Prenatal Attachment, Maternal Expectations, Paternal InvolvementFHS-ATTACHNCT06965647
Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal and Paternal Attachment
A study testing Partner-Conducted Fetal Heart Sound Measurement in people with Prenatal Attachment, Maternal Expectations, Paternal Involvement, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of fetal heart sound (FHS) measurement performed by the partner on prenatal maternal and paternal expectations and attachment levels. A total of 120 couples (60 intervention, 60 control) participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prenatal Attachment, Maternal Expectations, Paternal Involvement
- What is being tested?
- Partner-Conducted Fetal Heart Sound Measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 2 Sep 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Women with diagnosed psychiatric conditions
- Couples unwilling to participate
- Incomplete data forms
- Those who moved out of the study area during follow-up
- Women without their partners during visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal-Paternal Expectations and Maternal-Paternal Attachment: An Experimental Study
This randomized controlled study aims to evaluate the effect of fetal heart sound (FHS) measurement performed by the partner on prenatal maternal and paternal expectations and attachment levels. A total of 120 couples (60 intervention, 60 control) participated in the study.
Read the detailed description
This experimental study was conducted to determine the effect of partner-conducted fetal heart sound (FHS) measurement on prenatal maternal and paternal expectations and attachment. The study included 120 couples (60 intervention, 60 control) whose pregnancies were between 28 and 38 weeks, and who were registered at Hasköy Family Health Center in Muş, Turkey. In the intervention group, the father was trained in Leopold maneuvers and performed the FHS measurement twice - once during 28-32 weeks and again during 33-38 weeks of gestation. Data collection tools included the Prenatal Maternity Expectations Scale, Prenatal Paternity Expectations Scale, Prenatal Attachment Inventory, and the Paternal Antenatal Attachment Scale. Data were collected before the first FHS measurement (pre-test) and after the second (post-test). The control group received standard prenatal monitoring by healthcare staff without involving the partner. The study was approved by the Malatya Clinical Research Ethics Committee (Approval No: 2022/3968).
- Being tested
- Partner-Conducted Fetal Heart Sound Measurement
- Keywords
- motherhood, fatherhood, prenatal attachment, partner involvement, fetal heart sound, parental expectations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner-Conducted Fetal Heart Sound MeasurementBehavioural
Expectant fathers in the intervention group were trained in basic Leopold maneuvers and fetal heart sound measurement using a Doppler device. Under the supervision of a midwife, fathers located the fetus's back, applied gel, and measured the heart sound during prenatal visits at 28-32 and 33-38 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Couples who met the inclusion criteria were invited from Hasköy Family Health Center. Based on national prenatal care guidelines, two sessions were scheduled at 28-32 weeks and 33-38 weeks of gestation. Fathers were trained on Leopold maneuvers and fetal heart sound measurement. Under midwife supervision, fathers performed Leopold maneuvers and fetal heart sound measurements using a Doppler device. The intervention was applied twice. Receives: Behavioral: Partner-Conducted Fetal Heart Sound Measurement |
| Control Group | No intervention | Couples in the control group received standard prenatal follow-up. At 28-32 and 33-38 weeks, data were collected using the same tools without any intervention. During routine visits, the fetal heart sound measurement and Leopold maneuvers were performed by the midwife as part of standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Paternal Attachment Level
Change in paternal attachment scores, measured using the Prenatal Paternal Attachment Scale (PPAS), before and after partner-conducted fetal heart sound measurement.
Measured: From 28-38 weeks of gestation (approximately 10 weeks)
Secondary outcomes (2)
Prenatal Maternal Attachment Level
Change in maternal attachment scores, measured using the Prenatal Attachment Inventory (PAI), before and after the intervention.
Measured: From 28-38 weeks of gestation (approximately 10 weeks)
Parental Expectations (Mother and Father)
Change in maternal and paternal expectations measured using validated Maternity and Paternity Expectation Scales before and after the intervention.
Measured: From 28-38 weeks of gestation (approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start15 Jul 2022
- Primary completion15 Jun 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Attachment, Maternal Expectations, Paternal InvolvementStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled design with parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader ATABEY, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965647
- Sponsor's protocol ID
- 10576553
- Acronym
- FHS-ATTACH
- Status last verified
- Dec 2024
- First submitted
- 18 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Partner-Conducted Fetal Heart Sound Measurement on Maternal-Paternal Expectations and Maternal-Paternal Attachment: An Experimental Study
- ClinicalTrials.gov ID
- NCT06965647
- Acronym / sponsor ID
- FHS-ATTACH / 10576553
- Keywords
- motherhood, fatherhood, prenatal attachment, partner involvement, fetal heart sound, parental expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 11 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 randomized controlled study aims to evaluate the effect of fetal heart sound (FHS) measurement performed by the partner on prenatal maternal and paternal expectations and attachment levels. A total of 120 couples (60 intervention, 60 control) participated in the study.
Detailed description
This experimental study was conducted to determine the effect of partner-conducted fetal heart sound (FHS) measurement on prenatal maternal and paternal expectations and attachment. The study included 120 couples (60 intervention, 60 control) whose pregnancies were between 28 and 38 weeks, and who were registered at Hasköy Family Health Center in Muş, Turkey. In the intervention group, the father was trained in Leopold maneuvers and performed the FHS measurement twice - once during 28-32 weeks and again during 33-38 weeks of gestation. Data collection tools included the Prenatal Maternity Expectations Scale, Prenatal Paternity Expectations Scale, Prenatal Attachment Inventory, and the Paternal Antenatal Attachment Scale. Data were collected before the first FHS measurement (pre-test) and after the second (post-test). The control group received standard prenatal monitoring by healthcare staff without involving the partner. The study was approved by the Malatya Clinical Research Ethics Committee (Approval No: 2022/3968).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled design with parallel groups
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Partner-Conducted Fetal Heart Sound MeasurementCouples who met the inclusion criteria were invited from Hasköy Family Health Center. Based on national prenatal care guidelines, two sessions were scheduled at 28-32 weeks and 33-38 weeks of gestation. Fathers were trained on Leopold maneuvers and fetal heart sound measurement. Under midwife supervision, fathers performed Leopold maneuvers and fetal heart sound measurements using a Doppler device. The intervention was applied twice. |
| Control Group | No intervention | –Couples in the control group received standard prenatal follow-up. At 28-32 and 33-38 weeks, data were collected using the same tools without any intervention. During routine visits, the fetal heart sound measurement and Leopold maneuvers were performed by the midwife as part of standard care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Women with diagnosed psychiatric conditions
- Couples unwilling to participate
- Incomplete data forms
- Those who moved out of the study area during follow-up
- Women without their partners during visits
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 |
|---|---|---|
| Partner-Conducted Fetal Heart Sound MeasurementExpectant fathers in the intervention group were trained in basic Leopold maneuvers and fetal heart sound measurement using a Doppler device. Under the supervision of a midwife, fathers located the fetus's back, applied gel, and measured the heart sound during prenatal visits at 28-32 and 33-38 weeks of gestation. | Behavioural | Intervention Group |
Primary outcome
Prenatal Paternal Attachment Level
Time frame: From 28-38 weeks of gestation (approximately 10 weeks)
Change in paternal attachment scores, measured using the Prenatal Paternal Attachment Scale (PPAS), before and after partner-conducted fetal heart sound measurement.
2 secondary outcomes
Prenatal Maternal Attachment Level
Time frame: From 28-38 weeks of gestation (approximately 10 weeks)
Parental Expectations (Mother and Father)
Time frame: From 28-38 weeks of gestation (approximately 10 weeks)
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 11 May 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD).
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 Partner-Conducted Fetal Heart Sound Measurement in people with Prenatal Attachment, Maternal Expectations, Paternal Involvement, run by Inonu University 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 0 inclusion and 5 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 11 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?
Prenatal Paternal Attachment Level (time frame: From 28-38 weeks of gestation (approximately 10 weeks)). 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 11 May 2025.