Clinical trial NCT06734754: The Effect of Fetal Heart Sound Played by Parents Diagnosed With Risky Pregnancy on Attachment and Anxiety
Official title: The Effect of Fetal Heart Sound Played by Parents Diagnosed With Risky Pregnancy on Attachment and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attachment
Risk Pregnancy
Anxiety
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 272
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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 ".

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: The effect of auscultated fetal heart sound on the anxiety level of the expectant mother
timeFrame: 7 days
measure: The effect of auscultated fetal heart sound on the maternal attachment of the expectant mother.
timeFrame: 7 days
measure: The effect of auscultated fetal heart sound on the anxiety level of the expectant father
timeFrame: 7 days
measure: The effect of fetal heart sound playback on paternal attachment
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Hilal
state: Yeşilyurt
Study officials:
References: