Antenatal Education Based on Improving Health Literacy

Sponsor
Balikesir University (Other)
Overall Status
Completed
CT.gov ID
NCT04907630
Collaborator
(none)
182
1
3
15
12.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Antenatal Education
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Antenatal Education Based on Improving Health Literacy on Adaptation of Pregnancy, General Self-Efficacy, Fear of Childbirth, and Health Literacy in Primiparous Pregnant Women: A Randomized Control Study
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group-antenatal education of health literacy (HL-AE)

It is the group that is given antenatal education based on improving health literacy (HL-AE).

Behavioral: Antenatal Education
educational intervention
Other Names:
  • antenatal education based on improving health literacy
  • Experimental: intervention group-Antenatal Education (AE)

    It is the group that gives antenatal education (AE)

    Behavioral: Antenatal Education
    educational intervention
    Other Names:
  • antenatal education based on improving health literacy
  • Experimental: Control group

    No Intervention

    Behavioral: Antenatal Education
    educational intervention
    Other Names:
  • antenatal education based on improving health literacy
  • Outcome Measures

    Primary Outcome Measures

    1. Prenatal Self-Evaluation Questionnaire (PSEQ) [five weeks]

      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 Beydağ and Mete (Cronbach's alpha=.83) (Beydağ & 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.

    2. Fear of Childbirth and The Postpartum Period Scale [five weeks]

      The scale was developed by Kitapçıoğlu 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 (Kitapçıoğlu et al., 2008).

    3. General Self-Efficacy Scale [five weeks]

      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 Yıldırım and İlhan, 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).

    Secondary Outcome Measures

    1. Turkey Health Literacy Scale-32 [five weeks]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Balikesir University, Faculty of Health Sciences, Department of Midwifery Çağış Campus Balıkesir Turkey 10100

    Sponsors and Collaborators

    • Balikesir University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Filiz Aslantekin Özçoban, Principal Investigator, Balikesir University
    ClinicalTrials.gov Identifier:
    NCT04907630
    Other Study ID Numbers:
    • 0000-0002-040
    First Posted:
    Jun 1, 2021
    Last Update Posted:
    Jun 1, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Filiz Aslantekin Özçoban, Principal Investigator, Balikesir University

    Study Results

    No Results Posted as of Jun 1, 2021