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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05584618
Other study ID # 08.06.2022-73
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 31, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Education
education

Locations

Country Name City State
Turkey Kartal Dr.Lütfi Kirdar City Hospital Istanbul
Turkey Saglik Bilimleri Universitesi Istanbul
Turkey Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale (PSS) The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkiran 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
Primary Perceived Stress Scale (PSS) The scale developed by Cohen, Kamarck and Mermelstein (1983) and its Turkish adaptation was carried out by Eskin, Harlak, Demirkiran 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
Primary 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 Firat (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
Primary 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 Yaldiz (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
Primary 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 Yaldiz (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
Primary 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
Primary 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
Primary 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
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