Clinical trial NCT06148415: The Effect of Fetal Heartbeat Monitoring on Prenatal Attachment and Partner Adjustment
Official title: Evaluation of Prenatal Attachment Levels and Spousal Adjustment in Couples Performing Fetal Heartbeat Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Attachment
Fetal Heart Sound
Partner compatibility
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial conducted with experimental and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of prenatal maternal attachment level
timeFrame: The Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the first interview (day 1).
measure: Assessment of prenatal maternal attachment level
timeFrame: Prenatal Maternal Attachment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
measure: Assessment of prenatal paternal attachment level
timeFrame: The Prenatal Father Attachment Scale will be administered to all expectant fathers in both groups at the first interview (day 1).
measure: Assessment of prenatal paternal attachment level
timeFrame: The Prenatal Father Attachment Scale will be administered to all prospective fathers in both groups in the last interview (day 15).
measure: Assessment of spousal adjustment of pregnant women
timeFrame: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups in the first interview (day 1).
measure: Assessment of spousal adjustment of pregnant women
timeFrame: Prenatal Self-Assessment Scale will be administered to all pregnant women in both groups at the last interview (day 15).
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Esra KARATAŞ OKYAY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.