Pregnancy RelatedNCT06148415
The Effect of Fetal Heartbeat Monitoring on Prenatal Attachment and Partner Adjustment
A study testing Fetal Heartbeat Monitoring Group in people with Pregnancy Related, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this interventional study is to obtain information about determining the effect of the following drugs. To evaluate prenatal attachment levels and spousal adjustment in couples with fetal heart rate monitoring. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Fetal Heartbeat Monitoring Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Mar 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to communicate,
- Primigravida,
- Over 18 years of age,
- 32 weeks of gestation and above and without any diagnosed risk (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios, multiple pregnancy) in the current pregnancy,
- Those who do not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) will be included in the study.
Who cannot join
- Separated from his wife,
- In the first trimester of pregnancy,
- Those with any diagnosed risk in the mother or baby will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prenatal Attachment Levels and Spousal Adjustment in Couples Performing Fetal Heartbeat Monitoring
The aim of this interventional study is to obtain information about determining the effect of the following drugs. To evaluate prenatal attachment levels and spousal adjustment in couples with fetal heart rate monitoring.
The main questions it aims to answer are:
- Does fetal heart rate monitoring affect the attachment of pregnant women?
- Does fetal heart rate monitoring affect fathers' attachment?
- Does fetal heart rate monitoring affect pregnant women's adjustment to motherhood?
Read the detailed description
Data will be collected from women who meet the inclusion criteria and agree to participate in the study. Data collection tools will be collected in 2 stages by the researcher using a questionnaire form by face-to-face interview method in a suitable room in previously determined hospitals.
In the first stage (Day 1); couples who meet the inclusion criteria will be informed about the study and written consent will be obtained from those who agree to participate in the study. The pre-test data collection phase will be completed by applying data collection tools. Then, the prospective fathers will be trained by the researchers on how to apply the 1st and 2nd leopold maneuvers using visual materials. Each couple will be provided with a stethoscope to listen to the fetal heartbeat, and they will be given a schedule to listen to the fetal heartbeat together for 5-10 minutes at least once a day for 15 days. During the training, the couples will be able to detect the fetal heartbeat in a healthy way and an appointment will be made for the second phase and the first phase of the study will be completed (approximately 10-15 minutes).
In the second phase (Day 15); the researchers will contact the women again and invite them to the ASM. Then, stethoscopes and charts will be received from the couples, data collection tools will be applied again and post-test data will be collected (1-5 minutes) and the data collection phase will be completed.
Pre-test data will be collected by applying data collection tools (Personal Information Form, Prenatal Self-Assessment Scale, Prenatal Mother Attachment Scale and Prenatal Father Attachment Scale) to the couples in the intervention group (Couples Monitoring Fetal Heartbeat) in the first interview. Then, the researchers will provide training on listening to the fetal heartbeat in the first stage and in the last session (Day 15), the data collection tools will be applied to the couples again and the post-test data will be collected and thus the data collection process will be completed.
No intervention will be applied to the women in the control group, however, in the first interview (Day 1), data collection forms (Personal Information Form, Prenatal Self-Assessment Scale, Prenatal Maternal Attachment Scale and Prenatal Paternal Attachment Scale) will be applied and pre-test data will be collected. Then, the post-test data will be collected by applying the data collection forms to the women again in the last session (Day 15) simultaneously with the application schedule in the experimental group and the data collection process will be completed.
- Conditions
- Pregnancy Related
- Being tested
- Fetal Heartbeat Monitoring Group
- Keywords
- Attachment, Fetal Heart Sound, Partner compatibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Heartbeat Monitoring GroupBehavioural
Fetal Heartbeat Monitoring Group
| Study group | Role | What they receive |
|---|---|---|
| Fetal Heartbeat Monitoring Group | Experimental | The prospective fathers will be trained by the investigators on how to perform the 1st and 2nd leopold maneuvers using visual materials. Each couple will be provided with a stethoscope to listen to the fetal heartbeat and will be given a schedule to listen to the fetal heartbeat together for 5-10 minutes at least once a day for 15 days.
1. Leopold maneuver (Posture): The first maneuver is performed to determine the height of the fundus and the part that is located on the fundus.
2. Leopold's maneuver (Position: back right, back left): This maneuver is used to determine which side the fetal back is on. On palpation, the side with the baby's back is flat and firmer, and the other side feels bumpy. Receives: Behavioral: Fetal Heartbeat Monitoring Group |
| Control | No intervention | Standard care group without fetal heart rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of prenatal maternal attachment level
The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.
Measured: The Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the first interview (day 1).
Assessment of prenatal maternal attachment level
The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.
Measured: Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
Assessment of prenatal paternal attachment level
The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.
Measured: The Prenatal Father Attachment Scale will be administered to all expectant fathers in both groups at the first interview (day 1).
Assessment of prenatal paternal attachment level
The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.
Measured: The Prenatal Father Attachment Scale will be administered to all prospective fathers in both groups in the last interview (day 15).
Assessment of spousal adjustment of pregnant women
This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.
Measured: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups in the first interview (day 1).
Assessment of spousal adjustment of pregnant women
This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.
Measured: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Crossover
- Model description
- Randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra KARATAŞ OKYAY, Kahramanmaras Sutcu Imam University
- Investigators
- Esra KARATAŞ OKYAY, PhD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148415
- Sponsor's protocol ID
- KSUESRAKARATASOKYAY004
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared.
Publications
Guney E, Ucar T. Effect of the fetal movement count on maternal-fetal attachment. Jpn J Nurs Sci. 2019 Jan;16(1):71-79. doi: 10.1111/jjns.12214. Epub 2018 May 17.
PubMed 29774647
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prenatal Attachment Levels and Spousal Adjustment in Couples Performing Fetal Heartbeat Monitoring
- ClinicalTrials.gov ID
- NCT06148415
- Acronym / sponsor ID
- KSUESRAKARATASOKYAY004
- Conditions
- Pregnancy Related
- Keywords
- Attachment, Fetal Heart Sound, Partner compatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 28 Nov 2023 (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 aim of this interventional study is to obtain information about determining the effect of the following drugs. To evaluate prenatal attachment levels and spousal adjustment in couples with fetal heart rate monitoring.
The main questions it aims to answer are:
- Does fetal heart rate monitoring affect the attachment of pregnant women?
- Does fetal heart rate monitoring affect fathers' attachment?
- Does fetal heart rate monitoring affect pregnant women's adjustment to motherhood?
Detailed description
Data will be collected from women who meet the inclusion criteria and agree to participate in the study. Data collection tools will be collected in 2 stages by the researcher using a questionnaire form by face-to-face interview method in a suitable room in previously determined hospitals.
In the first stage (Day 1); couples who meet the inclusion criteria will be informed about the study and written consent will be obtained from those who agree to participate in the study. The pre-test data collection phase will be completed by applying data collection tools. Then, the prospective fathers will be trained by the researchers on how to apply the 1st and 2nd leopold maneuvers using visual materials. Each couple will be provided with a stethoscope to listen to the fetal heartbeat, and they will be given a schedule to listen to the fetal heartbeat together for 5-10 minutes at least once a day for 15 days. During the training, the couples will be able to detect the fetal heartbeat in a healthy way and an appointment will be made for the second phase and the first phase of the study will be completed (approximately 10-15 minutes).
In the second phase (Day 15); the researchers will contact the women again and invite them to the ASM. Then, stethoscopes and charts will be received from the couples, data collection tools will be applied again and post-test data will be collected (1-5 minutes) and the data collection phase will be completed.
Pre-test data will be collected by applying data collection tools (Personal Information Form, Prenatal Self-Assessment Scale, Prenatal Mother Attachment Scale and Prenatal Father Attachment Scale) to the couples in the intervention group (Couples Monitoring Fetal Heartbeat) in the first interview. Then, the researchers will provide training on listening to the fetal heartbeat in the first stage and in the last session (Day 15), the data collection tools will be applied to the couples again and the post-test data will be collected and thus the data collection process will be completed.
No intervention will be applied to the women in the control group, however, in the first interview (Day 1), data collection forms (Personal Information Form, Prenatal Self-Assessment Scale, Prenatal Maternal Attachment Scale and Prenatal Paternal Attachment Scale) will be applied and pre-test data will be collected. Then, the post-test data will be collected by applying the data collection forms to the women again in the last session (Day 15) simultaneously with the application schedule in the experimental group and the data collection process will be completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Fetal Heartbeat Monitoring Group | Experimental | Behavioral: Fetal Heartbeat Monitoring GroupThe prospective fathers will be trained by the investigators on how to perform the 1st and 2nd leopold maneuvers using visual materials. Each couple will be provided with a stethoscope to listen to the fetal heartbeat and will be given a schedule to listen to the fetal heartbeat together for 5-10 minutes at least once a day for 15 days. 1. Leopold maneuver (Posture): The first maneuver is performed to determine the height of the fundus and the part that is located on the fundus. 2. Leopold's maneuver (Position: back right, back left): This maneuver is used to determine which side the fetal back is on. On palpation, the side with the baby's back is flat and firmer, and the other side feels bumpy. |
| Control | No intervention | –Standard care group without fetal heart rate monitoring |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to communicate,
- Primigravida,
- Over 18 years of age,
- 32 weeks of gestation and above and without any diagnosed risk (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios, multiple pregnancy) in the current pregnancy,
- Those who do not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) will be included in the study.
Key exclusion criteria (3 listed)
- Separated from his wife,
- In the first trimester of pregnancy,
- Those with any diagnosed risk in the mother or baby will not be included in the study.
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 Heartbeat Monitoring GroupFetal Heartbeat Monitoring Group | Behavioural | Fetal Heartbeat Monitoring Group |
Primary outcome
Assessment of prenatal maternal attachment level
Time frame: The Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the first interview (day 1).
The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.
Assessment of prenatal maternal attachment level
Time frame: Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
The scale has 19 items in total and each item focuses on the feelings, attitudes and behaviors of the pregnant woman towards the fetus. The scale is Likert-type and each item is scored between 1-5 (5= represents very strong feelings towards the fetus; 1= represents the absence of feelings towards the fetus). There are two sub-dimensions in the scale. The quality of attachment subscale refers to the quality of the pregnant woman's emotional experience of the fetus. The second sub-dimension, time spent on attachment, refers to the intensity of the time the pregnant woman spends thinking, talking and touching the fetus. A high score obtained from the scale indicates a high degree of attachment.
Assessment of prenatal paternal attachment level
Time frame: The Prenatal Father Attachment Scale will be administered to all expectant fathers in both groups at the first interview (day 1).
The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.
Assessment of prenatal paternal attachment level
Time frame: The Prenatal Father Attachment Scale will be administered to all prospective fathers in both groups in the last interview (day 15).
The Prenatal Father Attachment Scale is based on measuring the father's feelings and thoughts towards the developing baby in the womb in line with the father's experiences in the last two weeks. There are 9 reverse items in the scale consisting of 16 items. Reverse items are scored by reversing them. The scale has 2 sub-dimensions: "quality of attachment (8 items)" and "time spent on attachment (8 items)". The items are scored between 1-5 and a minimum score of 16 and a maximum score of 80 is obtained from the scale. The higher the score obtained from the scale, the higher the prenatal attachment is considered to be.
Assessment of spousal adjustment of pregnant women
Time frame: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups in the first interview (day 1).
This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.
Assessment of spousal adjustment of pregnant women
Time frame: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
This four-point Likert-type scale consists of 79 items. The scale has seven sub-dimensions: thoughts about her own and her baby's health, acceptance of pregnancy, acceptance of the maternal role, readiness for childbirth, fear of childbirth, relationship status with her own mother and relationship status with her partner. Each subscale contains between 10-15 items. Each item in the scale is evaluated on a four-point scale, and adaptation to pregnancy is scored from 1 to 4 (4: Very much defines, 3: Partially defines, 2: Somewhat defines, 1: Does not define at all). In this study, the relationship with spouse sub-dimension of the scale was used.
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 Oct 2024.
- Background: PubMed 29774647Guney E, Ucar T. Effect of the fetal movement count on maternal-fetal attachment. Jpn J Nurs Sci. 2019 Jan;16(1):71-79. doi: 10.1111/jjns.12214. Epub 2018 May 17.
- Description citation linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared.
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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.
Esra KARATAŞ OKYAY, PhD principal investigator
Kahramanmaras Sutcu Imam University
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 Heartbeat Monitoring Group in people with Pregnancy Related, run by Kahramanmaras Sutcu Imam 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 5 inclusion and 3 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 Oct 2024. 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?
Assessment of prenatal maternal attachment level (time frame: The Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the first interview (day 1).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148415, which also lists 1 linked publication.
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 Oct 2024.