- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06313723
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
104
Phase
- 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
- Name: Assoc. Prof. Dr. Yasemin AYDIN KARTAL
- Phone Number: 0543 287 00 29
- Email: yasemin.aydin@sbu.edu.tr
Study Contact Backup
- Name: Midwife Sena YÖN
- Phone Number: 05443853899
- Email: 221001126@ogrenci.sbu.edu.tr
Study Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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)
April 1, 2024
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
October 31, 2024
Study Registration Dates
First Submitted
March 9, 2024
First Submitted That Met QC Criteria
March 9, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 9, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID 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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