Antenatal EducationNCT04907630
Antenatal Education Based on Improving Health Literacy
A study testing Antenatal Education in people with Antenatal Education, run by Balikesir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antenatal Education
- What is being tested?
- Antenatal Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer primiparous pregnant women
- 18 years and over,
- No have any disease
- In the second trimester
Who cannot join
- Not participating in five-week education,
- Any complications developed during the education period
- Voluntarily leaving.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University, Faculty of Health Sciences, Department of Midwifery Çağış Campus
Balıkesir, 10100
About this study
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
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.
Read the 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.
- Conditions
- Antenatal Education
- Being tested
- Antenatal Education
- Keywords
- Health Literacy, Antenatal Education, General Self-Efficacy, Fear of Childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal EducationBehavioural
Also called antenatal education based on improving health literacy
educational intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Antenatal Education |
| intervention group-Antenatal Education (AE) | Experimental | It is the group that gives antenatal education (AE) Receives: Behavioral: Antenatal Education |
| Control group | Experimental | No Intervention Receives: Behavioral: Antenatal Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: five weeks
Secondary outcomes (1)
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).
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Jul 2018
- Primary completion1 Apr 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antenatal EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Aslantekin Özçoban, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907630
- Sponsor's protocol ID
- 0000-0002-040
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04907630
- Acronym / sponsor ID
- 0000-0002-040
- Conditions
- Antenatal Education
- Keywords
- Health Literacy, Antenatal Education, General Self-Efficacy, Fear of Childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group-antenatal education of health literacy (HL-AE) | Experimental | Behavioral: Antenatal EducationIt is the group that is given antenatal education based on improving health literacy (HL-AE). |
| intervention group-Antenatal Education (AE) | Experimental | Behavioral: Antenatal EducationIt is the group that gives antenatal education (AE) |
| Control group | Experimental | Behavioral: Antenatal EducationNo Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer primiparous pregnant women
- 18 years and over,
- No have any disease
- In the second trimester
Key exclusion criteria (3 listed)
- Not participating in five-week education,
- Any complications developed during the education period
- Voluntarily leaving.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal EducationAlso: antenatal education based on improving health literacyeducational intervention | Behavioural | Control group, intervention group-Antenatal Education (AE), intervention group-antenatal education of health literacy (HL-AE) |
Primary outcome
Prenatal Self-Evaluation Questionnaire (PSEQ)
Time frame: 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.
Fear of Childbirth and The Postpartum Period Scale
Time frame: 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).
General Self-Efficacy Scale
Time frame: 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).
1 secondary outcome
Turkey Health Literacy Scale-32
Time frame: five weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal Education in people with Antenatal Education, run by Balikesir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Self-Evaluation Questionnaire (PSEQ) (time frame: five weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.