NCT07436468

Brief Summary

This is a randomized controlled study was conducted to determine the effect of childbirth preparation and counseling training provided during pregnancy on adaptation to the pregnancy and childbirth process. This study with primiparous women school at a public hospital in Istanbul. A total of 110 pregnant women were divided into the Basic Education and Counseling Group (BECG; n=55) and the Basic Education Group (BEG; n=55). The BECG received childbirth preparation education plus counseling, while the BEG received only childbirth preparation education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 9, 2026

Last Update Submit

February 21, 2026

Conditions

Keywords

childbirth preparation trainingcounselingpregnancy adaptationfear of childbirthprenatal education

Outcome Measures

Primary Outcomes (1)

  • Educational level of pregnant women

    Pregnant women were asked whether their level of education had an impact on their participation in childbirth preparation classes. The educational levels of pregnant women were surveyed as primary school and below, high school, or college and above.

    In the first phase, both groups completed this questionnaire.

Secondary Outcomes (1)

  • Prenatal Self-Assessment Scale (PSAS)

    In the first phase, both groups completed the PSAS. In the third phase, participants who reached gestational week 37 were contacted, and PSAS were re-administered.

Other Outcomes (1)

  • Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A)

    In the first phase, both groups completed the W-DEQ-A. In the third phase, participants who reached gestational week 37 were contacted, and W-DEQ-A were re-administered.

Study Arms (2)

Basic Education and Counseling Group (BECG)

EXPERIMENTAL

The Basic Education and Counseling Group (BECG) participants, attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education was routinely provided at the hospital's pregnancy school, and participants who did not maintain attendance were excluded from the study. Ayrıca, the BECG, telephone numbers were collected, and were provided with a contact number for counseling services. BECG participants received telephone counseling 1-2 times monthly until gestational week 37.

Behavioral: Basic Education and Counseling

No intervention: Control Group

NO INTERVENTION

The Basic Education Group (BEG), participants attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. BEG, did not receive any intervention or consultancy services other than the education program.

Interventions

Description: The Basic Education and Counseling Group (BECG) participants, attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education was routinely provided at the hospital's pregnancy school, and participants who did not maintain attendance were excluded from the study. Ayrıca, the BECG, telephone numbers were collected, and were provided with a contact number for counseling services. BECG participants received telephone counseling 1-2 times monthly until gestational week 37.

Basic Education and Counseling Group (BECG)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years,
  • Primiparous status
  • Singleton pregnancy at 20-30 gestational weeks
  • Voluntary participation in the study.

You may not qualify if:

  • Diagnosis of high-risk pregnancy
  • Diagnosed fetal anomaly
  • Having conceived through infertility treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, 34051, Turkey (Türkiye)

Location

Related Publications (26)

  • 32. Uğuz Y, Karaçam Z. The effect of childbirth preparation education on women's delivery mode and views on childbirth. Adnan Menderes University Faculty of Health Sciences Journal. 2022;6(3).

    BACKGROUND
  • Halvorsen L, Nerum H, Sorlie T, Oian P. Does counsellor's attitude influence change in a request for a caesarean in women with fear of birth? Midwifery. 2010 Feb;26(1):45-52. doi: 10.1016/j.midw.2008.04.011. Epub 2008 Jul 14.

    PMID: 18621452BACKGROUND
  • 30. Buran G, Olgaç Z, Karaçam Z. The effect of childbirth preparation classes on women's delivery mode, fear, and experience: Systematic review. Life Sciences. 2020;15(4).

    BACKGROUND
  • 29. Esencan TY, Karabulut Ö, Yıldırım AD, et al. Delivery mode, first breastfeeding time, and skin-to-skin contact preferences of pregnant women receiving childbirth preparation education. Florence Nightingale Journal of Nursing. 2018;26(1):31-43.

    BACKGROUND
  • Soysal C, Ulas O, Isikalan MM, Biyik I, Tasci Y, Keskin N. The changes in fear of childbirth in pregnancy during and before the COVID-19 pandemic. Sci Rep. 2024 May 14;14(1):11067. doi: 10.1038/s41598-024-61307-9.

    PMID: 38744899BACKGROUND
  • Dai L, Shen Q, Redding SR, Ouyang YQ. Simulation-based childbirth education for Chinese primiparas: A pilot randomized controlled trial. Patient Educ Couns. 2021 Sep;104(9):2266-2274. doi: 10.1016/j.pec.2021.02.036. Epub 2021 Feb 19.

    PMID: 33663905BACKGROUND
  • 26. Subaşı B, Özcan H, Pekçetin S, et al. Effects of delivery education on childbirth anxiety and fear. Selçuk Medical Journal. 2013;29(4):165-167.

    BACKGROUND
  • 25. Barut S, Uçar T. The relationship between birth self-efficacy perception and fear of childbirth in pregnant women. Mersin University Journal of Health Sciences. 2018;11(2):107-115.

    BACKGROUND
  • 24. Akın B, Yeşil Y, Yücel U, et al. Effect of education given in prenatal education classes on pregnant women's fear of childbirth level. Life Sciences. 2018;13(2):11-20.

    BACKGROUND
  • Cankaya S, Simsek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021 Jul;30(6):818-829. doi: 10.1177/1054773820916984. Epub 2020 Apr 13.

    PMID: 32281410BACKGROUND
  • Doaltabadi Z, Amiri-Farahani L, Hasanpoor-Azghady SB. Implementation of Virtual and Face-to-Face Childbirth Preparation Training for the Spouses of the Primiparous Women to Reduce the Fear of Childbirth, Improve the Pregnancy Experience, and Enhance Mother- and Father-Infant Attachment: Protocol for a Quasiexperimental Clinical Trial. Obstet Gynecol Int. 2021 Apr 11;2021:6686934. doi: 10.1155/2021/6686934. eCollection 2021.

    PMID: 33936209BACKGROUND
  • Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5. doi: 10.1192/bjp.176.1.83.

    PMID: 10789333BACKGROUND
  • 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.

    PMID: 26656473BACKGROUND
  • 14. Yılmaz E. Effects of antenatal pregnancy education on birth and postpartum period [Doctoral dissertation]. Ankara: Gazi University Faculty of Health Sciences; 2019.

    BACKGROUND
  • 13. Yılmaz AN, Yüksekol ÖD, Baltacı N, et al. Examining the relationship between physiological complaints, quality of life, and pregnancy adaptation in pregnancy: A university hospital example. Mersin University Medical Faculty Lokman Hekim Journal. 2023;13(2):408-418.

    BACKGROUND
  • 12. Aksoy YE, Özentürk MG. Health behavior change stages of women in preconceptional period (transtheoretical model): Randomized Controlled Study. General Medical Journal. 2021;31(4):Article 4.

    BACKGROUND
  • 11. Başli M, Aksu H. Preconceptional counseling and care. Ege University Faculty of Nursing Journal. 2018;34(3):128-140.

    BACKGROUND
  • Athinaidou AM, Vounatsou E, Pappa I, Harizopoulou VC, Sarantaki A. Influence of Antenatal Education on Birth Outcomes: A Systematic Review Focusing on Primiparous Women. Cureus. 2024 Jul 14;16(7):e64508. doi: 10.7759/cureus.64508. eCollection 2024 Jul.

    PMID: 39139345BACKGROUND
  • 8. Güner PD, Bölükbaşı H, Tezcan E, et al. Factors associated with pregnancy and maternity adjustment of pregnant women in the prenatal period. Kafkas J Med Sci. 2021;11(1):45-51. doi:10.5505/kjms.2021.76768

    BACKGROUND
  • 7. Yılmaz SD, Beji NK. Stress coping, depression, and prenatal attachment levels of pregnant women and affecting factors. General Medical Journal. 2010;20(3):1-6.

    BACKGROUND
  • Barimani M, Forslund Frykedal K, Rosander M, Berlin A. Childbirth and parenting preparation in antenatal classes. Midwifery. 2018 Feb;57:1-7. doi: 10.1016/j.midw.2017.10.021. Epub 2017 Oct 31.

    PMID: 29128739BACKGROUND
  • 5. Cemek T. The Relationship Between Pregnant Women's Internet Use and Quality of Life [Master's Thesis]. Sivas: Sivas Cumhuriyet University Institute of Health Sciences; 2020.

    BACKGROUND
  • 4. Taşkın L. Birth and Women's Health Nursing. Ankara: Sistem Ofset Printing; 2016.

    BACKGROUND
  • 3. Özkan S, Keskinkılıç B, Sanisoğlu S, Özkan Altunay Z. Pregnancy Information Class Training Book. Ankara: Turkish Ministry of Health Public Health Institution Women's and Reproductive Health Department; 2014.

    BACKGROUND
  • 2. Karaçam Z, Akyüz EÖ. Supportive care during labor and the role of the midwife/nurse. Istanbul University Faculty of Nursing Journal. 2011;19(1):45-53.

    BACKGROUND
  • 1. Çoban A, Yanıkkerem U. Sleep quality and fatigue levels in pregnant women. Ege Medical Journal. 2010;49(2):87-94.

    BACKGROUND

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label)
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment The study included 110 pregnancy to pregnancy school affiliated with Health Sciences University Haseki Training and Research Hospital in Istanbul who consented to participate. Participants were randomized into two groups: the Basic Education and Counseling Group (BECG; n=55) and the Basic Education Group (BEG; n=55). All participants attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education participants who did not maintain attendance were excluded from the study. For the BECG, telephone numbers were collected, and participants were provided with a contact number for counseling services. In the second phase, BECG participants received telephone counseling 1-2 times monthly until gestational week 37. Questions asked during counseling were recorded in the Demographic Information Form. The BEG received no intervention during this phase.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 27, 2026

Study Start

March 1, 2024

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

We did not obtain permission from the participants to share their data with other researchers.

Locations