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IRCT20220123053802N3 IRCT 2026-07-08 National Institute for Medical Research Development Islamic Republic of Iran Design, Implementation, and Evaluation of a Comprehensive Fear-of-Childbirth Management Program Design, Implementation, and Evaluation of a Comprehensive Fear-of-Childbirth Management Program with an Interprofessional Approach 2026-09-23 anticipated 60 Recruiting https://irct.ir/trial/91323 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants will be randomly allocated to either the intervention or the control group in a 1:1 ratio using computer-generated block randomization with variable block sizes of 4 and 6. The random allocation sequence will be generated by an independent researcher who is not involved in participant recruitment or outcome assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE), which will be opened only after participant enrollment, Blinding description: Due to the educational and counseling nature of the intervention, blinding of participants, care providers, and investigators is not feasible. However, the outcome assessor and data analyst will remain blinded to group allocation throughout the study. Participants will be identified using unique codes, and group allocation information will not be disclosed to the outcome assessor or the data analyst until completion of the primary data analysis. This procedure is intended to minimize assessment and analysis bias. N/A fear of childbirth. Intervention 1: Intervention group: Receipt of prenatal care based on a comprehensive intervention package including individual and group education, midwifery counseling, peer education, breathing and relaxation exercises, guided hospital visits, couple sessions, religious and spiritual content, and use of a mobile application, from 28–30 weeks of gestation until childbirth. Intervention 2: Control group: Participants will receive routine antenatal care according to the national prenatal care guidelines of the Ministry of Health and Medical Education, without receiving the comprehensive Fear of Childbirth management program or the educational mobile application. Yes - There is a plan to make this available What will be shared: Publishable in the field of Midwifery When: Will be shared after completion of the study. To whom: Will be shared with researchers working in academic and scientific institutions after completion of the study. Conditions: Will be shared with researchers working in academic and scientific institutions after completion of the study. Where to obtain: After completion of the study, email addresses will be shared with applicants upon request. How to obtain: After completion of the study, applicants may request access to the files by contacting the provided email address. Comments:
public Soheila mohamadirizi
School of Nursing and Midwifery, Isfahan University of Medical Sciences Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7500 Smohamadirizi@nm.mui.ac.ir National Institute for Medical Research Development of the Islamic Republic of Iran (NIMAD) scientific Soheila mohamadirizi
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan City, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Smohamadirizi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) A fear of childbirth (FOC) score of 60 or higher (W-DEQ ≥60). no limit no limit Female High-risk pregnancy Definite medical indication for cesarean section. .History of diagnosed severe psychiatric disorders. Severe physical illness preventing participation in the educational intervention Unwillingness to participate in the study Behavior N/A Intervention group: Receipt of prenatal care based on a comprehensive intervention package including individual and group education, midwifery counseling, peer education, breathing and relaxation exercises, guided hospital visits, couple sessions, religious and spiritual content, and use of a mobile application, from 28–30 weeks of gestation until childbirth. Control group: Participants will receive routine antenatal care according to the national prenatal care guidelines of the Ministry of Health and Medical Education, without receiving the comprehensive Fear of Childbirth management program or the educational mobile application Fear of childbirth, childbirth self-efficacy, and maternal satisfaction. Timepoint: Before the intervention, two weeks after the intervention, and immediately after childbirth. Method of measurement: Questionnaire. Mode of delivery. Timepoint: postpartum. Method of measurement: questionnaire. National Institute for Medical Research Development Islamic Republic of Iran Approved 2026-05-19 National Institute for Medical Research Development Islamic Republic of Iran 13th Floor, Block A, Ministry of Health and Medical Education Headquarters, Simaye Iran Street, between South Falamak and Zarafshan Streets, Shahrak-e Gharb (Qods Town), Tehran, Iran. tehran Tehran Iran (Islamic Republic of)