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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04907630
Other study ID # 0000-0002-040
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date October 1, 2019

Study information

Verified date May 2021
Source Balikesir University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: This study was aimed to evaluate the effect of antenatal education based on improving health literacy on the adaptation of pregnancy, general self-efficacy, fear of childbirth, and health literacy in primiparous pregnant women. Design: It was a randomized controlled trial. Method: The research was carried out in a city located in the Marmara region of Turkey between July 2018 and April 2019. It was conducted with three groups, including one control (n=73) and two intervention groups (n=109). One of the intervention group was given antenatal education based on improving health literacy (n=53), and the other was only provided with antenatal education (n=56). Pregnancy Information Form, Prenatal Self-Evaluation Questionnaire, Pregnancy Related Anxiety Scale, General Self-Efficacy Scale, and Health Literacy-TR32 scale were used for data collection.


Description:

Background: Pregnant women get themselves ready to give birth, maternity and parenting through antenatal education. These trainings make it easier to adapt to the processes in which pregnant women experience change. They also provide an important opportunity to support and maintain the competence and motivation to manage health responsibility. Aim: To evaluate the impact of antenatal education intervention based on improving health literacy in order for primiparous pregnant women to; accept the pregnancy and adopt the role of maternity; increase the level of general self-efficacy and health literacy; reduce the fear of childbirth; and support the level of breastfeeding. Design: It is an experimental and randomized controlled trial. Method: The research was carried out in a town located in the Marmara region of Turkey between April 2019 and July 2018. It was conducted with three groups, including one control (73) and two training groups (109). One of the training group was given antenatal education based on improving health literacy (HL-AE) (53), and the other was only provided with antenatal education (AE) (56). Pregnancy identification form, prenatal self-evaluation questionnaire, pregnancy related anxiety scale, general self-efficacy scale, Turkey health literacy -32 scale and postpartum data collection form were used for data collection.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date October 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteer primiparous pregnant women - 18 years and over, - No have any disease - In the second trimester Exclusion Criteria: - Not participating in five-week education, - Any complications developed during the education period - Voluntarily leaving.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Antenatal Education
educational intervention

Locations

Country Name City State
Turkey Balikesir University, Faculty of Health Sciences, Department of Midwifery Çagis Campus Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prenatal Self-Evaluation Questionnaire (PSEQ) The scale was developed by Lederman et al. in 1979 to evaluate the adaptation of women to pregnancy and birth in the prenatal period (Lederman & Weis, 2009). The scale is a four-point Likert type consisting of seven subscales and 79 items. The highest score that can be obtained from the scale is 316 and the lowest one is 79. The Turkish validity and reliability of the scale was made by Beydag and Mete (Cronbach's alpha=.83) (Beydag & Mete, 2008).Two subscales of "acceptance of pregnancy" and "defining the role of maternity" were used for the research. Values that can be taken as an acceptance of pregnancy are between 14-56. Values that can be taken as the acceptance of the role of maternity are 15-60. A low score indicates that the mother's adaptation is better. five weeks
Primary Fear of Childbirth and The Postpartum Period Scale The scale was developed by Kitapçioglu et al in 2008 to evaluate the concerns about delivery and postpartum period. It is a five-point Likert-type scale. Scale includes 61 question items, and they are scored between 0-10 (Cronbach's alpha=.95). Decrease in the scale mean score shows that the concerns about childbirth are decreasing (Kitapçioglu et al., 2008). five weeks
Primary General Self-Efficacy Scale An original 23-item form was developed by Sherer et al (Sherer et al., 1982). The validity and reliability of the Turkish version was made by Yildirim and Ilhan, and a scale of 17 questions was created. The scale's total score ranges from 17 to 85 (Cronbach alpha=.80). The increase in the score shows that the belief in self-efficacy has increased (Yildirim & Ilhan, 2010). five weeks
Secondary Turkey Health Literacy Scale-32 It is a self-report scale developed to evaluate health literacy in adult individuals. The scale is based on the conceptual framework developed by the European Health Literacy Research Consortium. It was developed by Abacigil et al. (Cronbach alpha=.95). Each item is 4 degrees to indicate 1=Very easy, 2=Easy, 3=Hard, 4=Very hard. Codes were reversed when calculating the score. In terms of ease of calculation, the total score has been standardized with the help of the following formula to take a value between 0-50 (Abacigil et al., 2019). five weeks
See also
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Completed NCT04097782 - Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women N/A