Prenatal AttachmentNCT06953544
The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level
A study testing Father-Sensitive Education and Standardized birth education in people with Prenatal Attachment and Childbirth Preparation Program, run by Sevil Güner at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Attachment, Childbirth Preparation Program, Antenatal Education
- What is being tested?
- Father-Sensitive Education and Standardized birth education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 14 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Prenatal Attachment, Childbirth Preparation Program, Antenatal Education, Paternal Behavior
- Being tested
- Father-Sensitive Education, Standardized birth education
- Keywords
- Childbirth Preparation Program, Paternal attachment, Antenatal attachment, Midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Father-Sensitive EducationBehavioural
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.
Standardized birth educationBehavioural
The control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Father-Sensitive Birt Education | Experimental | The father-sensitive birth education group was given "Father-Sensitive Childbirth Preparation Education" consisting of four sessions. Receives: 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. Receives: Behavioral: Standardized birth education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after completing the 12-hour father-sensitive childbirth preparation class
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Feb 2024
- Primary completion1 Oct 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal AttachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevil Güner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevil Güner, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953544
- Sponsor's protocol ID
- MERSINU*GHOSHANLİ*001
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Father-Sensitive Childbirth Education on Prenatal Paternal Attachment Level
- ClinicalTrials.gov ID
- NCT06953544
- Acronym / sponsor ID
- MERSINU*GHOSHANLİ*001
- Conditions
- Prenatal Attachment, Childbirth Preparation Program, Antenatal Education, Paternal Behavior
- Keywords
- Childbirth Preparation Program, Paternal attachment, Antenatal attachment, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Sevil GünerUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Father-Sensitive Birt Education | Experimental | Behavioral: Father-Sensitive EducationThe father-sensitive birth education group was given "Father-Sensitive Childbirth Preparation Education" consisting of four sessions. |
| Standardized Birt Education | Active comparator | Behavioral: Standardized birth educationThe control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Father-Sensitive Educationhe 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. | Behavioural | Father-Sensitive Birt Education |
| Standardized birth educationThe control group received a total of 12 hours of standard childbirth preparation training, consisting of four three-hour sessions. | Behavioural | Standardized Birt Education |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Father-Sensitive Education and Standardized birth education in people with Prenatal Attachment and Childbirth Preparation Program, run by Sevil Güner at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal Antenatal Attachment Scale (PAAS) total score mean (time frame: 14 days after completing the 12-hour father-sensitive childbirth preparation class). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.