Protocol summary

Study aim
Investigating the effect of using breastfeeding education mobile software on mothers' satisfaction
Design
384 / 5,000 Translation results In the intervention group, clients and their caregivers, in addition to receiving educational materials and participating in childbirth and breastfeeding preparation classes of Ayatollah Taleghani Center, will be trained using the consolidated discharge method, (education as usual and with application), the patients of the control group will receive necessary training and participate in childbirth and breastfeeding preparation classes of Ayatollah Taleghani Center and will be discharged from the hospital.
Settings and conduct
The present research will be carried out experimentally and by randomized clinical trial method in Ayatollah Taleghani Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: The mother's ability to breastfeed the babyو being literate, having access to a mobile phone with the ability to download software
Intervention groups
In the intervention group, clients and their caregivers, in addition to receiving educational materials and participating in childbirth and breastfeeding preparation classes of Ayatollah Taleghani Center, will be trained using the combined discharge method (education as usual and with application) in the department.
Main outcome variables
Weighing the baby in the first 6 months of birth, promoting breastfeeding of mothers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050189N2
Registration date: 2023-03-14, 1401/12/23
Registration timing: registered_while_recruiting

Last update: 2023-03-14, 1401/12/23
Update count: 0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of breastfeeding education mobile software on Mothers satisfaction
Public title
Investigating the effect of breastfeeding education mobile software on Mothers satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being literate Mobile access with the ability to download software Baby's ability to breastfeed
Exclusion criteria:
Inability of mother and baby to breastfeed for any reason, such as illness of mother or baby
Age
From 18 years old to 55 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Before the start of the intervention, 40 white and 40 black cards are prepared and for randomization, all the cards are placed in an envelope, then the cards are drawn randomly and numbers from 1 to 80 are drawn in order. is placed Then each card is placed in a sealed envelope and its number is written on the card, and when each patient enters the study, a special envelope will be opened for him from 1 to 80 and assigned to the intervention and control group.
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
Vice President of Research and Technology Shahid Beheshti University of Medical Sciences (Research E
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.550

Health conditions studied

1

Description of health condition studied
Promotion of breastfeeding
ICD-10 code
R63.3
ICD-10 code description
Feeding difficulties

Primary outcomes

1

Description
Weighing the baby in the first 1 to 6 months of birth
Timepoint
6 month
Method of measurement
Measuring the baby's weight monthly

2

Description
ارتقا شیر دهی مادران
Timepoint
monthly
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Clients and their caregivers, in addition to receiving educational materials and participating in childbirth and breastfeeding preparation classes of Ayatollah Taleghani Center, will be trained using the consolidated discharge method, (education as usual and with application). Training using mobile phones will be such that all educational content is designed in a mobile application and provided to the participants through an internet link and installed on the participants' mobile phones.
Category
N/A

2

Description
Control group: Clients and their caregivers receive educational materials in the form of paper pamphlets and participate in the childbirth and breastfeeding training class of Ayatollah Taleghani Center.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Center,
Full name of responsible person
Raziyeh Ghafouri
Street address
7th Floor, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shahid beheshti university of medical science
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9982
Email
raziehghafouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198571744
Phone
+98 21 2243 9982
Email
raziehghafouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9982
Email
raziehghafouri@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By request from the coresponder author via email
When the data will become available and for how long
after data ghatering
To whom data/document is available
academic researcher
Under which criteria data/document could be used
By request from the coresponder author via email
From where data/document is obtainable
By request from the coresponder author via email
What processes are involved for a request to access data/document
By request from the coresponder author via email
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