Effect of Antenatal Education on Fear of ChildBirth

November 8, 2023 updated by: Leyla Kaya, Saglik Bilimleri Universitesi

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

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 Locations

      • Istanbul, Turkey, 34668
        • Sağlık Bilimleri Üniversitesi
      • Istanbul, Turkey, 34865
        • Kartal Dr.Lütfi Kırdar City Hospital
      • İstanbul, Turkey, 34668
        • Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

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

14 years to 31 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Women who do not meet the sample selection criteria

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
The women allocated in experimental group will be given antenatal education for 6 weeks
education
No Intervention: control
The women allocated for the control group will receive prenatal care services routinely provided at the outpatient clinics of the same hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 20 to 36 weeks gestational age
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.
6-8 weeks postpartum
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
at 20 to 36 weeks gestational age
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
at 20 to 36 weeks gestational age
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
6-8 weeks postpartum
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
at 20 to 36 weeks gestational age
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
6-8 weeks postpartum
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
6-8 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Leyla Kaya, PhD, Zeynep Kamil Women and Children's Diseases Training and Research Hospital

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 (Actual)

October 1, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

October 1, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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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