Prenatal EducationNCT06313723
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
A study testing Prenatal education management delivered via podcast in people with Prenatal Education, run by YASEMİN AYDIN KARTAL at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Education
- What is being tested?
- Prenatal education management delivered via podcast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant women diagnosed with high-risk pregnancy
- Fetal-obstetric complement complement (preterm labor, hypertension, diabetes, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prenatal Education
- Being tested
- Prenatal education management delivered via podcast
- Keywords
- podcast, pregnancy, non-stress testing, fear of birth, prenatal attachment, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal education management delivered via podcastOther
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
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (n:52) | Experimental | 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. Receives: Other: Prenatal education management delivered via podcast |
| Control group (n:52) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
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.
Measured: 10 minutes
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).
Measured: 10 minutes
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.
Measured: 10 minutes
Secondary outcomes (3)
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.
Measured: 10 minutes
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).
Measured: 10 minutes
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled single-blind quasi-experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YASEMİN AYDIN KARTAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313723
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-030
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prenatal Education Given to Pregnant Women Via Podcast During the Non-Stress Test on Maternal Anxiety, Fear and Prenatal Attachment
- ClinicalTrials.gov ID
- NCT06313723
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-030
- Conditions
- Prenatal Education
- Keywords
- podcast, pregnancy, non-stress testing, fear of birth, prenatal attachment, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- YASEMİN AYDIN KARTALUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled single-blind quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| İntervention group (n:52) | Experimental | Other: Prenatal education management delivered via podcastPregnant 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. |
| Control group (n:52) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant women diagnosed with high-risk pregnancy
- Fetal-obstetric complement complement (preterm labor, hypertension, diabetes, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal education management delivered via podcastPregnant 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 | Other | İntervention group (n:52) |
Primary outcome
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.
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.
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).
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.
3 secondary outcomes
State-Trait Anxiety Inventory(D-SKE)
Time frame: 10 minutes
Wijma Birth Expectation/Experience Scale Version A (W-DEQ A)
Time frame: 10 minutes
Prenatal Attachment Inventory (PBI)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal education management delivered via podcast in people with Prenatal Education, run by YASEMİN AYDIN KARTAL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assoc. Prof. Dr. Yasemin AYDIN KARTAL (0543 287 00 29, yasemin.aydin@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.