NCT07547579

Brief Summary

This study was conducted using a pre-test-post-test randomized controlled experimental design to investigate the effects of neonatal care education given to primiparous mothers in the last trimester on their self-efficacy perception, prenatal and maternal bonding in the early postpartum period. The study population consisted of pregnant women in the last trimester who applied to the Antenatal School of Kars Harakani State Hospital between November 2024 and November 2026. The study sample consisted of a total of 76 pregnant women, divided into an intervention group (n: 38) and a control group (n: 38). Data were collected using the "Personal Information Form", "General Self-Efficacy Scale", "Prenatal Attachment Inventory", and "Maternal Attachment Scale". The intervention group received training on newborn care. In the first phase of the study, a pre-test was administered to both the intervention and control groups. Following the pre-test, Newborn Care Training was conducted face-to-face with pregnant women in the experimental group in two 20-minute sessions, totaling 40 minutes, after which the pregnant women were given an educational booklet. After this training session, reinforcement training was conducted twice by telephone at one-week intervals, and their questions were answered. After the pre-test, at 36 weeks of gestation, both the intervention and control groups were contacted by telephone and the "General Self-Efficacy Scale" and "Prenatal Attachment Inventory" were administered as post-tests. Six weeks after delivery, the maternal attachment scale was administered to both the intervention and control groups.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress56%
Apr 2024Dec 2027

Study Start

First participant enrolled

April 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

January 2, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

PREGNANCY, NEWBORN, PRENATAL, MATERNAL, SELF-EFFICACY

Outcome Measures

Primary Outcomes (1)

  • General Self-Efficacy

    Changes in maternal self-efficacy levels measured using the General Self-Efficacy Scale during the early postpartum period.

    (between 24 and 41 weeks of pregnancy)

Secondary Outcomes (2)

  • Prenatal Attachment

    (between 24 and 41 weeks of pregnancy)

  • Maternal Attachment

    6th week after birth

Study Arms (2)

Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group

ACTIVE COMPARATOR

Primiparous women in their third trimester assigned to the intervention group will receive a structured newborn care education program in addition to completing the study questionnaires.

Behavioral: Newborn Care Education

Control Group

NO INTERVENTION

Primiparous women assigned to the control group will receive routine prenatal care and will complete the study questionnaires only.

Interventions

The newborn care education program includes information on breastfeeding, infant hygiene, umbilical cord care, infant safety, and basic newborn care practices. The education is provided during the third trimester of pregnancy. Allocation / Randomization Allocation: Randomized Randomization Description: Participants will be randomly assigned to the intervention group or the control group using a computer-generated randomization sequence with a 1:1 allocation ratio. Masking (Blinding) Masking: None (Open Label) Masking Description (opsiyonel): This is an open-label study. Participants and investigators are aware of group assignment.

Intervention Group Intervention Type: Behavioral Name: Newborn Care Education Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study includes pregnant women; therefore, women were included in the study groups.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being over 18 and under 35 years of age, Being in the last trimester of pregnancy (28-32 weeks of gestation) Having no communication barriers and being literate Single pregnancy Spontaneous conception Having applied to the Kars Harakani State Hospital Pregnancy School Agreeing to participate in the study

You may not qualify if:

  • Chronic illness, High-risk pregnancy, Having a psychological disorder, Having applied to a Pregnancy School other than Harakani State Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafkas Üniversitesi

Kars, Merkez, 36100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
this an open-label study. Due to the nature of the educational intervention, neither the participants nor the investigators are blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to an intervention group and a control group. The intervention group will receive the behavioral/educational interventional in addition to completing questionnaires, while the control group will complete questionnaires only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 2, 2026

First Posted

April 23, 2026

Study Start

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The privacy of personal data is respected in this study. Voluntary informed consent forms are obtained from participants. Therefore, the researcher does not share the participants' information.

Locations