Fear of ChildbirthNCT07268027
Constructivist Prenatal Education Effects
A study testing Constructivist-Based Prenatal Education Group in people with Fear of Childbirth and Self-Efficacy, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Self-Efficacy, Childbirth Education
- What is being tested?
- Constructivist-Based Prenatal Education Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Mar 2026
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registered in the hospital's prenatal school and actively participating in the 3-day training sessions,
- Aged 18 years or older,
- Between 20 and 32 weeks of gestation,
- Having a singleton and low-risk pregnancy,
- Primiparous (expecting their first birth),
- Voluntarily agreeing to participate by signing the written informed consent form,
- Able to read, understand, and communicate in Turkish.
Who cannot join
- Those who have previously given birth vaginally or by cesarean section (multiparous women),
- Those with multiple pregnancies,
- Those who conceived through assisted reproductive techniques,
- Those diagnosed with serious obstetric or medical complications during pregnancy (such as preeclampsia, gestational diabetes, or risk of preterm birth),
- Those with a history of psychiatric diagnosis or currently receiving psychiatric treatment,
- Foreign nationals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
Read the detailed description
The study is a randomized controlled trial. It will be conducted at the prenatal school of Konya City Hospital between December 2025 and May 2026. A total of 126 primiparous pregnant women will be included in the study (intervention group n=63, control group n=63). The intervention group will receive the Constructivist-Based Prenatal Education Program, while the control group will receive the standard prenatal care and education provided by the hospital. Data will be collected using a personal information form, the Fear of Childbirth Scale, the Pain Beliefs Scale, and the Self-Efficacy for Normal Birth Scale.
- Conditions
- Fear of Childbirth, Self-Efficacy, Childbirth Education, Pain
- Being tested
- Constructivist-Based Prenatal Education Group
- Keywords
- Pregnancy Education Program, Fear of Childbirth, Pain Belief, Self-Efficacy for Normal Birth
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constructivist-Based Prenatal Education GroupOther
Also called Education Group
Pregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days. Participants in the intervention group will attend the classes in groups of 15.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Placebo comparator | No additional intervention will be provided to the control group beyond the information they receive during routine prenatal care and in-service trainings, and the control group will consist of pregnant women who do not attend the prenatal school education. After the study is completed, control group participants will be offered the opportunity to attend the standard prenatal school education if they wish. Receives: Other: Constructivist-Based Prenatal Education Group |
| Intervention Group | Experimental | Pregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days. Participants in the intervention group will attend the classes in groups of 15. Receives: Other: Constructivist-Based Prenatal Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.
Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.
Measured: 6 months
Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.
Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.
Measured: 6 months
Comparison of the means of the Fear of Childbirth Scale among pregnant women across groups.
The Fear of Childbirth Scale will be administered to pregnant women. The Respectful Childbirth Care scale ranges from 0 to 160 points (min-max), with higher scores indicating higher fear of childbirth.
Measured: 6 months
Comparison of the Pain Beliefs Scale means among pregnant women across groups.
The Pain Beliefs Scale will be administered to pregnant women.The scale evaluates two types of pain-related beliefs: organic and psychological. It includes 12 items rated on a 6-point Likert scale, with 8 items assessing organic beliefs (pain as a physiological or pathophysiological condition) and 4 items assessing psychological beliefs (pain influenced by anxiety, depression, or external factors). No total score is calculated; each subscale score is the mean of its items. Higher scores indicate stronger beliefs in that specific dimension.
Measured: 6 months
Comparison of mean scores on the Self-Efficacy Scale for Normal Childbirth among pregnant women across groups.
The Self-Efficacy Scale for Normal Childbirth will be administered to pregnant women. Possible scores on the scale are 0-90 (min-max). Higher scores indicate higher self-efficacy levels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies 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
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268027
- Sponsor's protocol ID
- 2025/1052
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 26 May 2026
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07268027
- Acronym / sponsor ID
- 2025/1052
- Conditions
- Fear of Childbirth, Self-Efficacy, Childbirth Education, Pain
- Keywords
- Pregnancy Education Program, Fear of Childbirth, Pain Belief, Self-Efficacy for Normal Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 5 Dec 2025 (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.
The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.
Detailed description
The study is a randomized controlled trial. It will be conducted at the prenatal school of Konya City Hospital between December 2025 and May 2026. A total of 126 primiparous pregnant women will be included in the study (intervention group n=63, control group n=63). The intervention group will receive the Constructivist-Based Prenatal Education Program, while the control group will receive the standard prenatal care and education provided by the hospital. Data will be collected using a personal information form, the Fear of Childbirth Scale, the Pain Beliefs Scale, and the Self-Efficacy for Normal Birth Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | Placebo comparator | Other: Constructivist-Based Prenatal Education GroupNo additional intervention will be provided to the control group beyond the information they receive during routine prenatal care and in-service trainings, and the control group will consist of pregnant women who do not attend the prenatal school education. After the study is completed, control group participants will be offered the opportunity to attend the standard prenatal school education if they wish. |
| Intervention Group | Experimental | Other: Constructivist-Based Prenatal Education GroupPregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days. Participants in the intervention group will attend the classes in groups of 15. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Registered in the hospital's prenatal school and actively participating in the 3-day training sessions,
- Aged 18 years or older,
- Between 20 and 32 weeks of gestation,
- Having a singleton and low-risk pregnancy,
- Primiparous (expecting their first birth),
Key exclusion criteria (6 listed)
- Those who have previously given birth vaginally or by cesarean section (multiparous women),
- Those with multiple pregnancies,
- Those who conceived through assisted reproductive techniques,
- Those diagnosed with serious obstetric or medical complications during pregnancy (such as preeclampsia, gestational diabetes, or risk of preterm birth),
- Those with a history of psychiatric diagnosis or currently receiving psychiatric treatment,
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 |
|---|---|---|
| Constructivist-Based Prenatal Education GroupAlso: Education GroupPregnant women who agree to participate in the study and are assigned to the childbirth preparation education group will receive a Constructivist-Based Prenatal Education Program in the prenatal school department of the hospital for a total of 24 hours over 3 days. Participants in the intervention group will attend the classes in groups of 15. | Other | Intervention Group, No intervention |
Primary outcome
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey.
Time frame: 6 months
Sociodemographic information of pregnant women will be collected through surveys, compared, and reported.
Comparison of obstetric characteristics of pregnant women before the training with a questionnaire.
Time frame: 6 months
Obstetric data of pregnant women will be collected through questionnaires, compared, and reported.
Comparison of the means of the Fear of Childbirth Scale among pregnant women across groups.
Time frame: 6 months
The Fear of Childbirth Scale will be administered to pregnant women. The Respectful Childbirth Care scale ranges from 0 to 160 points (min-max), with higher scores indicating higher fear of childbirth.
Comparison of the Pain Beliefs Scale means among pregnant women across groups.
Time frame: 6 months
The Pain Beliefs Scale will be administered to pregnant women.The scale evaluates two types of pain-related beliefs: organic and psychological. It includes 12 items rated on a 6-point Likert scale, with 8 items assessing organic beliefs (pain as a physiological or pathophysiological condition) and 4 items assessing psychological beliefs (pain influenced by anxiety, depression, or external factors). No total score is calculated; each subscale score is the mean of its items. Higher scores indicate stronger beliefs in that specific dimension.
Comparison of mean scores on the Self-Efficacy Scale for Normal Childbirth among pregnant women across groups.
Time frame: 6 months
The Self-Efficacy Scale for Normal Childbirth will be administered to pregnant women. Possible scores on the scale are 0-90 (min-max). Higher scores indicate higher self-efficacy levels.
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 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Fear of Childbirth
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
Not yet recruiting
Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences
Fear of Childbirth, Childbirth-Related Anxiety
Not yet recruiting
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
Active, not recruiting
The Effects of Positive Birth Experience Sharing and Guided Imagery on Childbirth Self-Efficacy and Fear of Childbirth
Childbirth
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 Constructivist-Based Prenatal Education Group in people with Fear of Childbirth and Self-Efficacy, run by Selcuk 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 7 inclusion and 6 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 26 May 2026. 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. Some participants in this study may receive a placebo. 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?
Comparison of the sociodemographic characteristics of pregnant women before the training with a survey. (time frame: 6 months). The study lists 5 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 26 May 2026.