement. The sense that occurs in the first seconds after birth in healthy newborns is the sense of touch. Developed countries attach importance to studies that will reveal the effectiveness of this method in order to initiate the parent-newborn relationship and to provide developmental care of the newborn. focused on physiological measures of adaptation to the new environment, such as The results of the study revealed that TTT has many beneficial physiological effects such as increased deep sleep, stable thermoregulation, increased heart rate, respiratory rate and oxygen saturation in newborns. In addition, early skin contact contributes to the development of the nervous system, fewer medical problems, early discharge and reduction in infection rates. Birth is a condition that requires the baby to leave the safe and warm environment in the mother's womb and adapt to a completely foreign environment. It is considered as trauma for the newborn because of its Trauma causes increased stress. Stress negatively affects the evolutionary behavior of newborns and can create intermediate chemicals and hormones in the body that will disrupt the development of the baby. In addition to the immediate negative effects, it can last for the rest of their lives.One of the methods of investigating the degree of stress is to measure the body's cortisol levels; however, it should be noted that stress is not the only cause of the secretion of cortisol into the bloodstream, and other factors such as nutrition, sleep, and sensory simulation can also affect its level. It is known as ". In this case, it can be said that the early postpartum period is critical time to reduce stress. During cesarean section with general / spinal - epidural anesthesia in the operating room, mothers are placed in a supine position, intravenous fluid support is provided, and they are monitored and monitored. Procedures routinely performed on newborn baby after cesarean section; Blood is taken from the umbilical cord of the newborn for the hemogram and blood group, after waiting for 1 minute, the cord is cut and dried and placed under the radiant heater in the operating room. The 1st and 5th minute Apgar scores are evaluated by a midwife who has received NRP training, the choanal and rectal patency is checked, and a mother-baby wristband is put on. The newborn is wrapped in pre-heated operating room covers, and after being shown to the mother for 1-2 minutes, anthropometric measurements (height, body weight, head circumference) are made, vitamin K, hepatitis B vaccine is administered, and the baby is taken to the baby room in the delivery room for the first examination of the baby by the neonatology specialist. . The transfer of the newborn from the delivery room to the room in the gynecology service is provided in approximately 30-50 minutes.
After cesarean births, mother-baby meeting takes place later. This situation negatively affects the comfort of the newborn. Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping individuals related to their needs, obtaining peace and coping with problems". It is often used in babies. The extrauterine environment is an environment where noisy, cool, bright, dry heat and light patterns are not sufficient for newborn babies, unlike intrauterine life, where the baby has difficulty in making movements with the power of gravity. It is said that the practice of TTT with the father during the period until the postpartum routine care of the mother is completed can reduce the problems that the newborn may experience in the early period, provide comfort, and facilitate the adaptation of the father to the new parenting role. It has been determined that they are shorter, they are calmer, and the duration of restlessness is shortened.
- Conditions
- Skin to Skin Contact, Newborn; Vitality
- Being tested
- Paternal Skin to skin applicated to newborns
- Keywords
- Skin to skin contact, cortisol, Comfort, newborn, paternalty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paternal Skin to skin applicated to newbornsBehavioural
Paternal Skin to skin applicated to newbornsin the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort
| Study group | Role | What they receive |
|---|---|---|
| Skin to skin | Experimental | Paternal skin to skin applied to newborns. Receives: Behavioral: Paternal Skin to skin applicated to newborns |
| Control Group | No intervention | Routine maintenance practices were performed in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
newborn salivary cortisol level
measurement of cortisol in saliva via the cotizol kit
Measured: 0th minute,20th minute,45th minute
newborn oxygen saturation
measurement newborn saturation via pulseoxymeter
Measured: 0th minute,20th minute,45th minute
newborn body temperature
measurement newborn body temperature by thermometer
Measured: 0th minute,20th minute,45th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start15 May 2022
- Primary completion15 Sep 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin to Skin ContactStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956859
- Sponsor's protocol ID
- SaglikBilimleri
- Status last verified
- May 2025
- First submitted
- 23 Jun 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005 Nov;116(5):1105-13. doi: 10.1542/peds.2004-2440.
PubMed 16263996Davis EP, Sandman CA. The timing of prenatal exposure to maternal cortisol and psychosocial stress is associated with human infant cognitive development. Child Dev. 2010 Jan-Feb;81(1):131-48. doi: 10.1111/j.1467-8624.2009.01385.x.
PubMed 20331658Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
PubMed 22201156Takahashi Y, Tamakoshi K, Matsushima M, Kawabe T. Comparison of salivary cortisol, heart rate, and oxygen saturation between early skin-to-skin contact with different initiation and duration times in healthy, full-term infants. Early Hum Dev. 2011 Mar;87(3):151-7. doi: 10.1016/j.earlhumdev.2010.11.012. Epub 2011 Jan 8.
PubMed 21220191
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paternal Skin-to-Skin Contact on Neonatal Physiological Parameters, Comfort and Cortisol Level
- ClinicalTrials.gov ID
- NCT06956859
- Acronym / sponsor ID
- SaglikBilimleri
- Conditions
- Skin to Skin Contact, Newborn; Vitality
- Keywords
- Skin to skin contact, cortisol, Comfort, newborn, paternalty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 4 May 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.
This study was planned to examine the effect of skin-to-skin contact between the babies of mothers who gave birth by cesarean section and their fathers on the physiological parameters and comfort of the newborn. The research, which is in a randomized controlled experimental design, will be carried out at the Ministry of Health Sakarya University Training and Research Hospital.
The spouses and babies of 80 pregnant women who were hospitalized with a planned cesarean delivery in Sakarya Training and Research Hospital Gynecology and Child Additional Service Building, will be divided into intervention and control groups by simple randomization method.
Paternal skin-to-skin contact will be applied to newborns in the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort Behavior Scale will be applied to the cases included in the study, body temperature, oxygen saturation, heart rate, respiration will be evaluated, and salivary cortisol analysis will be performed.
The discussion and results of the study will be written in the accompaniment of the findings.
Detailed description
Skin-to-skin contact (TTT) was developed in 1978 in Bogota, Colombia to meet the shortage of incubators required for the care of low-birth-weight babies. It is a method of placement. The sense that occurs in the first seconds after birth in healthy newborns is the sense of touch. Developed countries attach importance to studies that will reveal the effectiveness of this method in order to initiate the parent-newborn relationship and to provide developmental care of the newborn. focused on physiological measures of adaptation to the new environment, such as The results of the study revealed that TTT has many beneficial physiological effects such as increased deep sleep, stable thermoregulation, increased heart rate, respiratory rate and oxygen saturation in newborns. In addition, early skin contact contributes to the development of the nervous system, fewer medical problems, early discharge and reduction in infection rates. Birth is a condition that requires the baby to leave the safe and warm environment in the mother's womb and adapt to a completely foreign environment. It is considered as trauma for the newborn because of its Trauma causes increased stress. Stress negatively affects the evolutionary behavior of newborns and can create intermediate chemicals and hormones in the body that will disrupt the development of the baby. In addition to the immediate negative effects, it can last for the rest of their lives.One of the methods of investigating the degree of stress is to measure the body's cortisol levels; however, it should be noted that stress is not the only cause of the secretion of cortisol into the bloodstream, and other factors such as nutrition, sleep, and sensory simulation can also affect its level. It is known as ". In this case, it can be said that the early postpartum period is critical time to reduce stress. During cesarean section with general / spinal - epidural anesthesia in the operating room, mothers are placed in a supine position, intravenous fluid support is provided, and they are monitored and monitored. Procedures routinely performed on newborn baby after cesarean section; Blood is taken from the umbilical cord of the newborn for the hemogram and blood group, after waiting for 1 minute, the cord is cut and dried and placed under the radiant heater in the operating room. The 1st and 5th minute Apgar scores are evaluated by a midwife who has received NRP training, the choanal and rectal patency is checked, and a mother-baby wristband is put on. The newborn is wrapped in pre-heated operating room covers, and after being shown to the mother for 1-2 minutes, anthropometric measurements (height, body weight, head circumference) are made, vitamin K, hepatitis B vaccine is administered, and the baby is taken to the baby room in the delivery room for the first examination of the baby by the neonatology specialist. . The transfer of the newborn from the delivery room to the room in the gynecology service is provided in approximately 30-50 minutes.
After cesarean births, mother-baby meeting takes place later. This situation negatively affects the comfort of the newborn. Comfort is defined as "an expected result with a complex structure within the physical, psychological, social and environmental integrity of helping individuals related to their needs, obtaining peace and coping with problems". It is often used in babies. The extrauterine environment is an environment where noisy, cool, bright, dry heat and light patterns are not sufficient for newborn babies, unlike intrauterine life, where the baby has difficulty in making movements with the power of gravity. It is said that the practice of TTT with the father during the period until the postpartum routine care of the mother is completed can reduce the problems that the newborn may experience in the early period, provide comfort, and facilitate the adaptation of the father to the new parenting role. It has been determined that they are shorter, they are calmer, and the duration of restlessness is shortened.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin to skin | Experimental | Behavioral: Paternal Skin to skin applicated to newbornsPaternal skin to skin applied to newborns. |
| Control Group | No intervention | –Routine maintenance practices were performed in the control group. |
Who may qualify
- Ages
- 5 to 15 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Being born at term (38-42 weeks of gestation)
- Birth weight between 2500-4000gr
- 1st and 5th minute apgar score of 7 and above
- The newborn does not have any health problems
- No surgical intervention
Key exclusion criteria (12 listed)
- Neonatal exclusion criteria
- Congenital anomalies
- Metabolic diseases
- Severe periventricular/intraventricular bleeding
- History of minor or major surgery
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 |
|---|---|---|
| Paternal Skin to skin applicated to newbornsPaternal Skin to skin applicated to newbornsin the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort | Behavioural | Skin to skin |
Primary outcome
newborn salivary cortisol level
Time frame: 0th minute,20th minute,45th minute
measurement of cortisol in saliva via the cotizol kit
newborn oxygen saturation
Time frame: 0th minute,20th minute,45th minute
measurement newborn saturation via pulseoxymeter
newborn body temperature
Time frame: 0th minute,20th minute,45th minute
measurement newborn body temperature by thermometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 16263996Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005 Nov;116(5):1105-13. doi: 10.1542/peds.2004-2440.
- Results publication: PubMed 20331658Davis EP, Sandman CA. The timing of prenatal exposure to maternal cortisol and psychosocial stress is associated with human infant cognitive development. Child Dev. 2010 Jan-Feb;81(1):131-48. doi: 10.1111/j.1467-8624.2009.01385.x.
- Results publication: PubMed 22201156Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.
- Results publication: PubMed 21220191Takahashi Y, Tamakoshi K, Matsushima M, Kawabe T. Comparison of salivary cortisol, heart rate, and oxygen saturation between early skin-to-skin contact with different initiation and duration times in healthy, full-term infants. Early Hum Dev. 2011 Mar;87(3):151-7. doi: 10.1016/j.earlhumdev.2010.11.012. Epub 2011 Jan 8.
Related trials for Skin to Skin Contact
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Not yet recruiting
Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
Preterm Infants, Orogastric Feeding
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
RecruitingObservational study
Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.
Pregnancy, Cesarean Delivery
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paternal Skin to skin applicated to newborns in people with Skin to Skin Contact and Newborn; Vitality, run by Saglik Bilimleri Universitesi 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 4 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
newborn salivary cortisol level (time frame: 0th minute,20th minute,45th minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956859, which also lists 4 linked publications.
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 4 May 2025.