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2 2025-02-13, 1403/11/25 334953
1 2024-10-18, 1403/07/27 317742
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  • Protocol summary

    تعیین تاثیر طراحی، اجرا و ارزیابی برنامه قصد به فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    تعیین تاثیر طراحی، اجرا و ارزشیابی برنامه قصد به فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    The pre-test involves women completing a self-reported questionnaire via an internal messaging network. The educational intervention includes at least four sessions: three sessions (45-60 minutes each, twice a week) for women at the Comprehensive Health Center and one session for husbands. These sessions, led by students under professor supervision, are based on pre-test results and interviews, following the Multi-Theory Model. Participants will receive updates, materials, and session reminders via the messaging network and SMS, with opportunities to ask questions through voice or private chat.
    The pre-test involves women completing a self-reported questionnaire via an internal messaging network. The educational intervention includes at least four sessions: (three sessions, 45-60 minutes each, twice a week for women at the Comprehensive Health Center and a joint session with their husbands.) These sessions, led by Ph.D student under professor supervision, are based on pre-test results and interviews, following the Multi-Theory Model. Participants will receive updates, materials, and session reminders via the messaging network and SMS, with opportunities to ask questions through voice or private chat.
    جهت شرکت در پیش آزمون، لینک پرسشنامه از طریق شبکه پیام¬رسان مجاز داخلی در اختیار کلیه زنان شرکت¬کننده قرار خواهد گرفت و توسط آنها به صورت خودگزارش¬دهی تکمیل می¬شود. مداخله آموزشی شامل حداقل 4 جلسه ، (شامل سه جلسه 45 - 60 دقیقه¬ای به صورت حضوری برای زنان دو بار در هفته در مرکز جامع سلامت و یک جلسه برای همسران)، توسط دانشجو و تحت نظر اساتید محترم راهنما بر اساس اطلاعات به دست آمده از بررسی نتایج مصاحبه¬ها و پیش¬آزمون و مبتنی بر سازه¬های مدل چندنظریه¬ای؛ برگزار خواهد شد. در شبکه پیام رسان داخلی علاوه بر اطلاع رسانی جلسات و به اشتراک¬گذاری مواد آموزشی، امکان پرسش و پاسخ از طریق ویس و چت خصوصی با پژوهشگر برقرار خواهد شد. تکالیف خانگی هر جلسه از طریق پیامک به افراد یادآوری می¬شود.
    جهت شرکت در پیش آزمون، لینک پرسشنامه از طریق شبکه پیام¬رسان مجاز داخلی در اختیار کلیه زنان شرکت¬کننده قرار خواهد گرفت و توسط آنها به صورت خودگزارش¬دهی تکمیل می¬شود. مداخله آموزشی شامل حداقل 4 جلسه ، (شامل سه جلسه 45 - 60 دقیقه¬ای به صورت حضوری برای زنان دو بار در هفته در مرکز جامع سلامت و یک جلسه به صورت مشترک با همسرانشان). جلسات توسط دانشجو ی دکتری و تحت نظر اساتید محترم راهنما بر اساس اطلاعات به دست آمده از بررسی نتایج مصاحبه¬ها و پیش¬آزمون و مبتنی بر سازه¬های مدل چندنظریه¬ای؛ برگزار خواهد شد. در شبکه پیام رسان داخلی علاوه بر اطلاع رسانی جلسات و به اشتراک¬گذاری مواد آموزشی، امکان پرسش و پاسخ از طریق ویس و چت خصوصی با پژوهشگر برقرار خواهد شد. تکالیف خانگی هر جلسه از طریق پیامک به افراد یادآوری می¬شود.
    Inclusion criteria: Be literate in reading and writing and reproductive age; Not planning pregnancy before the study; First marriage of the woman; Has one or two children; Shares a bed with her husband; At least 18 months since the previous pregnancy; Access to cell phones and virtual social networks; No medical contraindications for pregnancy; The only wife of her husband
    Inclusion criteria: Be literate in reading and writing and reproductive age; Not planning pregnancy before the study; First marriage of the woman; Has one child; having an active sexual and marital relationship; At least 18 months since the previous pregnancy; Access to cell phones and virtual social networks; No medical contraindications for pregnancy; The only wife of her husband
    شرایط ورود: دارای سواد خواندن و نوشتن و در سن باروری باشند، عدم قصد به بارداری قبل از شروع مطالعه، ازدواج اول خانم باشد، دارای یک فرزند یا دو فرزند باشد، دارای بستر مشترک با همسرش باشد، حداقل 18 ماه از بارداری قبلی اش گذشته باشد، دسترسی به تلفن همراه و شبکه های اجتماعی مجازی داشته باشد، شرکت‌‌کنندگان منع پزشکی برای بارداری نداشته باشند، تنها همسر شوهرش باشد. شرایط خروج: وقوع بارداری (در حین و قبل از مداخله)، عدم تمایل فرد یا همسرش جهت ادامه مشارکت در طرح.
    شرایط ورود: دارای سواد خواندن و نوشتن و در سن باروری باشند، عدم قصد به بارداری قبل از شروع مطالعه، ازدواج اول خانم باشد، دارای یک فرزند باشد، داشتن روابط جنسی و زناشویی فعال، حداقل 18 ماه از بارداری قبلی اش گذشته باشد، دسترسی به تلفن همراه و شبکه های اجتماعی مجازی داشته باشد، شرکت‌‌کنندگان منع پزشکی برای بارداری نداشته باشند، تنها همسر شوهرش باشد. شرایط خروج: وقوع بارداری (در حین و قبل از مداخله)، عدم تمایل فرد یا همسرش جهت ادامه مشارکت در طرح.
    The research population consists of women of reproductive age with one or two children who refer to comprehensive health centers in Yazd. The intervention consists of at least 4 sessions and the control group receives routine care at the health center
    The research population consists of women of reproductive age with one child who refer to comprehensive health centers in Yazd. The intervention consists of at least 4 sessions, and the control group receives routine care at the health center
    جامعه پژوهش، زنان سنین باروری دارای یک و دو فرزند مراجعه کننده به مراکز جامع سلامت شهر یزد می¬باشند.مداخله شامل حداقل 4 جلسه است و گروه کنترل مراقبت روتین مرکز بهداشت را دریافت میکنند
    جامعه پژوهش، زنان سنین باروری دارای یک فرزند مراجعه کننده به مراکز جامع سلامت شهر یزد می¬باشند.مداخله شامل حداقل 4 جلسه است و گروه کنترل مراقبت روتین مرکز بهداشت را دریافت میکنند
  • General information

    2025-02-19, 1403/12/01
    2025-04-09, 1404/01/20
    2025-05-22, 1404/03/01
    2025-07-23, 1404/05/01
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    -Modify "assess" to "evaluation" in the title. -Renaming one of the Inclusion criteria for entering the study from "To have a common bed with her husband" to "having an active sexual and marital relationship." -Insert the full name of the research committee, the Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd. - Change the target group from "Women with one and two children" to "Women with one child" - Modify the overall aim of the study to "Determine the effect of the childbearing intention program based on a multi-theory model in women of reproductive age referring to comprehensive health centers in Yazd city
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    -اصلاح کلمه ارزیابی به "ارزشیابی" در عنوان. - اصلاح یکی از متغیرهای ورود به مطالعه از "دارای بستر مشترک با همسرش باشد" به "داشتن روابط جنسی و زناشویی فعال". -وارد کردن اسم کامل کمیته تحقیقات کمیته اخلاق دانشگاه علوم پزشکی شهید صدوقی یزد. - تغییر گروه هدف از "زنان دارای یک و دو فرزند"به "زنان دارای یک فرزند" - اصلاح هدف کلی مطالعه به "تعیین تاثیر برنامه قصد فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد"
    ارزیابی برنامه قصد فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    ارزشیابی برنامه قصد فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    طراحی، اجرا و ارزیابی برنامه قصد فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    طراحی، اجرا و ارزشیابی برنامه قصد فرزندآوری براساس مدل چندنظریه¬ای در زنان سنین باروری مراجعه کننده به مراکز جامع سلامت شهر یزد
    Be literate in reading and writing.
    Be of reproductive age.
    Not intending to get pregnant before starting the study
    Be The first marriage of the woman
    have one or two children
    To have a common bed with her husband
    At least 18 months have passed since her previous pregnancy
    Access cell phones and virtual social networks
    Participants do not have medical contraindications for pregnancy (class 4 heart disease, patients using Teratogenic drugs for epilepsy or rheumatoid arthritis, and malignancies).
    Be the only wife of her husband.
    Be literate in reading and writing.
    Be of reproductive age.
    Not intending to get pregnant before starting the study
    Be The first marriage of the woman
    At least 18 months have passed since her previous pregnancy
    Access cell phones and virtual social networks
    Participants do not have medical contraindications for pregnancy (class 4 heart disease, patients using Teratogenic drugs for epilepsy or rheumatoid arthritis, and malignancies).
    Be the only wife of her husband.
    having an active sexual and marital relationship
    have one children
    دارای سواد خواندن و نوشتن باشند
    در سن باروری باشند
    عدم قصد به بارداری قبل از شروع مطالعه
    ازدواج اول خانم باشد
    دارای یک فرزند یا دو فرزند باشد
    دارای بستر مشترک با همسرش باشد
    حداقل 18 ماه از بارداری قبلی اش گذشته باشد
    دسترسی به تلفن همراه و شبکه های اجتماعی مجازی داشته باشد
    شرکت‌‌کنندگان منع پزشکی برای بارداری نداشته باشند (بیماریهای قلبی کلاس 4، بیمارانی که از داروهای تراتوژنیک برای صرع یا آرتریت روماتوئید استفاده می کنند و بدخیمی ها)
    تنها همسر شوهرش باشد
    دارای سواد خواندن و نوشتن باشند
    در سن باروری باشند
    عدم قصد به بارداری قبل از شروع مطالعه
    ازدواج اول خانم باشد
    حداقل 18 ماه از بارداری قبلی اش گذشته باشد
    دسترسی به تلفن همراه و شبکه های اجتماعی مجازی داشته باشد
    شرکت‌‌کنندگان منع پزشکی برای بارداری نداشته باشند (بیماریهای قلبی کلاس 4، بیمارانی که از داروهای تراتوژنیک برای صرع یا آرتریت روماتوئید استفاده می کنند و بدخیمی ها)
    تنها همسر شوهرش باشد
    داشتن روابط جنسی و زناشویی فعال
    دارای یک فرزند باشند
  • Intervention groups

    #1
    Intervention Group: To participate in the pre-test, the questionnaire link will be provided to all participating women via the authorized internal messaging network, where they will complete it in a self-reported format. The educational intervention will consist of at least four sessions (including three 45-60 minute in-person sessions for women, held twice a week and one session for husbands). These sessions will be conducted by students under the supervision of esteemed professors and will involve lectures, group discussions, educational videos, pamphlets, recommendations of educational books, and training based on insights from pre-test results and interviews, aligned with the structures of the Multi-Theory Model (MTM). The topics will cover:• Having children• The importance and position of children from the Islamic perspective and Quranic teachings• Benefits of having children• The ideal age for having children• The drawbacks of having few or only one child• Strategies to address challenges related to raising and caring for childrenIf necessary, based on pre-test results and the research team's judgment, the number of sessions will be increased. Through the internal messaging network, participants will receive updates on meetings and educational materials, and they will have the opportunity to ask questions via voice or private chat with the researcher. Session assignments will also be sent via SMS as reminders. Since the participation and support of husbands are crucial for having children, husbands will also receive training and counseling on the significance of childbearing, the appropriate timing and age, and additional related topics. The spouses of the participants in the intervention group will be invited to the Yazd Municipality Cultural Center, where they will receive necessary training during a group session conducted by experts trusted and approved by them.
    Intervention Group: To participate in the pre-test, the questionnaire link will be provided to all participating women via the authorized internal messaging network, where they will complete it in a self-reported format. The educational intervention will consist of at least four sessions (including three 45-60 minute in-person sessions for women, held twice a week, and a joint session with their husbands). These sessions will be conducted by students under the supervision of esteemed professors and will involve lectures, group discussions, educational videos, pamphlets, recommendations of educational books, and training based on insights from pre-test results and interviews, aligned with the structures of the Multi-Theory Model (MTM). The topics will cover:• Having children• The importance and position of children from the Islamic perspective and Quranic teachings• Benefits of having children• The ideal age for having children• The drawbacks of having few or only one child• Strategies to address challenges related to raising and caring for childrenIf necessary, based on pre-test results and the research team's judgment, the number of sessions will be increased. Through the internal messaging network, participants will receive updates on meetings and educational materials, and they will have the opportunity to ask questions via voice or private chat with the researcher. Session assignments will also be sent via SMS as reminders. Since the participation and support of husbands are crucial for having children, husbands will also receive training and counseling on the significance of childbearing, the appropriate timing and age, and additional related topics. A joint session with spouses (in the intervention group) will be invited at the Yazd Municipality Cultural Center, where they will receive necessary training during a group session conducted by experts trusted and approved by them.
    گروه مداخله: جهت شرکت در پیش آزمون، لینک پرسشنامه از طریق شبکه پیام¬رسان مجاز داخلی در اختیار کلیه زنان شرکت¬کننده قرار خواهد گرفت و توسط آنها به صورت خودگزارش¬دهی تکمیل می¬شود. مداخله آموزشی شامل حداقل 4 جلسه ، (شامل سه جلسه 45 - 60 دقیقه¬ای به صورت حضوری برای زنان دو بار در هفته و یک جلسه برای همسران)، توسط دانشجو و تحت نظر اساتید محترم راهنما به صورت سخنرانی، بحث گروهی، فیلم آموزشی، ارائه پمفلت، معرفی کتاب آموزشی، آموزش و هم¬اندیشی بر اساس اطلاعات به دست آمده از بررسی نتایج مصاحبه¬ها و پیش¬آزمون و مبتنی بر سازه¬های مدل چندنظریه¬ای؛ در مورد فرزندآوری، اهمیت و جایگاه فرزند از منظر دین مبین اسلام و آیات قرآن، فواید فرزندآوری، سن مناسب فرزندآوری، معایب کم فرزندی و تک فرزندی و راهکارهای مقابله با مشکلات مربوط به پرورش و نگهداری فرزند برگزار خواهد شد. در صورت لزوم بر اساس مطالعه آزمون پیش آزمون و نظر تیم تحقیق، تعداد جلسات آموزشی افزایش خواهد یافت. در شبکه پیام رسان داخلی علاوه بر اطلاع رسانی جلسات و به اشتراک¬گذاری مواد آموزشی، امکان پرسش و پاسخ از طریق ویس و چت خصوصی با پژوهشگر برقرار خواهد شد. تکالیف خانگی هر جلسه از طریق پیامک به افراد یادآوری می¬شود.چون مشارکت و حمایت شوهر از همسرش جهت فرزندآوری مهم است، شوهران شرکت¬کنندگان نیز تحت آموزش و مشاوره در مورد فرزندآوری، اهمیت زمان و سن مناسب آن و سایر اطلاعات تکمیلی قرار خواهند گرفت. بدین صورت که از همسران مشارکت¬کنندگان (گروه مداخله) در فرهنگسرای شهرداری یزد دعوت به عمل آمده و توسط چند متخصص مورد اعتماد و مورد تایید آنها، طی یک جلسه گروهی آموزشهای لازم را دریافت خواهند نمود.
    گروه مداخله: جهت شرکت در پیش آزمون، لینک پرسشنامه از طریق شبکه پیام¬رسان مجاز داخلی در اختیار کلیه زنان شرکت¬کننده قرار خواهد گرفت و توسط آنها به صورت خودگزارش¬دهی تکمیل می¬شود. مداخله آموزشی شامل حداقل 4 جلسه ، (شامل سه جلسه 45 - 60 دقیقه¬ای به صورت حضوری برای زنان دو بار در هفته و یک جلسه مشترک با همسرانشان)، توسط دانشجو و تحت نظر اساتید محترم راهنما به صورت سخنرانی، بحث گروهی، فیلم آموزشی، ارائه پمفلت، معرفی کتاب آموزشی، آموزش و هم¬اندیشی بر اساس اطلاعات به دست آمده از بررسی نتایج مصاحبه¬ها و پیش¬آزمون و مبتنی بر سازه¬های مدل چندنظریه¬ای؛ در مورد فرزندآوری، اهمیت و جایگاه فرزند از منظر دین مبین اسلام و آیات قرآن، فواید فرزندآوری، سن مناسب فرزندآوری، معایب کم فرزندی و تک فرزندی و راهکارهای مقابله با مشکلات مربوط به پرورش و نگهداری فرزند برگزار خواهد شد. در صورت لزوم بر اساس مطالعه آزمون پیش آزمون و نظر تیم تحقیق، تعداد جلسات آموزشی افزایش خواهد یافت. در شبکه پیام رسان داخلی علاوه بر اطلاع رسانی جلسات و به اشتراک¬گذاری مواد آموزشی، امکان پرسش و پاسخ از طریق ویس و چت خصوصی با پژوهشگر برقرار خواهد شد. تکالیف خانگی هر جلسه از طریق پیامک به افراد یادآوری می¬شود.چون مشارکت و حمایت شوهر از همسرش جهت فرزندآوری مهم است، شوهران شرکت¬کنندگان نیز تحت آموزش و مشاوره در مورد فرزندآوری، اهمیت زمان و سن مناسب آن و سایر اطلاعات تکمیلی قرار خواهند گرفت. بدین صورت که از همسران مشارکت¬کنندگان به صورت مشترک (گروه مداخله) در فرهنگسرای شهرداری یزد دعوت به عمل آمده و توسط چند متخصص مورد اعتماد و مورد تایید آنها، طی یک جلسه گروهی آموزشهای لازم را دریافت خواهند نمود.
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر امین صالحی ابرقویی
    Full name of responsible person - Persian: Dr. Amin Salehi Abargoui
    Street address - English: Vice-chancellor for Research of Yazd University of Medical Sciences ., Imam Hossein Square,. Yazd
    Street address - Persian: یزد، میدان امام حسین(ع)، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۵۴۵۷۳۴۵
    Phone: +98 35 3834 4099
    Fax:
    Email: arianmokhtari2@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکترامیرهوشنگ مهرپرور
    Full name of responsible person - Persian: Dr. Amir Hoshang Mehrparvar
    Street address - English: Vice-chancellor for Research of Yazd University of Medical Sciences ., Imam Hossein Square,. Yazd
    Street address - Persian: یزد، میدان امام حسین(ع)، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۵۴۵۷۳۴۵
    Phone: +98 35 3834 4099
    Fax:
    Email: arianmokhtari2@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effect of Design, implementation, and evaluation of childbearing intention program based on multi -theory model in women of reproductive age referring to comprehensive health centers;Yazd
Design
A clinical trial with a control group, parallel groups, randomized, on 100 patients( 50 people in each group). Random Allocation software will be used for randomization.
Settings and conduct
The pre-test involves women completing a self-reported questionnaire via an internal messaging network. The educational intervention includes at least four sessions: (three sessions, 45-60 minutes each, twice a week for women at the Comprehensive Health Center and a joint session with their husbands.) These sessions, led by Ph.D student under professor supervision, are based on pre-test results and interviews, following the Multi-Theory Model. Participants will receive updates, materials, and session reminders via the messaging network and SMS, with opportunities to ask questions through voice or private chat.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Be literate in reading and writing and reproductive age; Not planning pregnancy before the study; First marriage of the woman; Has one child; having an active sexual and marital relationship; At least 18 months since the previous pregnancy; Access to cell phones and virtual social networks; No medical contraindications for pregnancy; The only wife of her husband
Intervention groups
The research population consists of women of reproductive age with one child who refer to comprehensive health centers in Yazd. The intervention consists of at least 4 sessions, and the control group receives routine care at the health center
Main outcome variables
Changing the behavior of pregnancy intention and the mean scores of the constructs of the beginning and Sustaining pregnancy behavior change.

General information

Reason for update
-Modify "assess" to "evaluation" in the title. -Renaming one of the Inclusion criteria for entering the study from "To have a common bed with her husband" to "having an active sexual and marital relationship." -Insert the full name of the research committee, the Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd. - Change the target group from "Women with one and two children" to "Women with one child" - Modify the overall aim of the study to "Determine the effect of the childbearing intention program based on a multi-theory model in women of reproductive age referring to comprehensive health centers in Yazd city
Acronym
IRCT registration information
IRCT registration number: IRCT20170802035446N3
Registration date: 2024-10-18, 1403/07/27
Registration timing: prospective

Last update: 2025-04-02, 1404/01/13
Update count: 1
Registration date
2024-10-18, 1403/07/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3252 6897
Email address
arianmokhtari2@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of childbearing intention program based on Multi -theory model in women of reproductive age referring to comprehensive health centers in Yazd
Public title
evaluation of childbearing intention program based on Multi - theory model in women of reproductive age referring to comprehensive health centers in Yazd
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate in reading and writing. Be of reproductive age. Not intending to get pregnant before starting the study Be The first marriage of the woman At least 18 months have passed since her previous pregnancy Access cell phones and virtual social networks Participants do not have medical contraindications for pregnancy (class 4 heart disease, patients using Teratogenic drugs for epilepsy or rheumatoid arthritis, and malignancies). Be the only wife of her husband. having an active sexual and marital relationship have one children
Exclusion criteria:
Occurrence of pregnancy (during and before the intervention) The unwillingness of the wife or her husband to continue participating in the plan
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
At first, for the greater diversity of participants, among the 23 comprehensive health centers of Yazd city, in each of the north, south, east, and west parts of Yazd city, a total of four comprehensive health centers will be selected by cluster sampling method and Simple randomization, two centers will be selected for intervention and two centers for control. Sampling centers for the intervention and control groups are selected in such a way that they are similar in economic, social, and cultural terms. In the intervention phase, 100 women will be included in the study, using random allocation software, in a simple random manner. They are divided into two intervention groups (50 participants) and control group (50 participants).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study will be of a combined exploratory type that will be conducted in three phases and stages.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Shahid Sadoughi University of Medical Sciences in Yazd, Iran.
Street address
Imam Hossein (AS) square., Vice-chancellor for Research of Yazd University of Medical Sciences., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.SSU.SPH.REC.1403.069

Health conditions studied

1

Description of health condition studied
Childbearing behavior
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Changing the behavior of pregnancy intention. Behavioral intention means starting the behavior of having children, performing pre-pregnancy care behaviors in the health center by completing the pre-pregnancy care form, starting to take folic acid, and not using contraceptive methods.
Timepoint
Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
Method of measurement
Questionnaire

2

Description
Change in the mean scores of the constructs of the beginning of pregnancy behavior change (participatory dialogue, behavioral confidence, change in the physical environment)
Timepoint
Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
Method of measurement
Questionnaire

3

Description
Change in the mean scores of the constructs of maintaining and Sustaining pregnancy behavior change (emotional transformation, change in the social environment, practicing for change)
Timepoint
Before the intervention based on the Multi-theory model in two groups. One month later and three months after the completion of the intervention based on the Multi-theory model in two groups. before, one month after, and three months after the completion of the intervention based on the multi-theoretical model in each group.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Pregnancy rate
Timepoint
Three, six, and nine months after the intervention based on the Multi-theory model l
Method of measurement
Phone interview

Intervention groups

1

Description
Intervention Group: To participate in the pre-test, the questionnaire link will be provided to all participating women via the authorized internal messaging network, where they will complete it in a self-reported format. The educational intervention will consist of at least four sessions (including three 45-60 minute in-person sessions for women, held twice a week, and a joint session with their husbands). These sessions will be conducted by students under the supervision of esteemed professors and will involve lectures, group discussions, educational videos, pamphlets, recommendations of educational books, and training based on insights from pre-test results and interviews, aligned with the structures of the Multi-Theory Model (MTM). The topics will cover:• Having children• The importance and position of children from the Islamic perspective and Quranic teachings• Benefits of having children• The ideal age for having children• The drawbacks of having few or only one child• Strategies to address challenges related to raising and caring for childrenIf necessary, based on pre-test results and the research team's judgment, the number of sessions will be increased. Through the internal messaging network, participants will receive updates on meetings and educational materials, and they will have the opportunity to ask questions via voice or private chat with the researcher. Session assignments will also be sent via SMS as reminders. Since the participation and support of husbands are crucial for having children, husbands will also receive training and counseling on the significance of childbearing, the appropriate timing and age, and additional related topics. A joint session with spouses (in the intervention group) will be invited at the Yazd Municipality Cultural Center, where they will receive necessary training during a group session conducted by experts trusted and approved by them.
Category
N/A

2

Description
Control Group: During this period, the control group will receive routine care from the comprehensive health center. All participating women in both groups will complete the questionnaire again one month and three months after the intervention. Pregnancy occurrence will be followed up by telephone calls to the women (in both groups) at three, six, and nine months after the intervention. Upon completing the follow-ups, and per ethical principles, the educational materials and package will be made available to the women and their spouses in the control group through a virtual network, where their questions will be answered.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers (Rahmat Abad and Farabi), Shahid Dashti Blvd, Yazd; comprehensive healt
Full name of responsible person
Tayebeh Mokhtari Sorkhani
Street address
Mohabbateh Alley, Imam Reza Street, Modares Blvd., Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۴۵۷۳۴۵
Phone
+98 35 3834 4099
Email
arianmokhtari2@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
دکترامیرهوشنگ مهرپرور
Street address
Vice-chancellor for Research of Yazd University of Medical Sciences ., Imam Hossein Square,. Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۴۵۷۳۴۵
Phone
+98 35 3834 4099
Email
arianmokhtari2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tayebeh Mokhtari Sorkhani
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mohabbateh Alley., Imam Reza Street., Modares Blvd., Yazd
City
یزد
Province
Yazd
Postal code
۸۹۱۵۴۵۷۳۴۵
Phone
+98 35 3834 4099
Email
arianmokhtari2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeid Mazloomi Mahmodabad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alem Square., Faculty of Health., Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Phone
+98 35 3820 9100
Email
Mazloomy.mm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tayebeh Mokhtari Sorkhani
Position
Phd Candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mohabbateh Alley., Imam Reza Street., Modares Blvd., Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۴۵۷۳۴۵
Phone
+98 35 3834 4099
Email
arianmokhtari2@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after making people unidentifiable, for example, in a qualitative study, how to code and themes obtained, and the psychometrics of the final questionnaire and the result of the intervention phase.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and policy makers of the Ministry of Health, Treatment and Medical Education
Under which criteria data/document could be used
The results of the study can be used in other provinces with the permission of the researchers
From where data/document is obtainable
Tayebeh Mokhtari Sorkhani 00989138417584 arianmokhtari2@gmail.com
What processes are involved for a request to access data/document
After receiving the email, the files will be sent in less than a week
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