NCT07656207

Brief Summary

To determine the effects of skin-to-skin contact at birth on birth outcomes (placental delivery time, postpartum pain level, time of first breastfeeding, and breastfeeding motivation) and on postpartum parenting behavior.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

March 5, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 18, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 5, 2026

Last Update Submit

June 14, 2026

Conditions

Keywords

Skin to skinpainbreastfeedingparenthoodmidwifery

Outcome Measures

Primary Outcomes (5)

  • Personal Information Form

    The form prepared by the researchers consists of 14 questions about the mothers' socio-demographic characteristics, obstetric characteristics, and newborns.

    baseline

  • Breastfeeding Motivation Scale

    The Breastfeeding Motivation Scale, based on Self-Determination Theory, was developed by Peleg et al. (2015). It was adapted into Turkish by Şahin et al. in 2017, and a validity and reliability study was conducted. Exploratory factor analysis revealed that the Turkish version consists of 23 items and five sub-factors for primiparous mothers, and 24 items and six sub-factors for multiparous mothers. According to the calculated Cronbach's alpha value, the Breastfeeding Motivation Scale is a highly reliable scale for both primiparous (Cronbach's alpha: 0.887) and multiparous (Cronbach's alpha: 0.914) mothers. The scale consists of 24 items and 5 sub-dimensions. The items are rated on a 4-point Likert scale, with each item receiving a score between 1 and 4. The total score of the scale is calculated by averaging the scores of the sub-dimensions. As the score obtained from a subscale increases, it is interpreted as an increase in the motivation represented by that subscale.

    Periprocedural

  • VAS

    The VAS (Visual Assessment Scale) is one of the most commonly used measurement tools for determining pain intensity. The VAS consists of a line drawn on a horizontal or vertical axis, 10 cm or 100 mm long. At one end of this line is the word "no pain," and at the other end is the word "unbearable pain." The distance from the lowest VAS value to the point marked by the pregnant woman is measured in cm or mm to determine the numerical value of the pain intensity. The evaluation is based on these markings. The VAS is considered a successful measurement tool for evaluating the effectiveness of pain relief methods (Demir, 2012; Carvalho \& Cohen, 2013).

    Periprocedural

  • Postnatal Parenting Behavior Scale

    The scale was developed by Britton et al. in 2001 to evaluate the behaviors exhibited by parents during their first interactions after birth (Britton et al., 2001). The Turkish adaptation, validity, and reliability study of the scale was conducted by Çalışır et al. (2009) (Çalışır et al., 2009). This scale aims to evaluate the parenting behaviors of the mother or father during their first encounter with their baby immediately after birth through observation. In the six-item scale, the observer records whether the parent exhibits each behavior; behaviors performed are indicated with a "+" sign, and those not performed with a "-" sign. A score of "1" is given for each observed behavior, and a score of "0" for each unobserved behavior. Thus, the total score that can be obtained from the scale ranges from 0 to 6. A high score indicates that the parent exhibits more positive and supportive parenting behaviors towards their baby.

    Periprocedural

  • Skin-to-Skin Contact, Placental Separation, and Breastfeeding Process Tracking Form

    This form was created by researchers. It is used to record information about when mothers started skin-to-skin contact, the duration of skin-to-skin contact, the time they started breastfeeding, the duration of breastfeeding, and the time it took for placental separation.

    Periprocedural

Study Arms (2)

Control group

NO INTERVENTION

Mothers and newborns in the control group will not receive any procedures; they will undergo the hospital's routine procedures.

Immediate Skin-to-Skin Contact After Birth (intervention group)

EXPERIMENTAL

Immediate skin-to-skin contact after birth: If the newborn requires no intervention, they will be immediately placed on the mother's chest (before cord clamping) and skin-to-skin contact will begin. Skin-to-skin contact will be maintained for approximately 60 minutes until the first breastfeeding occurs. All routine procedures performed in the delivery room for the newborn (except for weight measurement) will be performed while the newborn is on the mother's chest.

Other: Immediate skin-to-skin contact after birth (intervention group)

Interventions

Immediate skin-to-skin contact after birth: If the newborn requires no intervention, they will be immediately placed on the mother's chest (before cord clamping) and skin-to-skin contact will begin. Skin-to-skin contact will be maintained for approximately 60 minutes until the first breastfeeding occurs. All routine procedures performed in the delivery room for the newborn (except for weight measurement) will be performed while the newborn is on the mother's chest.

Immediate Skin-to-Skin Contact After Birth (intervention group)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vaginal delivery
  • Primiparous pregnancy
  • Delivery at 37 weeks or later
  • Single, live fetus
  • Not a high-risk pregnancy
  • Not an individual with special needs
  • Able to communicate

You may not qualify if:

  • Women who Have a multiple pregnancy,
  • Develop complications requiring emergency intervention in the mother or baby after delivery,
  • Have their baby admitted to the neonatal intensive care unit after delivery,
  • Have a cesarean section,
  • Withdraw from the study will be excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Toroslar, Mersin, 33000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainBreast Feeding

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Serap Ejder Apay, Prof.

    Ataturk University

    STUDY CHAIR
  • Mehtap Begüm Orak, Master's student

    Ataturk University

    STUDY CHAIR

Central Study Contacts

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
Assistant Professor

Study Record Dates

First Submitted

March 5, 2026

First Posted

June 18, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 18, 2026

Record last verified: 2026-03

Locations