The Effect of Skin-to-Skin Contact Based on Clinical Guidelines

NCT06514352 | Completed

• 1 other identifier: 3304skincontact
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Newborn health indicators are important data that provide information about the welfare level of countries. Health professionals and relevant institutions have important responsibilities in protecting, developing and ensuring the continuity of newborn health. Health professionals use evidence-based practices revealed by scientific studies in their care approaches. Care and follow-up immediately after birth are very important. When the investigators look at the neonatal mortality rate in our country in 2019, it is shown as 5.3 per thousand and 5 per thousand in 2020. Therefore, neonatal-specific programs and practices need to be strengthened in order to reduce both neonatal and postneonatal death rates. Midwives are the professional group that is with both the mother and the newborn during the birth and postpartum period, can initiate breastfeeding in the early period, and ensure optimal continuation of breastfeeding. It is very important that the basic health indicators of the newborn improve and that the mother and newborn are monitored at certain standards during and after birth. These monitoring must be done according to the criteria. Genç et al. in 2022 to initiate and maintain skin-to-skin contact with the newborn during the postpartum period. (2023) skin-to-skin contact will be made between the mother and the newborn in accordance with the "Skin-to-Skin Contact and Kangaroo Care Clinical Practice Guide".

Conditions

Breastfeeding; Newborn

Keywords

skin to contact; breastfeeding; newborn

Outcome Measures

Primary Outcomes (4)

• Question Form for Socio-Demographic Characteristics Introduction and Skin Contact and Breastfeeding Process

  The form prepared by the researchers consists of 22 questions regarding the socio-demographic characteristics of the mothers and their spouses, the obstetric characteristics of the mothers and the newborn.

  immediately before intervention

• Skin Contact and Breastfeeding Process Follow-up Form

  The form was created by researchers. This is the form in which information about the time when mothers start to apply skin-to-skin contact, the duration of skin-to-skin contact, the time to start breastfeeding, the duration of breastfeeding and the time for the baby to settle on the breast will be recorded.

  immediately after the intervention

• LATCH Breastfeeding Diagnostic Measurement Tool

  During the postpartum period, the breastfeeding status of mothers in the intervention and control groups will be evaluated using the LATCH scale. LATCH Breastfeeding Diagnostic Measurement Tool was developed in 1986 by observing breastfeeding by healthcare professionals or researchers in the clinic; It is an assessment tool that is quick and easy to apply and was created to detect problems that may occur in breastfeeding. Scoring is between 0-2 and the maximum score that can be obtained is 10. In the measurement tool that does not have a cut-off point, a high score indicates that breastfeeding is successful. The reliability study was conducted by Adams and Hewell in 1997. The Turkish reliability study of the scale was conducted by Yenal and Okumuş (2003) and the Chronbach alpha value was found to be 0.95.

  immediately after the intervention, 12 hours after birth, 24 hour after birth

• Newborn Stress Scale

  Newborn Stress Scale: The Newborn Stress Scale, developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature babies, is suitable for use in term babies. The scale items were collected in 8 subgroups in a 3-point Likert type, including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases. Cronbach's alpha coefficient has been reported to be between 0.65-0.81

  immediately after the intervention, 12 hours after birth, 24 hour after birth

Study Arms (4)

skin-to-skin contact group immediately after birth

EXPERIMENTAL

The newborn is placed face to face on the mother's abdomen or chest in the first minute after birth. If medically necessary, suctioning can be done while on the mother's abdomen or chest and the baby is dried thoroughly. To prevent heat loss, the baby's back is covered with a pre-warmed blanket and a hat is placed on his head. All other interventions with the newborn can be postponed until at least the end of the first hour after birth or the first successful breastfeeding.

Other: Skin contact immediately after birth

very early skin contact group

EXPERIMENTAL

In the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, the newborn is placed face down on the mother's bare chest, naked with or without a hat. The newborn's back can be covered with a blanket.

Other: Very Early Skin contact

early skin contact group

EXPERIMENTAL

It can start any time between the first hour and 24 hours after birth. The baby is naked (with or without a diaper) and placed face down on the mother's bare chest between the breasts. The mother can wear a blouse or shirt that opens at the front, or a hospital gown that can be tied at the back. The baby is placed inside the apron so that only the head is exposed. What the mother wears, how the baby is kept warm, and what is placed on the baby's back may vary. The most important thing is that the mother and baby are in direct skin-to-skin contact and the baby is kept dry and warm.

Other: Early Skin contact

control group

NO INTERVENTION

No treatment will be performed on the mothers and newborns in the control group, and the hospital's routine practices (birthing support, newborn and maternal care) will be carried out.

Interventions

Skin contact immediately after birth OTHER

In the immediate skin-to-skin contact group after birth, if the newborn does not need any intervention, he will be placed on the mother's chest immediately (without cord clamping) and skin-to-skin contact will begin. An average of 60 minutes of skin contact will be made until the first breastfeeding occurs. All routine practices for the newborn in the delivery room (except weight measurement) will be performed on the mother's chest. (n=48)

skin-to-skin contact group immediately after birth

Very Early Skin contact OTHER

In the very early skin-to-skin contact group, skin-to-skin contact will begin within the first 30-40 minutes after birth, after the first and emergency intervention is given to the newborn in need of intervention, and skin-to-skin contact will be carried out for an average of 60 minutes until the first breastfeeding occurs.(n=48)

very early skin contact group

Early Skin contact OTHER

For newborns who need intervention after birth and whose skin-to-skin contact cannot be started in the delivery room, skin-to-skin contact will begin within the first 24 hours after birth, after the newborn becomes stable.(n=48)

early skin contact group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Giving birth vaginally
• Primiparous pregnant
• Giving birth at 37 weeks or more
• Single and alive fetus
• Not being pregnant at risk
• Not being an individual with special needs
• Ability to communicate with the pregnant woman
• Stay in the neonatal intensive care unit for less than 24 hours

You may not qualify if:

• Having multiple pregnancies,
• Women who gave up participating in the study

Sponsors & Collaborators

• Gaziantep Islam Science and Technology University: lead

Study Sites (1)

Tarsus University

Toroslar, Mersin, 33000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Emine Serap Çağan, Dr.

  Ağrı Ibrahim Çeçen University

  STUDY CHAIR

• Eda Akbaş, Midwife

  Tarsus public hospital

  PRINCIPAL INVESTIGATOR

• tuğçe sönmez, Dr.

  Tarsus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 23, 2024
• Study Start: December 30, 2024
• Primary Completion: February 15, 2026
• Study Completion: April 8, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-02

Locations

TU (1)