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Prenatal Education ProgramNCT07699900

The Psychosocial Effects of Prenatal Education With the Indivisible Self Model

A study testing Prenatal Education Program Based on the Indivisible Self Model and The needs-based prenatal education program in people with Prenatal Education Program and Indivisible Self Model, run by Mersin University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study was designed to compare the effects of a prenatal education program based on the Indivisible Self Model with those of a needs-based prenatal education program on psychosocial outcomes among pregnant women. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Prenatal Education Program Based on the Indivisible Self Model and The needs-based prenatal education program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
No sites listed yet
Study dates
15 Oct 2026to 15 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between December 2025 and November 2026,
  • Living in the province of Aksaray,
  • Female,
  • Between the ages of 18-40,
  • Native language Turkish,
  • Between the 28th-32nd weeks of pregnancy,
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  • In their first pregnancy,
  • With a singleton pregnancy,
  • Without any chronic disease or pregnancy complications,
  • Without any diagnosed active psychiatric disorder,
  • Having a mobile phone through which communication can be maintained,
  • Not having participated in another childbirth preparation program,
  • Not having participated in a prenatal psychoeducation and counseling program,
  • Planning the mode of delivery as vaginal birth , women will be included in the sample.

Who cannot join

  • Between December 2025 and November 2026,
  • Those whose native language is not Turkish,
  • Those who are male,
  • Those under 18 years of age or over 40,
  • Those whose pregnancy is less than 28 weeks or more than 32 weeks,
  • Those who have previously ended a pregnancy beyond 20 weeks with childbirth,
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  • Those who are multiparous,
  • Those with multiple pregnancies,
  • Those with any chronic illness,
  • Those who experience any complication related to the mother or fetus/newborn during the research process,
  • Those who need to undergo a cesarean section at any stage of pregnancy or childbirth,
  • Those who develop mental health deviations during the research process and require professional support,
  • Those who did not attend 80% of the training,
  • Those who cannot be reached during the data collection process,
  • Women who wish to withdraw from the study at any stage of the research will be excluded from the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gözde Gökçe İsbir contact

+905057782319

gozdegokce@gmail.com

About this study

Official title: The Impact of a Prenatal Education Program Based on the Indivisible Self Model on Psychosocial Outcomes: A Randomized Controlled Study

This study was designed to compare the effects of a prenatal education program based on the Indivisible Self Model with those of a needs-based prenatal education program on psychosocial outcomes among pregnant women.

Read the detailed description

This study is designed as a single-blind randomized controlled trial to compare the effects of an Indivisible Self Model-based prenatal education program with those of a needs-based prenatal education program on psychosocial outcomes among pregnant women residing in Aksaray, Türkiye, between December 2025 and November 2026. Eligible pregnant women who meet the inclusion criteria will be informed about the study objectives and procedures, and written informed consent will be obtained prior to participation. Participants will be randomly allocated to one of two intervention groups. The intervention group will receive a prenatal education program based on the Indivisible Self Model. Training will be delivered by a researcher-midwife in face-to-face group sessions consisting of 7-8 participants, with a total of five groups. The program will comprise 10 sessions delivered over two consecutive days, with five 45-minute sessions scheduled each day and a 15-minute break between sessions. The curriculum will be structured around the five dimensions of the Indivisible Self Model (Creative Self, Coping Self, Social Self, Essential Self, and Physical Self). Each dimension will include an interactive theoretical component followed by practical activities designed to enhance participants' knowledge, skills, and psychosocial well-being. The control group will receive a needs-based prenatal education program developed according to participants' identified educational needs and the Turkish Ministry of Health's Standard Training Content for Pregnant Information Classes. Training will likewise be delivered face-to-face by the researcher-midwife to groups of 7-8 participants, with five groups in total. The program will consist of 10 sessions conducted over two consecutive days, following the same schedule as the intervention group. The curriculum will focus on pregnancy, childbirth, breastfeeding, postpartum care, and newborn care, aiming to improve participants' knowledge and practical skills. Educational sessions will incorporate interactive teaching strategies, including open-ended questioning, reflective listening, affirmations, and communication techniques appropriate to the learning objectives. Delivery of both educational programs is expected to be completed within a 10-week period. Outcome measures and study questionnaires will be administered in person at three time points: baseline (before the first training session), immediately after completion of the education program, and during the early postpartum period (12-24 hours after birth). The study protocol has been developed and will be conducted in accordance with the CONSORT guidelines.

Being tested
Prenatal Education Program Based on the Indivisible Self Model, The needs-based prenatal education program
Keywords
Indivisible Self Model, prenatal education, psychological well-being, sense of consistency, perception of control and support, self-efficacy at birth
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prenatal Education Program Based on the Indivisible Self ModelOther

    The Indivisible Self Model-based prenatal education program consists of 10 face-to-face group sessions delivered over 2 days. The program is structured around the five components of the Indivisible Self Model (Primary Self, Coping Self, Social Self, Creative Self, and Physical Self) and includes an interactive theoretical presentation and a practical application session for each component. Each training day comprises five 45-minute sessions with a 15-minute break between sessions. The program is designed to promote psychosocial well-being and enhance coping skills among pregnant women.

  • The needs-based prenatal education programOther

    The needs-based prenatal education program consists of 10 face-to-face group sessions delivered over 2 days. Developed according to the Republic of Türkiye Ministry of Health's antenatal education guidelines (updated from 2024 onward), the program is tailored to participants' educational needs and covers pregnancy, childbirth, breastfeeding, postpartum, and newborn care. Each day includes five 45-minute sessions with 15-minute breaks. The program is designed to improve participants' knowledge, skills, and preparedness for childbirth and the postpartum period.

Study groups in NCT07699900
Study groupRoleWhat they receive
Prenatal Education Program Based on the Indivisible Self ModelExperimentalInterviews will be conducted with pregnant women visiting the hospital's midwifery clinic, and they will be informed about the study. Women who agree to participate and meet the inclusion criteria will be informed about the research, and a WhatsApp group will be created for those who wish to participate, and planning will be done. All sessions will be conducted in groups and face-to-face with the women. The sessions will be prepared according to the components of the Indivisible Self Model (Primary Self, Coping Self, Social Self, Creative Self, Physical Self), and for each component, one interactive theoretical presentation session and one practical application session will be planned. The training program will consist of 10 sessions in total, spread over 2 days, with 5 sessions of 45 minutes each day, followed by a 15-minute break.
Receives: Other: Prenatal Education Program Based on the Indivisible Self Model
Needs-Based Prenatal Education ProgramPlacebo comparatorThe needs-based prenatal education program will be prepared based on the content and implementation guidelines published by the Ministry of Health of the Republic of Turkey and updated in maternity schools from 2024 onwards. Participants will be structured into 5 groups of 7-8 people each, who apply to the antenatal clinic and voluntarily participate in the education program to be conducted at the antenatal school; face-to-face group sessions will be held with each group. The program consists of a total of 10 sessions over a two-day period.
Receives: Other: The needs-based prenatal education program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychological Well-Being Scale

    Participants' current levels of psychological well-being will be assessed using the "Psychological Well-Being Scale" developed by Diener et al. (2009-2010). This scale is a measurement tool developed to complement existing well-being measures and aims to assess individuals' socio-psychological well-being levels.

    The scale has a 7-point Likert-type response format and consists of a total of 8 items, each rated from "1 = Strongly disagree" to "7 = Strongly agree". All items consist of positive statements, and the possible scores on the scale range from 8 to 56. Higher scores indicate a higher level of psychological well-being. The internal consistency of the scale was found to be α = .87 using Cronbach's alpha coefficient.

    Measured: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.

  2. Revised Emotional Consistency Scale

    Participants' levels of sense of coherence will be assessed using the Revised Emotional Coherence Scale, developed by Bachem and Maercker in 2016 to improve upon Antonovsky's original model.

    Based on Antonovsky's "Sense of Coherence" theory, this scale aims to assess individuals' perceptions of their life experiences as meaningful, comprehensible, and manageable. The scale uses a five-point Likert-type response format, with items rated from "1 = Not true at all" to "5 = Very true". The minimum possible score is 13, and the maximum is 65. Higher scores indicate that individuals perceive their lives as more meaningful, comprehensible, and manageable, thus indicating a higher level of emotional coherence.

    In the Turkish validity and reliability study of the scale, the Cronbach's alpha coefficient for overall internal consistency was determined as α = 0.82. The alpha values for the sub-dimensions are α = 0.77 for significance, α = 0.77 for compr

    Measured: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.

  3. Self-Efficacy Scale for Normal Birth

    Participants' perceptions of control and support during childbirth will be assessed using the Perceived Control and Support During Childbirth Scale developed by Ford, Ayers, and Wright in 2009.

    The Perceived Control and Support During Childbirth Scale is a scale developed to assess women's perceptions of control and support during childbirth in the postpartum period.The scale consists of three sub-dimensions: internal control, external control, and perceived support, and contains a total of 33 items. The PCS, which has a five-point Likert scale, is rated from "1 = Strongly disagree" to "5 = Strongly agree". The minimum possible score on the scale is 33, and the maximum score is 165. Higher scores indicate that the individual felt more control and perceived more support during childbirth.

    In the Turkish reliability and validity study of the scale, the Cronbach's alpha coefficient was reported as 0.95.

    Measured: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program.

  4. Perceived Control and Support in Childbirth Scale

    Participants' self-efficacy levels will be assessed using the Self-Efficacy Scale for Normal Delivery, developed by Chu et al. in 2017. This scale is an important assessment tool, particularly for determining women's attitudes towards normal delivery and their level of self-confidence during the prenatal period.

    The scale consists of 9 items, each scored from 0 (no confidence at all) to 10 (very confident). Thus, the scale offers 11 different score options for each item. The total scores that can be obtained from the scale range from 0 to 90, with higher scores indicating a high level of self-efficacy belief in normal delivery. Cronbach's alpha coefficient was reported as 0.994 for the 2nd trimester; 0.956 for the 3rd trimester; and 0.980 for the entire scale. The Turkish adaptation, validity, and reliability study of the Self-Efficacy Scale for Normal Birth was carried out by Kahraman and Alparslan in 2022.

    Measured: Postpartum follow-up: Within 12-24 hours after childbirth.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699900
Sponsor's protocol ID
AKaras
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.

    PubMed 26656473
  • Gokce Isbir G, Inci F, Onal H, Yildiz PD. The effects of antenatal education on fear of childbirth, maternal self-efficacy and post-traumatic stress disorder (PTSD) symptoms following childbirth: an experimental study. Appl Nurs Res. 2016 Nov;32:227-232. doi: 10.1016/j.apnr.2016.07.013. Epub 2016 Jul 30.

    PubMed 27969033

Questions about this trial

What is this clinical trial studying?

A study testing Prenatal Education Program Based on the Indivisible Self Model and The needs-based prenatal education program in people with Prenatal Education Program and Indivisible Self Model, run by Mersin University.

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 14 inclusion and 15 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gözde Gökçe İsbir (+905057782319, gozdegokce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychological Well-Being Scale (time frame: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07699900, which also lists 2 linked publications.

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 14 Jul 2026.

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