The Effect of Mother's Anxiety, Fear and Prenatal Connection in the Prenatal Education Given to Pregnant Women Via Podcast During the Non-stress Test

March 9, 2024 updated by: YASEMİN AYDIN KARTAL

The Effect of Prenatal Education Given to Pregnant Women Via Podcast During the Non-Stress Test on Maternal Anxiety, Fear and Prenatal Attachment

This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The research, planned in a randomized controlled quasi-experimental design, will be carried out with nulliparous pregnant women (n:104) who apply to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital. Pregnant women who voluntarily participate in the research will be divided into intervention (n: 52) and control (n: 52) groups according to the computer-assisted simple random sampling technique. The intervention group, nulliparous pregnant women, will listen to 3 podcasts of 5-6 minutes. Pregnant women in the control group will be given a booklet on the pregnancy and birth process from the Ministry of Health as part of routine care. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The population of the research will consist of nulliparous pregnant women who applied to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital in 2024. The sample of the research will consist of 104 pregnant women who meet the sample selection criteria and participate in the study. Pregnant women who volunteer to participate in the research will be included in the study. The study will be carried out in two groups: the "intervention group", which receives prenatal education with podcasts, and the "control group", which receives routine care. Computer-assisted randomization will be used in the study, and the number of cases will be entered through the program with the URL address https://www. Random assignment was made to 52) and control (n:52) groups. Consent will be obtained from pregnant women using the "Informed Voluntary Consent Form" before the application. Pregnant women assigned to the intervention group will be given a 20-minute NST procedure while listening to a podcast on a Samsung Galaxy J7 Prime phone. Podcast duration is planned to be 5-6 minutes and 3 podcasts will be listened to. Pregnant women in the control group receive T.R. treatment within the scope of routine care. The Ministry of Health's booklet on pregnancy and birth process will be provided. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study. Before the data collection forms are implemented, an "Informed Voluntary Consent Form" will be applied to the participants. State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all groups before and after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34668
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being primigravida
  • Speaking and understanding Turkish
  • To be literate
  • Being a pregnant woman admitted to Istanbul Bağcılar Training and Research Hospital Non-Stress Test outpatient clinic or obstetrics and gynaecology open observation department,
  • 24 to 32 weeks of gestation in nulliparous pregnant women
  • Singleton pregnancy

Exclusion Criteria:

  • Pregnant women diagnosed with high-risk pregnancy
  • Fetal-obstetric complement complement (preterm labor, hypertension, diabetes, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: İntervention group (n:52)
Pregnant women assigned to the intervention group (52) will be listened to podcasts on a Samsung Galaxy J7 Prime brand phone while undergoing a 20-minute NST procedure.Pregnant women in the intervention group will be made to listen to 3 podcasts consisting of 3 modules lasting an average of 5-6 minutes during the Non-Stress Test. After the podcast is prepared, it will be edited in line with expert opinion and its final version will be given.
Other: Prenatal education management delivered via podcast
Pregnant women assigned to the intervention group (52) will be listened to podcasts on a Samsung Galaxy J7 Prime brand phone while undergoing a 20-minute NST procedure
No Intervention: Control group (n:52)
Pregnant women assigned to the control group were given T.R. treatment within the scope of routine care. The Ministry of Health's "Pregnancy and Birth Process" booklet will be given and the pregnant woman's questions will be answered on the topics she wants to get information about.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Introductory Information Form
Time Frame: 10 minutes
Reported based on the literature, the form includes questions regarding socio-demographic data and obstetric characteristics of nulliparous pregnant women. Regarding demographic characteristics, the form includes age, gestational age, education level, income may change, spousal support, spouse and individual baby wish status, prenatal follow-up numbers, pregnancy planning status, prenatal education and information availability and where it was obtained. has been given.
10 minutes
State-Trait Anxiety Inventory(D-SKE)
Time Frame: 10 minutes
It contains two separate scales: State Anxiety Inventory (SCI) and Trait Anxiety Inventory (SCI), which consist of a total of 40 items. There are two types of expressions in D-SKE. Direct expressions express negative emotions, while reverse expressions express positive emotions. In the DCI, the reverse statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. In SCI, reverse statements constitute items 21, 26, 27, 30, 33, 36 and 39. After the total weights of direct and reverse expressions are found separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. A predetermined and unchanging value is added to this number. This unchanged value is 50 for DKE and 35 for SKE. The final value obtained is the individual's anxiety score. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
10 minutes
Wijma Birth Expectation/Experience Scale Version A (W-DEQ A)
Time Frame: 10 minutes
The scale consists of 33 items. The answers on the scale are numbered from 0 to 5 and are in a six-point Likert type. 0 means "completely" and 5 means "not at all". The minimum score that can be obtained from the scale is 0 and the maximum score is 165. It is calculated by reversing items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31 of the scale. It is stated that as the score obtained from the scale increases, the fear of birth experienced by women increases. W-DEQ A scores on the scale; women who have low degree of fear of childbirth (W-DEQ A score ≤37), women who have moderate fear of childbirth (those with W-DEQ A score=38-65), women who have severe fear of childbirth (W-DEQ A score=66-84). ) and those with clinical degree of fear of childbirth (W-DEQ A score ≥85).
10 minutes
Prenatal Attachment Inventory (PBI)
Time Frame: 10 minutes
PBI was developed to explain the thoughts, feelings and situations experienced by women during pregnancy and to determine the level of attachment to the baby in the prenatal period and consists of a total of 21 items. Each item in the PBI is a four-point Likert-type scale with a score between 1 and 4. In PBI, "Never" is scored as 1, "Sometimes" as 2, "Frequently" as 3, and "Always" as 4. A minimum of 21 and a maximum of 84 points can be obtained from PBI. The increase in the score obtained from the PBI indicates that the attachment level of the pregnant woman also increases.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory(D-SKE)
Time Frame: 10 minutes
It contains two separate scales: State Anxiety Inventory (SCI) and Trait Anxiety Inventory (SCI), which consist of a total of 40 items. There are two types of expressions in D-SKE. Direct expressions express negative emotions, while reverse expressions express positive emotions. In the DCI, the reverse statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. In SCI, reverse statements constitute items 21, 26, 27, 30, 33, 36 and 39. After the total weights of direct and reverse expressions are found separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. A predetermined and unchanging value is added to this number. This unchanged value is 50 for DKE and 35 for SKE. The final value obtained is the individual's anxiety score. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
10 minutes
Wijma Birth Expectation/Experience Scale Version A (W-DEQ A)
Time Frame: 10 minutes
The scale consists of 33 items. The answers on the scale are numbered from 0 to 5 and are in a six-point Likert type. 0 means "completely" and 5 means "not at all". The minimum score that can be obtained from the scale is 0 and the maximum score is 165. It is calculated by reversing items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31 of the scale. It is stated that as the score obtained from the scale increases, the fear of birth experienced by women increases. W-DEQ A scores on the scale; women who have low degree of fear of childbirth (W-DEQ A score ≤37), women who have moderate fear of childbirth (those with W-DEQ A score=38-65), women who have severe fear of childbirth (W-DEQ A score=66-84). ) and those with clinical degree of fear of childbirth (W-DEQ A score ≥85).
10 minutes
Prenatal Attachment Inventory (PBI)
Time Frame: 10 minutes
PBI was developed to explain the thoughts, feelings and situations experienced by women during pregnancy and to determine the level of attachment to the baby in the prenatal period and consists of a total of 21 items. Each item in the PBI is a four-point Likert-type scale with a score between 1 and 4. In PBI, "Never" is scored as 1, "Sometimes" as 2, "Frequently" as 3, and "Always" as 4. A minimum of 21 and a maximum of 84 points can be obtained from PBI. The increase in the score obtained from the PBI indicates that the attachment level of the pregnant woman also increases.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
YASEMİN AYDIN KARTAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBÜ-AYDINKARTAL-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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