The Effect of Fetal Heartbeat Monitoring on Prenatal Attachment and Partner Adjustment

NCT ID: NCT06148415

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-03-01

Brief Summary

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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

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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

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled trial conducted with experimental and control groups.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single

Study Groups

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Fetal Heartbeat Monitoring Group

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.

Group Type EXPERIMENTAL

Fetal Heartbeat Monitoring Group

Intervention Type BEHAVIORAL

Fetal Heartbeat Monitoring Group

Control

Standard care group without fetal heart rate monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fetal Heartbeat Monitoring Group

Fetal Heartbeat Monitoring Group

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Esra KARATAŞ OKYAY

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esra KARATAŞ OKYAY, PhD

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Locations

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Inonu University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29774647 (View on PubMed)

Related Links

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Other Identifiers

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KSUESRAKARATASOKYAY004

Identifier Type: -

Identifier Source: org_study_id

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