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Completed

NCT Number: NCT07436468

Childbirth Preparation and Counseling Training

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Zeytinburnu, 34051, Turkey (Türkiye)

About this study

This is a randomized controlled study. The research was carried out in at a public hospital in Istanbul. This study was conducted at the pregnancy school affiliated with Health Sciences University Haseki Training and Research Hospital in Istanbul, Turkey, between 01 March 2024 and 31 October 2024. The study population consisted of primiparous pregnant women between 20-30 gestational weeks who applied to the pregnancy school.

Research Hypotheses H1: Childbirth preparation education has an effect on pregnancy adaptation. H2: Childbirth preparation education and counseling have an effect on pregnancy adaptation.

H3: Educational status has an effect on participation in childbirth preparation education.

H4: Childbirth preparation education has an effect on reducing fear of childbirth.

H5: Childbirth preparation education and counseling have an effect on reducing fear of childbirth.

Implementation:

Eligible participants who consented were randomized into the BECG and BEG groups. In the first phase, both groups completed the Demographic Information Form, PSAS, and W-DEQ-A. 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 to both groups at the hospital's pregnancy school, and 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. In the third phase, participants who reached gestational week 37 were contacted, and the relevant sections of the Demographic Information Form, PSAS, and W-DEQ-A were re-administered.

Childbirth Preparation Education Program

  • nd SESSION: PREGNANCY AND NUTRITION Anatomy and function of reproductive organs Hormones Menstrual cycle Fertilization Ectopic pregnancy-twin pregnancy Changes that may occur in the body during pregnancy Smoking, alcohol, and drug use during pregnancy Clothing during pregnancy Working life during pregnancy Sexuality during pregnancy Nutrition during pregnancy Warning signs during pregnancy Travel during pregnancy Timing of pregnancy checkups Tetanus vaccination during pregnancy Blood type incompatibility Tests to be performed during pregnancy Emotional changes during pregnancy Growth and development of the baby in the womb Exercises to be performed during pregnancy
  • nd SESSION: BIRTH AND BREATHING EXERCISES Birth preparation plan Signs indicating the onset of labor What to expect when going to the hospital for birth Stages of labor Breathing techniques (practical) Pain management techniques used during birth (practical) Exercises to do during pregnancy and childbirth (hands-on) Massages (hands-on) Interventional births
  • nd SESSION: BREAST MİLK AND BREASTFEEDİNG TECHNİQUES - NEWBORN CARE Properties and benefits of breast milk Breastfeeding status worldwide and in Turkey Structure of the breasts Duration and reasons for breastfeeding Breastfeeding mechanism Breastfeeding technique (practical) Breastfeeding and medication use Breast care (practical) Factors that decrease and increase breast milk How to determine breast milk adequacy? Problems that may arise during breastfeeding and their solutions How to express and store breast milk (practical) Procedures performed on the newborn immediately after birth Newborn characteristics/appearance Problems seen in the newborn period Umbilical cord care (practical) Baby bath (practical) Baby clothing (practical) Baby's urine and stool Choosing baby diapers Diaper changing (practical) Nail cutting (practical) Newborn screening tests Hearing test Technique for measuring body temperature with a thermometer Sleeping positions (practical) Communicating with the baby Baby massage (practical) The baby's room Newborn baby safety Baby's registration procedures Well-child checkups Vaccinations
  • nd SESSION: POSTNATAL PERIOD AND FAMILY PLANNING Postnatal period Postpartum bleeding and abdominal massage (practical) When to go to the toilet and get up Rest First breastfeeding Postpartum hygiene, stitches Postpartum checkups Nutrition Medication use Sexuality Emotional changes Postpartum exercises (practical) Postpartum care after cesarean section Postpartum contraception

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Basic Education and Counseling

Behavioral

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.

Primary outcomes

  1. Educational level of pregnant women

    Time frame: In the first phase, both groups completed this questionnaire.

    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.

Secondary outcomes

  1. Prenatal Self-Assessment Scale (PSAS)

    Time frame: 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.

    PSAS was developed to measure adaptation to pregnancy and childbirth during the prenatal period. The scale is a structured assessment tool consisting of 79 items rated on a 4-point Likert format (4=does not describe at all, 3=somewhat describes, 2=partially describes, 1=very much describes). Forty-seven items are reverse-scored, and no cut-off point exists. The PSAS contains seven subscales: maternal-fetal health perception, acceptance of pregnancy, internalization of motherhood role, readiness for labor, fear of childbirth, relationship with mother, and relationship with spouse. Total scores range from 79-316, with lower scores indicating optimal maternal adaptation. In this study, the global Cronbach's α was 0.84, with subscale values ranging from 0.73-0.83.

Other outcomes

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

    Time frame: 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.

    W-DEQ-A was developed to measure women's fear of childbirth. Developed by Wijma and colleagues in 1998,15 the Turkish adaptation was performed by Körükcü and Kukulu.17 This 33-item instrument uses a 6-point Likert format (0-5 points). Total scores range from 0-165, with higher scores indicating increased childbirth anxiety. W-DEQ-A scores are classified into four categories: minimal anxiety (≤37), moderate anxiety (38-65), severe anxiety (66-84), and clinical-level anxiety (≥85). The original validation study reported Cronbach's α of 0.89; in the present study, this value was 0.94.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

The Effect of Childbirth Preparation and Counseling Training During Pregnancy on Adaptation to Pregnancy and Childbirth

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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