Effect of Antenatal Education on Fear of ChildBirth

Sponsor

Saglik Bilimleri Universitesi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05584618

Collaborator

(none)

100

Enrollment

Locations

Arms

9.6

Anticipated Duration (Months)

33.3

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fear of Childbirth Stress	Other: Education	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized controlled trialA randomized controlled trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 13, 2022

Anticipated Study Completion Date :

Jul 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention The women allocated in experimental group will be given antenatal education for 6 weeks	Other: Education 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

Arm

Intervention/Treatment

Experimental: intervention

The women allocated in experimental group will be given antenatal education for 6 weeks

Other: Education

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

Outcome Measures

Primary Outcome Measures

Perceived Stress Scale (PSS) [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) [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) [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) [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) [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) [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) [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Saglık Bilimleri Universitesi	Istanbul	Turkey	34668
2	Zeynep Kamil Women's and Children's Diseases Training and Research Hospital	İstanbul	Turkey	34668
3	Kartal Dr.Lütfi Kırdar City Hospital	Istanbul	Turkey	34865