Fear of ChildbirthNCT05584618
Effect of Antenatal Education on Fear of ChildBirth
A study testing Education in people with Fear of Childbirth and Stress, run by Saglik Bilimleri Universitesi at 3 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous pregnant women 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
- Fear of Childbirth, Stress
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 31 Oct 2023
- 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
- Literate
- Childbirth at fullterm (born at 38-42 weeks)
- Nulliparous women
- Women between the ages of 18-35
- Singleton pregnancy in 20 and 36 weeks of gestation
- Having a healthy newborn
Show all 15Show fewer
- No participation in another prenatal program
- Absence of any psychiatric illness or comorbidities
- No use medications for a diagnosed mental disorder
- Baby with normal birth weight and APGAR score of 8 and above
- Women who have not developed postpartum complications
- Women without complicated/high-risk pregnancies, who do not experience a perinatal death or stillbirth
- Speaks and understands Turkish
- Women with a total fear of childbirth score W-DEQ-A ≥60 will be included.
- Women who give birth through vaginal route
Who cannot join
- Women who do not meet the sample selection criteria
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Saglık Bilimleri Universitesi
Istanbul, 34668
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Istanbul, 34668
Kartal Dr.Lütfi Kırdar City Hospital
Istanbul, 34865
About this study
Official title: Evaluation of Antenatal Education on Fear of ChildBirth, Depression, Anxiety, Maternal Self-Efficacy, and Delivery Mode in Primiparous Pregnant Women: A Prospective Randomized Controlled Study
The aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous pregnant women
Read the detailed description
There is still a lack of evidence regarding the effects of antenatal education on birth fear, maternal self-efficacy, anxiety, stress, depression, and mode of delivery. Therefore, this study aimed to investigate the effects of antenatal education on birth fear, anxiety, stress, depression, maternal self-efficacy, and mode of delivery
- Conditions
- Fear of Childbirth, Stress
- Being tested
- Education
- Keywords
- antenatal education, fear of childbirth, depression, anxiety, stress, maternal self-efficacy, mode of delivery
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
education
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The women allocated in experimental group will be given antenatal education for 6 weeks Receives: Other: Education |
| control | No intervention | The women allocated for the control group will receive prenatal care services routinely provided at the outpatient clinics of the same hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.
Measured: at 20 to 36 weeks gestational age
Perceived Stress Scale (PSS)
The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.
Measured: 6-8 weeks postpartum
Wijma Delivery Expectancy/ Experience Questionnaire (W-DEQ- A)
The scale was developed by Klaas and Barbro Wijma to measure the fear of childbirth and its Turkish adaptation and validity and reliability were conducted by Körükçü, Kukulu, and Fırat (2012, 2018). The scale consists of 33 items and the answers are enumerated between 0 and 5 as a 6-item liker scale, in which 0 means "completely" and 5 means "none". The range of the total score of the scale is between 0 and 165. The higher the scores, the higher the fear of birth experienced by women
Measured: at 20 to 36 weeks gestational age
Multidimensional Scale of Perceived Social Support (MSPSS)
The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95
Measured: at 20 to 36 weeks gestational age
Multidimensional Scale of Perceived Social Support (MSPSS)
The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95
Measured: 6-8 weeks postpartum
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89
Measured: at 20 to 36 weeks gestational age
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89
Measured: 6-8 weeks postpartum
The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B)
W-DEQ- B was developed by Wijma et al. to determine postpartum feelings and thoughts about the fear of women who gave vaginal birth (1998). The scale consists of a total of 33 6-point Likert-type questions. Each item is defined as 1 with a score between 1-6 and 6 as none. The minimum score on the scale is 33, while the maximum score is 198. The higher the scores, the higher the fear of birth experienced by women
Measured: 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Oct 2022
- Primary completion1 Nov 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya, Saglik Bilimleri Universitesi
- Investigators
- Leyla Kaya, PhD, Principal investigator, Zeynep Kamil Women and Children's Diseases Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584618
- Sponsor's protocol ID
- 08.06.2022-73
- Status last verified
- Nov 2023
- First submitted
- 1 Oct 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaya L, Bi̇lge Y, Keles E, Erkok U, Kaya Z. Effect of antenatal education on fear of childbirth, mental health, and perceived stress in primigravid pregnant women: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2025 Dec 7;25(1):1342. doi: 10.1186/s12884-025-08544-6.
PubMed 41353123
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antenatal Education on Fear of ChildBirth, Depression, Anxiety, Maternal Self-Efficacy, and Delivery Mode in Primiparous Pregnant Women: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05584618
- Acronym / sponsor ID
- 08.06.2022-73
- Conditions
- Fear of Childbirth, Stress
- Keywords
- antenatal education, fear of childbirth, depression, anxiety, stress, maternal self-efficacy, mode of delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Oct 2022 (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.
The aim of this study was to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, maternal self-efficacy, and mode of delivery in primiparous pregnant women
Detailed description
There is still a lack of evidence regarding the effects of antenatal education on birth fear, maternal self-efficacy, anxiety, stress, depression, and mode of delivery. Therefore, this study aimed to investigate the effects of antenatal education on birth fear, anxiety, stress, depression, maternal self-efficacy, and mode of delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: EducationThe women allocated in experimental group will be given antenatal education for 6 weeks |
| control | No intervention | –The women allocated for the control group will receive prenatal care services routinely provided at the outpatient clinics of the same hospital |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Literate
- Childbirth at fullterm (born at 38-42 weeks)
- Nulliparous women
- Women between the ages of 18-35
- Singleton pregnancy in 20 and 36 weeks of gestation
Key exclusion criteria (1 listed)
- Women who do not meet the sample selection criteria
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 |
|---|---|---|
| Educationeducation | Other | intervention |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: at 20 to 36 weeks gestational age
The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.
Perceived Stress Scale (PSS)
Time frame: 6-8 weeks postpartum
The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkıran and Dereboy (2013), which aims to measure how stressful some situations in a person's life are perceived, consists of 14 items. The "Perceived Stress Scale" consists of the dimensions of "Perception of Inadequate Self-Efficacy" and "Perception of Stress/Discomfort". Participants evaluated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The internal consistency coefficient of the Turkish scale was 0.84 and the test-retest reliability was 0.87.
Wijma Delivery Expectancy/ Experience Questionnaire (W-DEQ- A)
Time frame: at 20 to 36 weeks gestational age
The scale was developed by Klaas and Barbro Wijma to measure the fear of childbirth and its Turkish adaptation and validity and reliability were conducted by Körükçü, Kukulu, and Fırat (2012, 2018). The scale consists of 33 items and the answers are enumerated between 0 and 5 as a 6-item liker scale, in which 0 means "completely" and 5 means "none". The range of the total score of the scale is between 0 and 165. The higher the scores, the higher the fear of birth experienced by women
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: at 20 to 36 weeks gestational age
The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 6-8 weeks postpartum
The scale developed by Zimet et al. in 1988 and Turkish adaptation, validity and reliability studies were carried out by Eker, Arkar, and Yaldız (2001). The MSPSS is a 12-item scale, and includes 3 groups about the source of support, each of which consisting of 4 items, which are family, friend, and a special person. In the Cronbach's Alpha Method that was used to measure the internal consistency, values were found to be between 0.80 and 0.95
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: at 20 to 36 weeks gestational age
The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: 6-8 weeks postpartum
The Turkish adaptation of the scale, developed in 2007 by Tennant et al., was done by Keldal in 2015. It is a five-point Likert-type scale, including 14 items. The lowest and the highest scores are 14 and 70 points. High scores indicate high mental wellbeing. Cronbach's alpha value of the scale was determined as 0.89
The Wijma Delivery Expectancy/Experience Questionnaire B version (W-DEQ-B)
Time frame: 6-8 weeks postpartum
W-DEQ- B was developed by Wijma et al. to determine postpartum feelings and thoughts about the fear of women who gave vaginal birth (1998). The scale consists of a total of 33 6-point Likert-type questions. Each item is defined as 1 with a score between 1-6 and 6 as none. The minimum score on the scale is 33, while the maximum score is 198. The higher the scores, the higher the fear of birth experienced by women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 41353123Kaya L, Bi̇lge Y, Keles E, Erkok U, Kaya Z. Effect of antenatal education on fear of childbirth, mental health, and perceived stress in primigravid pregnant women: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2025 Dec 7;25(1):1342. doi: 10.1186/s12884-025-08544-6.
- Individual participant dataSharing planned: No
Related trials for Fear of Childbirth
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Enrolling by invitation
The Effect of Podcast Training on Birth Fear in Couples
Pregnancy, Birth Fear
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
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.
Leyla Kaya, PhD principal investigator
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Fear of Childbirth and Stress, run by Saglik Bilimleri Universitesi at 3 sites 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 15 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: at 20 to 36 weeks gestational age). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05584618, which also lists 1 linked publication.
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 9 Nov 2023.