AttachmentNCT06734754
The Effect of Fetal Heart Sound Played by Parents Diagnosed With Risky Pregnancy on Attachment and Anxiety
A study testing fetal heart sound listening in people with Attachment and Risk Pregnancy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The research was designed as a randomized controlled experimental type to determine the effect of fetal heart sound played to parents diagnosed with risky pregnancies on attachment and anxiety. Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attachment, Risk Pregnancy, Anxiety
- What is being tested?
- fetal heart sound listening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Mar 2025
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Being diagnosed with a risky pregnancy (pregnancy under 18 years of age, pregnancy over 35 years of age, birth interval of less than two years, experiencing one of the prenatal hemorrhages, premature rupture of membranes, hypertensive conditions during pregnancy, hyperemesis gravidarum, multiple pregnancies, gestational diabetes, placenta previa Having a history of medical diseases such as polyhydramnios, oligohydramnios, heart disease, thyroid diseases, having blood diseases, infectious diseases, Rh incompatibility, pregnancy with assisted reproductive techniques, varicose veins, smoking, alcohol, substance use)
- No verbal communication or reading and writing disabilities,
- Having a smartphone and internet access,
- 27-38. week of pregnancy,
- Women who agreed to participate in the study voluntarily and whose consent was obtained
- Pregnant women who were not previously or currently diagnosed with a psychiatric disease were included in the sample.
Who cannot join
- • Not diagnosed with high-risk pregnancy,
- Those who do not live with their spouse,
- Unmarried
- Pregnant women with communication difficulties or mental disabilities were not included in the study.
- Participating in the study and then deciding to leave,
- Those who fill out the data forms incompletely or do not complete them will be excluded from the research.
Trial locations and contacts
1 site in 1 country.
About this study
The research was designed as a randomized controlled experimental type to determine the effect of fetal heart sound played to parents diagnosed with risky pregnancies on attachment and anxiety. With the results obtained from this study, it is aimed to contribute to the limited literature on the effect of fetal heart sound played to parents diagnosed with risky pregnancy on attachment and anxiety.
Research question or Hypothesis(ies) and Purpose(s):
Read more
The purpose of this study is to determine the effect of fetal heart sound played to parents diagnosed with high-risk pregnancy on attachment and anxiety.
H1-a: Listening to the fetal heart sound reduces the anxiety level of the expectant mother.
H1-b: Listening to the fetal heart sound increases the maternal attachment of the expectant mother.
H1-c: Listening to the fetal heart sound reduces the anxiety level of the expectant father.
H1-d: Listening to the fetal heart sound increases the paternal attachment of the expectant father.
The research will be conducted on 2 groups: 1 experimental and 1 control group. In order to obtain pre-test data of the research, couples will fill in the determined measurement tools. The couples' contact information will be recorded, their appointment dates will be determined and an appointment card will be issued. The intervention applied by the researcher to the participants in the experimental group will be completed in 7 days. At the end of the 7th day, post-test data will be obtained using measurement tools.
Pretest data will be obtained using measurement tools in the first interview with the control group. No interventional intervention will be applied to the participants in the control group by the researcher. Post-test data will be obtained 7 days later by applying the same measurement tools.
Read the detailed description
Criteria for Inclusion in the Research:
- Being diagnosed with a risky pregnancy (pregnancy under 18 years of age, pregnancy over 35 years of age, birth interval of less than two years, experiencing one of the prenatal hemorrhages, premature rupture of membranes, hypertensive conditions during pregnancy, hyperemesis gravidarum, multiple pregnancies, gestational diabetes, placenta previa , having a medical disease history such as polyhydramnios, oligohydramnios, heart disease, thyroid diseases, blood diseases, experiencing one of the infectious diseases, Rh incompatibility, getting pregnant with assisted reproductive techniques, varicose veins, smoking, alcohol, substance use)
- No verbal communication or reading and writing disabilities,
- Has a smart phone and internet access,
- 27-38. week of pregnancy,
- Women who agreed to participate in the study voluntarily and whose consent was obtained
- Pregnant women who were not previously or currently diagnosed with a psychiatric disease were included in the sample.
Criteria for Exclusion from the Research:
- Participating in the study and then deciding to leave,
- Those who fill out the data forms incompletely or do not complete them will be excluded from the research.Exclusion Criteria from the Study:
- Not diagnosed with high-risk pregnancy,
- Those who do not live with their spouse,
- Unmarried
- Pregnant women with communication difficulties or mental disabilities were not included in the study.
Variables of the research:
Independent Variable of the Research: Demographic characteristics of the couples Dependent Variable of the Research: Couples' attachment and anxiety states Control variables of the study: Some individual characteristics of the couples (age, education, income level, employment status, place of residence)
Data collection tools:
While data were being collected, Personal Information Form-Female , Personal Information Form-Male , "Prenatal Mother Attachment Scale ", "Prenatal Father Attachment Scale " and "State Anxiety Scale" were used ".
- Conditions
- Attachment, Risk Pregnancy, Anxiety
- Being tested
- fetal heart sound listening
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal heart sound listeningDevice
The pregnant women in the experimental group and their partners listened to fetal heart sounds for 7 days. After obtaining pre-test data from the participants in the intervention group, the midwifery intervention to be implemented was explained. A fetal heart rate monitoring device, which will be given to couples to listen to the fetal heart sound before sleep, was introduced. They were told that they had to listen to the fetal heart sound at least 7 times using this device. A supporting application was downloaded to the pregnant woman's phone for the installation of the fetal heart rate monitoring device. The way of using the application and the operation steps were introduced. It was explained to the couples that the application can detect the baby's heartbeat within seconds thanks to its smart search technology, and also provides step-by-step guidance by giving live feedback.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | fetal heart sound listening Receives: Device: fetal heart sound listening |
| Control Group | No intervention | fetal heart sound was not played |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of auscultated fetal heart sound on the anxiety level of the expectant mother
State Anxiety Scale: It is scored according to the severity of the emotions or behaviors expressed in the scale as (1) not at all, (2) a little, (3) a lot, (4) completely. The 10 items of the scale are reverse scored: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. A score of 4 from the scale indicates high anxiety in plain expressions, while it indicates low anxiety in reverse expressions. When calculating the scale score, 50 points are added to the difference between the total weighted scores of reverse expressions and plain expressions, and the total score varies between 20-80. A score below 36 indicates no anxiety, a score between 37 and 42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
Measured: 7 days
The effect of auscultated fetal heart sound on the maternal attachment of the expectant mother.
Prenatal Maternal Attachment Scale consists of 19 items and two subscales. The scale is a 5-point Likert type, 11 items are reverse scored and the items take values between 1-5. A high score from the scale indicates a high degree of attachment.
Measured: 7 days
The effect of auscultated fetal heart sound on the anxiety level of the expectant father
State Anxiety Scale: It is scored according to the severity of the emotions or behaviors expressed in the scale as (1) not at all, (2) a little, (3) a lot, (4) completely. The 10 items of the scale are reverse scored: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. A score of 4 from the scale indicates high anxiety in plain expressions, while it indicates low anxiety in reverse expressions. When calculating the scale score, 50 points are added to the difference between the total weighted scores of reverse expressions and plain expressions, and the total score varies between 20-80. A score below 36 indicates no anxiety, a score between 37 and 42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
Measured: 7 days
The effect of fetal heart sound playback on paternal attachment
Prenatal Father Attachment Scale consists of 16 items and two subscales. Increasing score indicates higher degree of attachment. The scale is a 5-point Likert type and 9 items are reverse scored.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Feb 2024
- Primary completion10 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttachmentStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Dincer, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734754
- Sponsor's protocol ID
- Inonu U.
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fetal Heart Sound Played by Parents Diagnosed With Risky Pregnancy on Attachment and Anxiety
- ClinicalTrials.gov ID
- NCT06734754
- Acronym / sponsor ID
- Inonu U.
- Conditions
- Attachment, Risk Pregnancy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Dec 2024 (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.
The research was designed as a randomized controlled experimental type to determine the effect of fetal heart sound played to parents diagnosed with risky pregnancies on attachment and anxiety. With the results obtained from this study, it is aimed to contribute to the limited literature on the effect of fetal heart sound played to parents diagnosed with risky pregnancy on attachment and anxiety.
Research question or Hypothesis(ies) and Purpose(s):
The purpose of this study is to determine the effect of fetal heart sound played to parents diagnosed with high-risk pregnancy on attachment and anxiety.
H1-a: Listening to the fetal heart sound reduces the anxiety level of the expectant mother.
H1-b: Listening to the fetal heart sound increases the maternal attachment of the expectant mother.
H1-c: Listening to the fetal heart sound reduces the anxiety level of the expectant father.
H1-d: Listening to the fetal heart sound increases the paternal attachment of the expectant father.
The research will be conducted on 2 groups: 1 experimental and 1 control group. In order to obtain pre-test data of the research, couples will fill in the determined measurement tools. The couples' contact information will be recorded, their appointment dates will be determined and an appointment card will be issued. The intervention applied by the researcher to the participants in the experimental group will be completed in 7 days. At the end of the 7th day, post-test data will be obtained using measurement tools.
Pretest data will be obtained using measurement tools in the first interview with the control group. No interventional intervention will be applied to the participants in the control group by the researcher. Post-test data will be obtained 7 days later by applying the same measurement tools.
Detailed description
Criteria for Inclusion in the Research:
- Being diagnosed with a risky pregnancy (pregnancy under 18 years of age, pregnancy over 35 years of age, birth interval of less than two years, experiencing one of the prenatal hemorrhages, premature rupture of membranes, hypertensive conditions during pregnancy, hyperemesis gravidarum, multiple pregnancies, gestational diabetes, placenta previa , having a medical disease history such as polyhydramnios, oligohydramnios, heart disease, thyroid diseases, blood diseases, experiencing one of the infectious diseases, Rh incompatibility, getting pregnant with assisted reproductive techniques, varicose veins, smoking, alcohol, substance use)
- No verbal communication or reading and writing disabilities,
- Has a smart phone and internet access,
- 27-38. week of pregnancy,
- Women who agreed to participate in the study voluntarily and whose consent was obtained
- Pregnant women who were not previously or currently diagnosed with a psychiatric disease were included in the sample.
Criteria for Exclusion from the Research:
- Participating in the study and then deciding to leave,
- Those who fill out the data forms incompletely or do not complete them will be excluded from the research.Exclusion Criteria from the Study:
- Not diagnosed with high-risk pregnancy,
- Those who do not live with their spouse,
- Unmarried
- Pregnant women with communication difficulties or mental disabilities were not included in the study.
Variables of the research:
Independent Variable of the Research: Demographic characteristics of the couples Dependent Variable of the Research: Couples' attachment and anxiety states Control variables of the study: Some individual characteristics of the couples (age, education, income level, employment status, place of residence)
Data collection tools:
While data were being collected, Personal Information Form-Female , Personal Information Form-Male , "Prenatal Mother Attachment Scale ", "Prenatal Father Attachment Scale " and "State Anxiety Scale" were used ".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: fetal heart sound listeningfetal heart sound listening |
| Control Group | No intervention | –fetal heart sound was not played |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- • Being diagnosed with a risky pregnancy (pregnancy under 18 years of age, pregnancy over 35 years of age, birth interval of less than two years, experiencing one of the prenatal hemorrhages, premature rupture of membranes, hypertensive conditions during pregnancy, hyperemesis gravidarum, multiple pregnancies, gestational diabetes, placenta previa Having a history of medical diseases such as polyhydramnios, oligohydramnios, heart disease, thyroid diseases, having blood diseases, infectious diseases, Rh incompatibility, pregnancy with assisted reproductive techniques, varicose veins, smoking, alcohol, substance use)
Key exclusion criteria (6 listed)
- • Not diagnosed with high-risk pregnancy,
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 |
|---|---|---|
| fetal heart sound listeningThe pregnant women in the experimental group and their partners listened to fetal heart sounds for 7 days. After obtaining pre-test data from the participants in the intervention group, the midwifery intervention to be implemented was explained. A fetal heart rate monitoring device, which will be given to couples to listen to the fetal heart sound before sleep, was introduced. They were told that they had to listen to the fetal heart sound at least 7 times using this device. A supporting application was downloaded to the pregnant woman's phone for the installation of the fetal heart rate monitoring device. The way of using the application and the operation steps were introduced. It was explained to the couples that the application can detect the baby's heartbeat within seconds thanks to its smart search technology, and also provides step-by-step guidance by giving live feedback. | Device | Experimental Group |
Primary outcome
The effect of auscultated fetal heart sound on the anxiety level of the expectant mother
Time frame: 7 days
State Anxiety Scale: It is scored according to the severity of the emotions or behaviors expressed in the scale as (1) not at all, (2) a little, (3) a lot, (4) completely. The 10 items of the scale are reverse scored: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. A score of 4 from the scale indicates high anxiety in plain expressions, while it indicates low anxiety in reverse expressions. When calculating the scale score, 50 points are added to the difference between the total weighted scores of reverse expressions and plain expressions, and the total score varies between 20-80. A score below 36 indicates no anxiety, a score between 37 and 42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
The effect of auscultated fetal heart sound on the maternal attachment of the expectant mother.
Time frame: 7 days
Prenatal Maternal Attachment Scale consists of 19 items and two subscales. The scale is a 5-point Likert type, 11 items are reverse scored and the items take values between 1-5. A high score from the scale indicates a high degree of attachment.
The effect of auscultated fetal heart sound on the anxiety level of the expectant father
Time frame: 7 days
State Anxiety Scale: It is scored according to the severity of the emotions or behaviors expressed in the scale as (1) not at all, (2) a little, (3) a lot, (4) completely. The 10 items of the scale are reverse scored: 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. A score of 4 from the scale indicates high anxiety in plain expressions, while it indicates low anxiety in reverse expressions. When calculating the scale score, 50 points are added to the difference between the total weighted scores of reverse expressions and plain expressions, and the total score varies between 20-80. A score below 36 indicates no anxiety, a score between 37 and 42 indicates mild anxiety, and a score of 42 and above indicates high anxiety.
The effect of fetal heart sound playback on paternal attachment
Time frame: 7 days
Prenatal Father Attachment Scale consists of 16 items and two subscales. Increasing score indicates higher degree of attachment. The scale is a 5-point Likert type and 9 items are reverse scored.
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 9 May 2025.
- Individual participant dataSharing planned: No
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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 fetal heart sound listening in people with Attachment and Risk Pregnancy, 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 6 inclusion and 6 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 9 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?
The effect of auscultated fetal heart sound on the anxiety level of the expectant mother (time frame: 7 days). The study lists 4 primary outcomes in all. 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 9 May 2025.