Investigating the effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers: A clinical trial study
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Protocol summary
A randomized controlled clinical trial, after meeting the study entry requirements (according to inclusion and exclusion criteria), each individual's hospital file number is considered a unique identifier.
This number is usually issued sequentially and non-repeatingly by the hospital system. So that the samples are placed in two intervention and control groups based on the hospital file number. Intervention group: participants with odd file numbers and control group: participants with even file numbers, phase 2 on 280 patients.
A controlled, parallel-group, randomized phase 2 clinical trial conducted on 280 patients. Eligible participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio.
A controlled, parallel-group, randomized controlledphase 2 clinical trial, after meeting the study entry requirements (according to inclusion and exclusion criteria), each individual's hospital file number is considered a unique identifier. This number is usually issued sequentially and non-repeatingly by the hospital system. So that the samples are placed in two intervention and control groups based on the hospital file number. Intervention group: participants with odd file numbers and control group: participants with even file numbers, phase 2 conducted on 280 patients. Eligible participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio.
کارآزمایی بالینی دارای گروه کنترل، تصادفی شده، پس از احراز شرایط ورود به مطالعه (طبق معیارهای شمول و عدم شمول)، شماره پرونده بیمارستانی هر فرد به عنوان شناسه منحصربه‌فرد در نظر گرفته می‌شود.
این شماره معمولاً به صورت متوالی و غیرتکراری توسط سیستم بیمارستان صادر می‌شود.به طوری که نمونه ها بر اساس شماره پرونده بیمارستانی در دو گروه مداخله و کنترل قرار می گیرند گروه مداخله: شرکت‌کنندگان با شماره پرونده فرد و گروه کنترل: شرکت‌کنندگان با شماره پرونده زوج، فاز 2 بر روی 280 بیمار.
کارآزمایی بالینی دارای گروه کنترل و گروه‌های موازی، تصادفی‌شده، فاز ۲، بر روی ۲۸۰ بیمار. شرکت‌کنندگان واجد شرایط به‌صورت فردی با استفاده از تصادفی‌سازی بلوکی با اندازه بلوک چهار نفره و نسبت تخصیص ۱:۱ به گروه مداخله یا کنترل تخصیص داده شدند.
کارآزمایی بالینی دارای گروه کنترل و گروه‌های موازی، تصادفی‌شده، پسفاز ۲، بر روی ۲۸۰ بیمار. شرکت‌کنندگان واجد شرایط به‌صورت فردی با استفاده از احراز شرایط ورود به مطالعه (طبق معیارهای شمولتصادفیسازی بلوکی با اندازه بلوک چهار نفره و عدم شمول)، شماره پرونده بیمارستانی هر فردنسبت تخصیص ۱:۱ به عنوان شناسه منحصربه‌فرد در نظر گرفته می‌شود. این شماره معمولاً به صورت متوالی و غیرتکراری توسط سیستم بیمارستان صادر می‌شود.به طوری که نمونه ها بر اساس شماره پرونده بیمارستانی در دو گروه مداخله ویا کنترل قرار می گیرند گروه مداخله: شرکت‌کنندگان با شماره پرونده فرد و گروه کنترل: شرکت‌کنندگان با شماره پرونده زوج، فاز 2 بر روی 280 بیمارتخصیص داده شدند.
General information
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The trial record is being updated to correct, complete, and clarify the information regarding the allocation of participants. In the previous version of the record, the participant allocation method was described as pseudorandom allocation based on the parity (even or odd) of the hospital record number. This description did not accurately and completely reflect the allocation method used in the conduct of the study. Therefore, the randomization-related information is being revised to accurately and transparently document the participant allocation procedure used in the trial.
Specifically, the “Randomization (investigator's opinion)” field is being changed from “Not randomized” to “Randomized,” and the “Randomization description” field is being revised to describe individual-level block randomization with a block size of four and a 1:1 allocation ratio. The formation of six possible allocation sequences and the random selection with replacement of 70 blocks to generate the allocation sequence for 280 participants are also documented. This update is intended to improve the accuracy and transparency of the trial record and to accurately reflect the allocation method used in the study.
The trial record is being updated to correct, complete, and clarify the information regarding the allocation of participants. In the previous version of the record, the participant allocation method was described as pseudorandom allocation based on the parity (even or odd) of the hospital record number. This description did not accurately and completely reflect the allocation method used in the conduct of the study. Therefore, the randomization-related information is being revised to accurately and transparently document the participant allocation procedure used in the trial. Specifically, the “Randomization (investigator's opinion)” field is being changed from “Not randomized” to “Randomized,” and the “Randomization description” field is being revised to describe individual-level block randomization with a block size of four and a 1:1 allocation ratio. The formation of six possible allocation sequences and the random selection with replacement of 70 blocks to generate the allocation sequence for 280 participants are also documented. This update is intended to improve the accuracy and transparency of the trial record and to accurately reflect the allocation method used in the study.
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این رکورد به منظور اصلاح، تکمیل و شفاف‌سازی اطلاعات مربوط به روش تخصیص شرکت‌کنندگان به‌روزرسانی می‌شود. در نسخه قبلی رکورد، روش تخصیص شرکت‌کنندگان به‌صورت شبه‌تصادفی بر اساس زوج یا فرد بودن شماره پرونده بیمارستانی ثبت شده بود که بیان دقیق و کاملی از روش تخصیص مورد استفاده در اجرای مطالعه نبوده است. بنابراین، اطلاعات مربوط به تصادفی‌سازی اصلاح می‌شود تا روش واقعی تخصیص شرکت‌کنندگان به‌طور دقیق و شفاف در رکورد کارآزمایی ثبت شود.
به‌طور اختصاصی، فیلد «Randomization (investigator's opinion)» از «Not randomized» به «Randomized» اصلاح می‌شود و در فیلد «Randomization description» روش تصادفی‌سازی بلوکی در سطح فردی، با اندازه بلوک چهار نفره و نسبت تخصیص ۱:۱، توضیح داده می‌شود. همچنین نحوه تشکیل شش توالی ممکن و انتخاب تصادفی ۷۰ بلوک با جایگذاری برای ایجاد توالی تخصیص ۲۸۰ شرکت‌کننده در این بخش ثبت می‌شود. این به‌روزرسانی با هدف افزایش دقت و شفافیت رکورد و انعکاس صحیح روش تخصیص مورد استفاده در مطالعه انجام می‌شود.
این رکورد به منظور اصلاح، تکمیل و شفاف‌سازی اطلاعات مربوط به روش تخصیص شرکت‌کنندگان به‌روزرسانی می‌شود. در نسخه قبلی رکورد، روش تخصیص شرکت‌کنندگان به‌صورت شبه‌تصادفی بر اساس زوج یا فرد بودن شماره پرونده بیمارستانی ثبت شده بود که بیان دقیق و کاملی از روش تخصیص مورد استفاده در اجرای مطالعه نبوده است. بنابراین، اطلاعات مربوط به تصادفی‌سازی اصلاح می‌شود تا روش واقعی تخصیص شرکت‌کنندگان به‌طور دقیق و شفاف در رکورد کارآزمایی ثبت شود. به‌طور اختصاصی، فیلد «Randomization (investigator's opinion)» از «Not randomized» به «Randomized» اصلاح می‌شود و در فیلد «Randomization description» روش تصادفی‌سازی بلوکی در سطح فردی، با اندازه بلوک چهار نفره و نسبت تخصیص ۱:۱، توضیح داده می‌شود. همچنین نحوه تشکیل شش توالی ممکن و انتخاب تصادفی ۷۰ بلوک با جایگذاری برای ایجاد توالی تخصیص ۲۸۰ شرکت‌کننده در این بخش ثبت می‌شود. این به‌روزرسانی با هدف افزایش دقت و شفافیت رکورد و انعکاس صحیح روش تخصیص مورد استفاده در مطالعه انجام می‌شود.
In this study, quasi-randomization was used based on whether the hospital file number is even or odd. This method is implemented as follows:
Patients are screened based on inclusion and exclusion criteria.
If eligible, their hospital file number is recorded as a unique identifier.
Checking whether the file number is even or odd
The hospital file number (e.g. 1400256) is checked:
If the last digit is an odd number (1, 3, 5, 7, 9): the patient is placed in the intervention group.
If the last digit is an even number (0, 2, 4, 6, 8): the patient is placed in the control group.
The group of each patient is saved in an Excel file or study registration system immediately after determination.
No special software or website is used for randomization.
Allocation is done manually and based on the even/odd rule.
Participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio. Six possible allocation sequences were formed, with each block containing two intervention and two control allocations in different sequences. Seventy blocks were randomly selected with replacement to generate the allocation sequence for the 280 participants. Participants were subsequently allocated sequentially to the intervention or control group according to the resulting randomization sequence. No stratified randomization was used. The randomization sequence was generated before participant allocation.
In this studyParticipants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio. Six possible allocation sequences were formed, quasi-with each block containing two intervention and two control allocations in different sequences. Seventy blocks were randomly selected with replacement to generate the allocation sequence for the 280 participants. Participants were subsequently allocated sequentially to the intervention or control group according to the resulting randomization sequence. No stratified randomization was used based on whether the hospital file number is even or odd. This method is implemented as follows: Patients are screened based on inclusion and exclusion criteria. If eligible, their hospital file number is recorded as a unique identifier. Checking whether the file number is even or odd The hospital file number (e.g. 1400256) is checked: If the last digit is an odd number (1, 3, 5, 7, 9): the patient is placed in the intervention group. If the last digit is an even number (0, 2, 4, 6, 8): the patient is placed in the control group. The group of each patient is saved in an Excel file or study registration system immediately after determinationrandomization sequence was generated before participant allocation. No special software or website is used for randomization. Allocation is done manually and based on the even/odd rule.
در این مطالعه از روش تخصیص شبه‌تصادفی (Quasi-randomization) بر اساس زوج یا فرد بودن شماره پرونده بیمارستانی استفاده شده است. این روش به شرح زیر اجرا می‌شود:
بیماران بر اساس معیارهای شمول و عدم شمول غربالگری می‌شوند.
در صورت واجد شرایط بودن، شماره پرونده بیمارستانی آنها به عنوان شناسه منحصربه‌فرد ثبت می‌شود.
بررسی زوج یا فرد بودن شماره پرونده
شماره پرونده بیمارستانی (مثلاً 1400256) بررسی می‌شود:
اگر رقم آخر شماره فرد بود (۱, ۳, ۵, ۷, ۹): بیمار در گروه مداخله قرار می‌گیرد.
اگر رقم آخر شماره زوج بود (۰, ۲, ۴, ۶, ۸): بیمار در گروه کنترل قرار می‌گیرد.
گروه هر بیمار بلافاصله پس از تعیین در فایل اکسل یا سیستم ثبت مطالعه ذخیره می‌شود.
از هیچ نرم‌افزار یا وب‌سایت خاصی برای تصادفی‌سازی استفاده نمی شود.
تخصیص به‌صورت دستی و بر اساس قاعده زوج/فرد انجام می‌شود.
در این مطالعه، شرکت‌کنندگان به‌صورت فردی و با استفاده از روش تصادفی‌سازی بلوکی با اندازه بلوک چهار نفره و نسبت تخصیص ۱:۱ به گروه مداخله یا کنترل تخصیص داده شدند. شش توالی تخصیص ممکن تشکیل شد که در هر بلوک شامل دو تخصیص به گروه مداخله و دو تخصیص به گروه کنترل بود و ترتیب تخصیص‌ها در توالی‌های مختلف متفاوت بود. سپس ۷۰ بلوک به‌صورت تصادفی و با جایگذاری انتخاب شد تا توالی تخصیص برای ۲۸۰ شرکت‌کننده ایجاد شود. شرکت‌کنندگان بر اساس توالی تصادفی حاصل به‌صورت متوالی به گروه مداخله یا کنترل تخصیص داده شدند. از تصادفی‌سازی لایه‌ای استفاده نشد. توالی تصادفی پیش از تخصیص شرکت‌کنندگان ایجاد شد.
در این مطالعه، شرکت‌کنندگان به‌صورت فردی و با استفاده از روش تصادفی‌سازی بلوکی با اندازه بلوک چهار نفره و نسبت تخصیص شبه۱:۱ به گروه مداخله یا کنترل تخصیص داده شدند. شش توالی تخصیص ممکن تشکیل شد که در هر بلوک شامل دو تخصیص به گروه مداخله و دو تخصیص به گروه کنترل بود و ترتیب تخصیص‌ها در توالی‌های مختلف متفاوت بود. سپس ۷۰ بلوک به‌صورت تصادفی (Quasi-randomization)و با جایگذاری انتخاب شد تا توالی تخصیص برای ۲۸۰ شرکت‌کننده ایجاد شود. شرکت‌کنندگان بر اساس زوج یا فرد بودن شماره پرونده بیمارستانی استفاده شده است. این روشتوالی تصادفی حاصل به شرح زیر اجرا می‌شود: بیماران بر اساس معیارهای شمول و عدم شمول غربالگری می‌شوند. در صورت واجد شرایط بودن، شماره پرونده بیمارستانی آنهامتوالی به عنوان شناسه منحصربه‌فرد ثبت می‌شود. بررسی زوج یا فرد بودن شماره پرونده شماره پرونده بیمارستانی (مثلاً 1400256) بررسی می‌شود: اگر رقم آخر شماره فرد بود (۱, ۳, ۵, ۷, ۹): بیمار در گروه مداخله قرار می‌گیرد. اگر رقم آخر شماره زوج بود (۰, ۲, ۴, ۶, ۸): بیمار در گروهیا کنترل قرار می‌گیرد. گروه هر بیمار بلافاصله پس از تعیین در فایل اکسل یا سیستم ثبت مطالعه ذخیره میشودتخصیص داده شدند. از هیچ نرم‌افزار یا وب‌سایت خاصی برای تصادفی‌سازی لایه‌ای استفاده نمی شودنشد. توالی تصادفی پیش از تخصیص بهشرکتصورت دستی و بر اساس قاعده زوج/فرد انجام میشودکنندگان ایجاد شد.
Recruitment centers
#1
Name of recruitment center - English: Beheshti hospital
Name of recruitment center - Persian: بیمارستان بهشتی مراغه
Full name of responsible person - English: leila Hajitaghi
Full name of responsible person - Persian: لیلا حاجی تقی
Street address - English: East Azerbaijan Province / Maragheh / North Moallem Street / Next to the Driving and Vehicle Licensing Office / Central Headquarters Building of Maragheh University of Medical Sciences
Street address - Persian: استان آذربایجان شرقی/ مراغه/ خ معلم شمالی / جنب اداره راهنمایی و رانندگی/ ساختمان ستاد مرکزی دانشکده علوم پزشکی
City - English: Maragheh
City - Persian: مراغه
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5517858600
Phone: +98 914 907 6020
Fax:
Email: laila30968@gmail.com
Web page address:
Name of recruitment center - English: Beheshti hospital
Name of recruitment center - Persian: بیمارستان بهشتی مراغه
Full name of responsible person - English: leila Hajitaghi
Full name of responsible person - Persian: لیلا حاجی تقی
Street address - English: Shahid Dr. Beheshti Hospital Sadoughi Street (or: Shahid Sadoughi St.), Maragheh
Street address - Persian: مراغه، خیابان شهید صدوقی، بیمارستان شهید دکتر بهشتی
City - English: Maragheh
City - Persian: مراغه
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5513965895
Phone: +98 914 907 6020
Fax:
Email: laila30968@gmail.com
Web page address:
Name of recruitment center - English: Beheshti hospital Name of recruitment center - Persian: بیمارستان بهشتی مراغه Full name of responsible person - English: leila Hajitaghi Full name of responsible person - Persian: لیلا حاجی تقی Street address - English: East Azerbaijan Province / Maragheh / North MoallemShahid Dr. Beheshti Hospital Sadoughi Street / Next to the Driving and Vehicle Licensing Office / Central Headquarters Building of(or: Shahid Sadoughi St.), Maragheh University of Medical Sciences Street address - Persian: استان آذربایجان شرقی/ مراغه/ خ معلم شمالی / جنب اداره راهنمایی و رانندگی/ ساختمان ستاد مرکزی دانشکده علوم پزشکی، خیابان شهید صدوقی، بیمارستان شهید دکتر بهشتی City - English: Maragheh City - Persian: مراغه Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 55178586005513965895 Phone: +98 914 907 6020 Fax: Email: laila30968@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: دکترابراهیم علی افسری
Full name of responsible person - Persian: Dr Ebrahim Aliafsare
Street address - English: East Azerbaijan Province / Maragheh / North Moallem Street / Next to the Driving and Vehicle Licensing Office / Central Headquarters Building of Maragheh University of Medical Sciences
Street address - Persian: استان آذربایجان شرقی/ مراغه/ خ معلم شمالی / جنب اداره راهنمایی و رانندگی/ ساختمان ستاد مرکزی دانشکده علوم پزشکی
City - English: Maragheh
City - Persian: مراغه
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5517858600
Phone: +98 914 907 6020
Fax:
Email: laila30968@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Ebrahim Aliafsare
Full name of responsible person - Persian: دکتر ابراهیم علی افسری
Street address - English: Central Headquarters Building, North Moallem Street, Adjacent to Road Traffic Police Department, Maragheh
Street address - Persian: مراغه، خیابان معلم شمالی، جنب اداره راهنمایی و رانندگی، ساختمان ستاد مرکزی دانشکده علوم پزشکی
City - English: Maragheh
City - Persian: مراغه
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5517858600
Phone: +98 914 907 6020
Fax:
Email: laila30968@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: دکترابراهیم علی افسریDr Ebrahim Aliafsare Full name of responsible person - Persian: Dr Ebrahim Aliafsareدکتر ابراهیم علی افسری Street address - English: East Azerbaijan Province / Maragheh /Central Headquarters Building, North Moallem Street / Next, Adjacent to the Driving and Vehicle Licensing Office / Central Headquarters Building ofRoad Traffic Police Department, Maragheh University of Medical Sciences Street address - Persian: استان آذربایجان شرقی/ مراغه/ خ، خیابان معلم شمالی /، جنب اداره راهنمایی و رانندگی/، ساختمان ستاد مرکزی دانشکده علوم پزشکی City - English: Maragheh City - Persian: مراغه Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5517858600 Phone: +98 914 907 6020 Fax: Email: laila30968@gmail.com Web page address:
Protocol summary
Study aim
Evaluating the Impact of Tele-Nursing on Self-Efficacy, Social Support, and Exclusive Breastfeeding Experience in First-Time Mothers
Design
A controlled, parallel-group, randomized phase 2 clinical trial conducted on 280 patients. Eligible participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio.
Settings and conduct
Study location: The labor and delivery unit of Shahid Doctor Beheshti Hospital in Maragheh.
Study population: Postpartum mothers following hospital discharge.
Methodological note: No blinding will be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous mothers; Informed parental consent to participate in the study; Breastfeeding the infant at the time of discharge; Having family support for the mother (mother, spouse, etc.); Gestational age of 37-42 weeks at delivery.
Exclusion criteria: Medical contraindication for breastfeeding in mother or infant; Parents employed in hospital-related professions; Any congenital anomalies or abnormalities in the infant
Intervention groups
Control Group:The control group will receive only standard care.
Intervention Group:An educational channel and training group will be established on approved national platforms. The intervention will consist of four stages of breastfeeding counseling, conducted according to the GATHER counseling principles.
Main outcome variables
Breastfeeding self-efficacy, maternal breastfeeding social support, mothers' exclusive breastfeeding experience
General information
Reason for update
The trial record is being updated to correct, complete, and clarify the information regarding the allocation of participants. In the previous version of the record, the participant allocation method was described as pseudorandom allocation based on the parity (even or odd) of the hospital record number. This description did not accurately and completely reflect the allocation method used in the conduct of the study. Therefore, the randomization-related information is being revised to accurately and transparently document the participant allocation procedure used in the trial.
Specifically, the “Randomization (investigator's opinion)” field is being changed from “Not randomized” to “Randomized,” and the “Randomization description” field is being revised to describe individual-level block randomization with a block size of four and a 1:1 allocation ratio. The formation of six possible allocation sequences and the random selection with replacement of 70 blocks to generate the allocation sequence for 280 participants are also documented. This update is intended to improve the accuracy and transparency of the trial record and to accurately reflect the allocation method used in the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20241225064172N1
Registration date:2025-05-28, 1404/03/07
Registration timing:prospective
Last update:2026-09-30, 1405/07/08
Update count:1
Registration date
2025-05-28, 1404/03/07
Registrant information
Name
Leila Hajitaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 907 6020
Email address
hajitaghi@mrgums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-05, 1404/03/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers: A clinical trial study
Public title
The effect of telenursing on self-efficacy, social support, and exclusive breastfeeding experience of primiparous mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous mothers
Informed parental consent to participate in the study
Exclusive breastfeeding at the time of discharge
Ability to read and write in Persian (Parents)
Family support for the mother from her mother, spouse, etc
Owning a mobile phone compatible with the Ita app
Gestational age of 37–42 weeks at the birth of term infants
Exclusion criteria:
Medical contraindication for breastfeeding for either mother or infant
Employed in a hospital-related profession
Congenital anomalies or abnormalities in the infant
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were individually allocated to the intervention or control group using block randomization with a block size of four and a 1:1 allocation ratio. Six possible allocation sequences were formed, with each block containing two intervention and two control allocations in different sequences. Seventy blocks were randomly selected with replacement to generate the allocation sequence for the 280 participants. Participants were subsequently allocated sequentially to the intervention or control group according to the resulting randomization sequence. No stratified randomization was used. The randomization sequence was generated before participant allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Maragheh University of Medical Sciences
Street address
No. 113, North Saba Alley, Azadegan Street, Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5517858600
Approval date
2025-04-16, 1404/01/27
Ethics committee reference number
IR.MARAGHEHPHC.REC.1404.001
Health conditions studied
1
Description of health condition studied
Breastfeeding Education for Mothers via Tele-Nursing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy score of primiparous mothers
Timepoint
Before the intervention, and at one week, one month, and six months after the intervention
Method of measurement
Dennis Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
2
Description
Maternal Breastfeeding Social Support
Timepoint
Before the intervention, and at one week, one month, and six months after the intervention
Method of measurement
Exclusive Breastfeeding Social Support Scale
3
Description
Mothers' Experience of Exclusive Breastfeeding
Timepoint
Before the intervention, and at one week, one month, and six months after the intervention
Method of measurement
Breastfeeding Experience Scale (BES)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An educational channel and educational group will be established in nationally authorized settings, and the intervention will be carried out in four stages, according to the GATHER counseling principles and the Ministry of Health breastfeeding protocol. (Each of the stages will be carried out for one week, two days a week, on Saturdays and Mondays at 7 p.m.) We will explain to the mothers that they should view the educational content with a sponsor (mother or spouse or...). The questionnaires of the present study will be completed by the participants before the start of the intervention, one week, one month, and six months after the end of the intervention.
Category
Other
2
Description
Control group: Mothers in the control group will receive only standard care, including routine breastfeeding education and pamphlets about breastfeeding.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
leila Hajitaghi
Street address
Shahid Dr. Beheshti Hospital Sadoughi Street (or: Shahid Sadoughi St.), Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5513965895
Phone
+98 914 907 6020
Email
laila30968@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
Dr Ebrahim Aliafsare
Street address
Central Headquarters Building, North Moallem Street, Adjacent to Road Traffic Police Department, Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5517858600
Phone
+98 914 907 6020
Email
laila30968@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maragheh 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
Maragheh University of Medical Sciences
Full name of responsible person
Leila Hajitaghi
Position
Instructor, Faculty Member of the Nursing Department
Latest degree
Master
Other areas of specialty/work
Pediatrics
Street address
No. 113, North Saba Alley, Azadegan Street, Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5517858600
Phone
+98 914 907 6020
Email
laila30968@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
leila Hajitaghi
Position
Instructor, Faculty Member of the Nursing Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 113, North Saba Alley, Azadegan Street, Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5517858600
Phone
+98 914 907 6020
Email
laila30968@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Maragheh University of Medical Sciences
Full name of responsible person
leila Hajitaghi
Position
Instructor, Faculty Member of the Nursing Department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 113, North Saba Alley, Azadegan Street, Maragheh
City
Maragheh
Province
East Azarbaijan
Postal code
5517858600
Phone
+98 914 907 6020
Email
laila30968@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study results will be published in the groups and channels created for participants, without mentioning any personal names
When the data will become available and for how long
Access period begins 6 months after results publication
To whom data/document is available
Mothers of infants
Under which criteria data/document could be used
For training purposes at the hospital
From where data/document is obtainable
laila30968@gmail.com
What processes are involved for a request to access data/document
Sending an email
Comments
Please ensure the registered data becomes visible after article publication.