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IRCT20171007036615N16 IRCT 2025-11-18 Tabriz University of Medical Sciences Design and evaluation of an educational web application based on woman-centered care for childbirth preparation Design, development and evaluation of an educational web application based on woman-centered care for childbirth preparation in pregnant women 2027-01-11 anticipated 70 Pending https://irct.ir/trial/86456 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: One-half of the health centers will be selected, considering diverse geographical locations and socioeconomic levels. In total, five centers will be selected from different areas of Karaj (taking into account diversity in terms of socioeconomic status). A list of pregnant mothers is available in the 'Sib' Health Information System at the health centers. The researcher will attend the selected centers, prepare a list of potentially eligible individuals, and then contact them by phone. After assessing the inclusion and exclusion criteria, those who qualify will be given a brief explanation of the study's purpose. If they are willing to participate, they will be invited to an in-person session at a health center near their residence. Participants will be allocated to either the intervention or control group with a 1:1 ratio using block randomization, stratified by the number of previous births. A person not involved in the sampling will perform the allocation using RAS software with block sizes of 4 and 6. The allocation details will be written on paper and placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The envelopes will be opened in the order of the participants' entry into the study. The mother's name will be written on the selected envelope, and she will be informed of her assigned group. N/A Condition 1: childbirth preparation. Condition 2: fear of childbirth. Intervention 1: Intervention group: The designed web application will be installed on the smartphones of participants in the intervention group. Its content will be personalized so that, at the beginning, users must enter information such as gestational age and their symptoms. Based on these settings, each user will access the section of the app that contains information relevant to their pregnancy condition. The researcher will train participants in the intervention group on how to use the app so they can fully utilize its content over four weeks. The researcher will also provide online support and guidance during this period. Throughout the intervention, the researcher (student) will maintain contact with participants via phone calls and text messages to remind them to use the relevant content at each stage, and will share their contact information for any questions. To ensure thorough engagement with the app content, a limited set of relevant questions will be designed to be answered before and after each section. Intervention 2: Control group: They will receive routine care according to the national guidelines. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available.
public Dr.Esmat Mehrabi
South Shariati Street
tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 b.mehrabi@yahoo.com Tabriz University of Medical Sciences scientific Dr. Esmat Mehrabi
South Shariati Street
tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 b.mehrabi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age of 24 to 32 weeks Singleton pregnancy Literacy (ability to read and write) Ability to use a mobile application Not having a medical field education Possession of a smartphone 15 years 49 years Female Development of any pregnancy complications, such as preeclampsia. Bleeding and intrauterine fetal death. Multiple pregnancy Presence of chronic diseases or conditions that are induced or exacerbated by pregnancy, such as hypertension, cardiovascular diseases, diabetes, preeclampsia, etc. Indications for cesarean section, such as placenta previa, non-cephalic presentations, abnormal fetal heart rate patterns, etc. History of cesarean section or uterine surgery/scarring. Previous participation in physiological childbirth classes. Abnormal pregnancy conditions, such as polyhydramnios, oligohydramnios, or intrauterine growth restriction (IUGR). Prevention Prevention Intervention group: The designed web application will be installed on the smartphones of participants in the intervention group. Its content will be personalized so that, at the beginning, users must enter information such as gestational age and their symptoms. Based on these settings, each user will access the section of the app that contains information relevant to their pregnancy condition. The researcher will train participants in the intervention group on how to use the app so they can fully utilize its content over four weeks. The researcher will also provide online support and guidance during this period. Throughout the intervention, the researcher (student) will maintain contact with participants via phone calls and text messages to remind them to use the relevant content at each stage, and will share their contact information for any questions. To ensure thorough engagement with the app content, a limited set of relevant questions will be designed to be answered before and after each section. Control group: They will receive routine care according to the national guidelines. Childbirth preparation score. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Childbirth Readiness Scale(CRS). Fear of childbirth score. Timepoint: Before the intervention and 4 weeks after the intervention and 24 hours after delivery. Method of measurement: Wijma delivery expectancy/experience questionnaire. Childbirth experience score. Timepoint: 24hours after delivery. Method of measurement: Childbirth Experiences (CEQ-2.0) 2.0 Questionnaire version. Child Birth Self Efficacy score. Timepoint: Before the intervention and 24 hours after delivery. Method of measurement: Child Birth Self Efficacy questionnaire. Postpartum depression literacy score. Timepoint: Before the intervention and 4 weeks after the intervent. Method of measurement: Postpartum depression literacy Scale (PoDLiS). Frequency of mode of delivery. Timepoint: 24 hours after delivery. Method of measurement: Frequency of mode of delivery check list. Tabriz University of Medical Sciences Approved 2025-09-08 Research Ethics Committees of Tabriz University of Medical Science South Shariati Street, Faculty of Nursing and Midwifery, Tabriz tabriz East Azarbaijan Iran (Islamic Republic of)