Effect of Antenatal Education on Fear of ChildBirth
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
1 other identifier
interventional
100
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedNovember 9, 2023
November 1, 2023
1 month
October 1, 2022
November 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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
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
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
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
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
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
6-8 weeks postpartum
Study Arms (2)
intervention
EXPERIMENTALThe women allocated in experimental group will be given antenatal education for 6 weeks
control
NO INTERVENTIONThe women allocated for the control group will receive prenatal care services routinely provided at the outpatient clinics of the same hospital
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Women who do not meet the sample selection criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Saglık Bilimleri Universitesi
Istanbul, 34668, Turkey (Türkiye)
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Kartal Dr.Lütfi Kırdar City Hospital
Istanbul, 34865, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leyla Kaya, PhD
Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 18, 2022
Study Start
October 1, 2022
Primary Completion
November 1, 2022
Study Completion
October 31, 2023
Last Updated
November 9, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share