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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06313723
Other study ID # SBÜ-AYDINKARTAL-030
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date October 31, 2024

Study information

Verified date March 2024
Source Saglik Bilimleri Universitesi
Contact Assoc. Prof. Dr. Yasemin AYDIN KARTAL
Phone 0543 287 00 29
Email yasemin.aydin@sbu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 104
Est. completion date October 31, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Being primigravida - Speaking and understanding Turkish - To be literate - Being a pregnant woman admitted to Istanbul Bagcilar 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey University of Health Sciences Istanbul

Sponsors (1)

Lead Sponsor Collaborator
YASEMIN AYDIN KARTAL

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Introductory Information Form 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
Primary State-Trait Anxiety Inventory(D-SKE) 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
Primary Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) 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
Primary Prenatal Attachment Inventory (PBI) 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 State-Trait Anxiety Inventory(D-SKE) 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
Secondary Wijma Birth Expectation/Experience Scale Version A (W-DEQ A) 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
Secondary Prenatal Attachment Inventory (PBI) 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
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