NCT06953544

Brief Summary

This study was planned as a randomised controlled trial to examine the effects of a "Father-Sensitive Childbirth Preparation Class" on the level of prenatal attachment. The main question it aims to answer is: 1- How does a father-sensitive birth preparation class affect fathers' prenatal attachment levels? It was conducted between February 1, 2024, and October 1, 2024, with expectant fathers living in Mersin province, whose spouses were experiencing their first pregnancy, who were between 20-32 weeks' gestation, and who were going to become fathers for the first time. A total of 99 expectant fathers were included in the study - 50 in the intervention group and 49 in the control group. The intervention group was given a "Father-Sensitive Childbirth Preparation Training" consisting of four sessions, while the control group received a standard "Childbirth Preparation Training", also consisting of four sessions. The "Descriptive Data Collection Tool" and the "Prenatal Father Attachment Scale" were used to collect the research data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 10, 2025

Last Update Submit

April 23, 2025

Conditions

Keywords

Childbirth Preparation ProgramPaternal attachmentAntenatal attachmentMidwifery

Outcome Measures

Primary Outcomes (1)

  • Paternal Antenatal Attachment Scale (PAAS) total score mean

    It consists of 16 questions in a 5-point Likert format, designed to evaluate the feelings and thoughts of expectant fathers towards the developing baby in the womb, based on their emotions, thoughts, and experiences over the past two weeks. Nine items on the scale are reverse-scored, and the total score ranges from 16 to 80; higher scores indicate a stronger level of antenatal attachment.

    14 days after completing the 12-hour father-sensitive childbirth preparation class

Study Arms (2)

Father-Sensitive Birt Education

EXPERIMENTAL

The father-sensitive birth education group was given "Father-Sensitive Childbirth Preparation Education" consisting of four sessions.

Behavioral: Father-Sensitive Education

Standardized Birt Education

ACTIVE COMPARATOR

The control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions.

Behavioral: Standardized birth education

Interventions

he father-sensitive education program preserves the basic structure of the Childbirth Preparation Education program, but has been enriched with original content that supports the active emotional and functional participation of fathers-to-be in the birth process.

Father-Sensitive Birt Education

The control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions.

Standardized Birt Education

Eligibility Criteria

Age19 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants were:
  • Over 19 years of age,
  • At least literate,
  • Whose spouse was between 20 and 32 weeks pregnant,
  • Whose spouse was primigravida,
  • Whose spouse had a singleton pregnancy,
  • With no prior experience of pregnancy, childbirth, or parenting,
  • With no history of miscarriage, curettage, or perinatal loss,
  • Whose spouse had no pregnancy-related complications or risk factors,
  • Who had not previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

You may not qualify if:

  • Participants were excluded if they:
  • Had a spouse whose pregnancy was outside the 20-32 week gestation range,
  • Had a spouse with a multiple pregnancy,
  • Had any pregnancy-related complications or risk factors (high risk),
  • Had prior experience of pregnancy, birth, or parenting,
  • Had experienced miscarriage, curettage, or perinatal loss,
  • Had previously attended any childbirth preparation training, pregnancy information classes, or parenting courses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33000, Turkey (Türkiye)

Location

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
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

May 1, 2025

Study Start

February 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 14, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations