Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:12 AM
Study NCT ID:
NCT07436468
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Childbirth Preparation and Counseling Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.\n\nFor 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A)', 'timeFrame': '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.', 'description': "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."}], 'primaryOutcomes': [{'measure': 'Educational level of pregnant women', 'timeFrame': 'In the first phase, both groups completed this questionnaire.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Prenatal Self-Assessment Scale (PSAS)', 'timeFrame': '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.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['childbirth preparation training', 'counseling', 'pregnancy adaptation', 'fear of childbirth', 'prenatal education'], 'conditions': ['Childbirth Preparation Training', 'Counseling']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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)."}, {'pmid': '18621452', 'type': 'BACKGROUND', 'citation': "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."}, {'type': 'BACKGROUND', 'citation': "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)."}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38744899', 'type': 'BACKGROUND', 'citation': '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': '33663905', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '32281410', 'type': 'BACKGROUND', 'citation': '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': '33936209', 'type': 'BACKGROUND', 'citation': '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': '10789333', 'type': 'BACKGROUND', 'citation': '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': '26656473', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '14. Yılmaz E. Effects of antenatal pregnancy education on birth and postpartum period [Doctoral dissertation]. Ankara: Gazi University Faculty of Health Sciences; 2019.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '11. Başli M, Aksu H. Preconceptional counseling and care. Ege University Faculty of Nursing Journal. 2018;34(3):128-140.'}, {'pmid': '39139345', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29128739', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': "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."}, {'type': 'BACKGROUND', 'citation': "4. Taşkın L. Birth and Women's Health Nursing. Ankara: Sistem Ofset Printing; 2016."}, {'type': 'BACKGROUND', 'citation': "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."}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '1. Çoban A, Yanıkkerem U. Sleep quality and fatigue levels in pregnant women. Ege Medical Journal. 2010;49(2):87-94.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': "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.\n\nResearch Hypotheses H1: Childbirth preparation education has an effect on pregnancy adaptation. H2: Childbirth preparation education and counseling have an effect on pregnancy adaptation.\n\nH3: Educational status has an effect on participation in childbirth preparation education.\n\nH4: Childbirth preparation education has an effect on reducing fear of childbirth.\n\nH5: Childbirth preparation education and counseling have an effect on reducing fear of childbirth.\n\nImplementation:\n\nEligible 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.\n\nFor 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.\n\nChildbirth Preparation Education Program\n\n1. 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\n2. 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\n3. 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\n4. 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"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years,\n* Primiparous status\n* Singleton pregnancy at 20-30 gestational weeks\n* Voluntary participation in the study.\n\nExclusion Criteria:\n\n* Diagnosis of high-risk pregnancy\n* Diagnosed fetal anomaly\n* Having conceived through infertility treatment'}, 'identificationModule': {'nctId': 'NCT07436468', 'briefTitle': 'Childbirth Preparation and Counseling Training', 'organization': {'class': 'OTHER', 'fullName': 'Biruni University'}, 'officialTitle': 'The Effect of Childbirth Preparation and Counseling Training During Pregnancy on Adaptation to Pregnancy and Childbirth', 'orgStudyIdInfo': {'id': '2023/83-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basic Education and Counseling Group (BECG)', '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.", 'interventionNames': ['Behavioral: Basic Education and Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention: Control Group', 'description': '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': [{'name': 'Basic Education and Counseling', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Basic Education and Counseling Group (BECG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34051', 'city': 'Istanbul', 'state': 'Zeytinburnu', 'country': 'Turkey (Türkiye)', 'facility': 'Biruni University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We did not obtain permission from the participants to share their data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biruni University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gulsen Cayir', 'investigatorAffiliation': 'Biruni University'}}}}