NCT04907630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

May 22, 2021

Last Update Submit

May 26, 2021

Conditions

Keywords

Health LiteracyAntenatal EducationGeneral Self-EfficacyFear of Childbirth

Outcome Measures

Primary Outcomes (3)

  • 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 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.

    five weeks

  • Fear of Childbirth and The Postpartum Period Scale

    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).

    five weeks

  • 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 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).

    five weeks

Secondary Outcomes (1)

  • Turkey Health Literacy Scale-32

    five weeks

Study Arms (3)

intervention group-antenatal education of health literacy (HL-AE)

EXPERIMENTAL

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

Behavioral: Antenatal Education

intervention group-Antenatal Education (AE)

EXPERIMENTAL

It is the group that gives antenatal education (AE)

Behavioral: Antenatal Education

Control group

EXPERIMENTAL

No Intervention

Behavioral: Antenatal Education

Interventions

educational intervention

Also known as: antenatal education based on improving health literacy
Control groupintervention group-Antenatal Education (AE)intervention group-antenatal education of health literacy (HL-AE)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer primiparous pregnant women
  • years and over,
  • No have any disease
  • In the second trimester

You may not qualify if:

  • Not participating in five-week education,
  • Any complications developed during the education period
  • Voluntarily leaving.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir University, Faculty of Health Sciences, Department of Midwifery Çağış Campus

Balıkesir, 10100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Prenatal Education

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2021

First Posted

June 1, 2021

Study Start

July 1, 2018

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations