The Effect of Paternal Skin-to-Skin Contact on Neonatal Parameters

May 1, 2025 updated by: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sakarya
      • Adapazarı, Sakarya, Turkey
        • Sakarya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Inclusion criteria for newborns;

  • 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

Inclusion criteria for fathers

  • No communication problems,
  • At least primary school graduate,
  • over 18 years old,

Exclusion Criteria:

Neonatal exclusion criteria

  • Congenital anomalies
  • Metabolic diseases
  • Severe periventricular/intraventricular bleeding
  • History of minor or major surgery
  • Babies from single-parent families
  • Babies with intubation and mechanical ventilation
  • Having a birth weight of less than 2500 g and more than 4000 g.

Exclusion criteria for fathers

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin to skin
Paternal skin to skin applied to newborns.
Behavioral: Paternal Skin to skin applicated to newborns
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
No Intervention: Control Group
Routine maintenance practices were performed in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
newborn salivary cortisol level
Time Frame: 0th minute,20th minute,45th minute
measurement of cortisol in saliva via the cotizol kit
0th minute,20th minute,45th minute
newborn oxygen saturation
Time Frame: 0th minute,20th minute,45th minute
measurement newborn saturation via pulseoxymeter
0th minute,20th minute,45th minute
newborn body temperature
Time Frame: 0th minute,20th minute,45th minute
measurement newborn body temperature by thermometer
0th minute,20th minute,45th minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SaglikBilimleri

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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