The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level

April 23, 2025 updated by: Sevil Güner

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Yenişehir
      • Mersin, Yenişehir, Turkey, 33000
        • Mersin University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Father-Sensitive Birt Education
The father-sensitive birth education group was given "Father-Sensitive Childbirth Preparation Education" consisting of four sessions.
Behavioral: Father-Sensitive Education
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.
Active Comparator: Standardized Birt Education
The control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions.
Behavioral: Standardized birth education
The control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Paternal Antenatal Attachment Scale (PAAS) total score mean
Time Frame: 14 days after completing the 12-hour father-sensitive childbirth preparation class

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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sevil Güner

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MERSINU*GHOSHANLİ*001

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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