- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04907630
Antenatal Education Based on Improving Health Literacy
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Balıkesir, Turkey, 10100
- Balikesir University, Faculty of Health Sciences, Department of Midwifery Çağış Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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).
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educational intervention
Other Names:
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Experimental: intervention group-Antenatal Education (AE)
It is the group that gives antenatal education (AE)
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educational intervention
Other Names:
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Experimental: Control group
No Intervention
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educational intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prenatal Self-Evaluation Questionnaire (PSEQ)
Time Frame: five weeks
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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.
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five weeks
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Fear of Childbirth and The Postpartum Period Scale
Time Frame: five weeks
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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).
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five weeks
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General Self-Efficacy Scale
Time Frame: five weeks
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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).
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five weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Turkey Health Literacy Scale-32
Time Frame: five weeks
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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).
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five weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0000-0002-040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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