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Survey on the effect of educational intervention using mobile application on breastfeeding self-Efficacy of mothers attending to the Health Center of Rasht

Protocol summary

Study aim
determination the effect of educational intervention using mobile application on breastfeeding self-Efficacy of mothers attending to the Health Center of Rasht
Design
The setting of this study will a comprehensive health center No.4, Rasht, Iran. Participants consist of mothers referring for thyroid screening of their neonates between the 3-5 days after birth. Participants will be selected by convenience sampling and based on the block Randomization will be allocated into two groups of the case and control
Settings and conduct
As mothers give birth in various hospitals (both public and private) in Rasht, but finally they are referred to Comprehensive Health Center No. 4 for screening test, so this center provides a suitable environment for Maternal sampling (5-2 days after delivery).
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study , Rasht city resident, no history of systemic disease, mental illness, alcohol addiction, cigarette smoking and drug abuse, uncomplicated pregnancy, breastfeeding within the last 24 hours, lack of medical contraindication for breastfeeding, ability to read and write, have an Android smartphone and its usage skills
Intervention groups
After completing the first phase questionnaire on the mobile phone of the mothers of the intervention group, the lactation knowledge software is installed and no intervention is conducted in the control group.
Main outcome variables
Initial Outcome: awareness of mothers in breastfeeding Secondary Outcome: breastfeeding efficiency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190615043895N1
Registration date: 2019-11-09, 1398/08/18
Registration timing: retrospective

Last update: 2019-11-09, 1398/08/18
Update count: 0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
A'azam Seddighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
faeghe.sedighi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey on the effect of educational intervention using mobile application on breastfeeding self-Efficacy of mothers attending to the Health Center of Rasht
Public title
Survey on the effect of educational intervention using mobile application on breastfeeding self-Efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Mothers residing in Rasht city No history of systemic disease, mental disorder Lack of Addiction to alcohol, cigarettes and drugs (based on self-report) Breastfeeding in the last 24 hours Uncomplicated pregnancy Lack of medical prohibition for breastfeeding Have a reading and writing literacy Having an Android smartphone and the skill of using the software
Exclusion criteria:
history of systemic disease, mental disorder Feeding with milk powder multiple pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 198
Randomization (investigator's opinion)
Randomized
Randomization description
The investigation units: researchers who are studying the units, Will give them a number from 1 to 198. By random allocation software, a table with 50 rows of blocks Will be designed and each block Will be named A and B. Afterwards, the numbers Will Be placed in each house in order, after that , all numbers Will Be placed in blocks. 50 Quadruple blocks Will Be randomly selected. Random blocks Will be placed in sealed and locked envelopes and Will keep at the Community Health Center No. 4 and no one Will know their sequence. After starting the study, the blocks Are randomly selected daily. Those in house A Are placed in the test group and those in house B Are placed in the 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
National Ethics Committee for Biomedical Research
Street address
Tehran, Ghods Town (West), Between South Falamak and Zarafshan, Iran, Iran - Central Headquarters of the Ministry of Health and Medical Education, block A, thirteenth floor
City
Tehran
Province
Tehran
Postal code
4471683835
Approval date
2019-06-15, 1398/03/25
Ethics committee reference number
IR.GUMS.REC.1398.106

Health conditions studied

1

Description of health condition studied
Self-efficacy of mothers breastfeeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast

Primary outcomes

1

Description
The First Outcome: Mother’s knowledge of breastfeeding
Timepoint
Day 2-5 after delivery. Before intervention
Method of measurement
A shortened and psychometric questionnaire for Denis's lactation self- efficacy. before the implementation of the breast feeding training program is completed by the researcher on the second to fifth day after delivery in both experimental and control groups. Mother's awareness is measured by a breastfeeding self-efficacy questionnaire.

Secondary outcomes

1

Description
Secondary Outcome: the Breastfeeding Self-efficacy
Timepoint
8 weeks after the end of the Intervention
Method of measurement
Short-lived and psychometric inventory of Denis's lactation self-efficacy

Intervention groups

1

Description
Intervention group: After filling the questionnaire, the promotion of the breastfeeding booklet published by the Ministry of Health, based on the benefits of breastfeeding for infants, breastfeeding benefits for mother , breastfeeding ingredients, the usage of pacifier, lactation numbers, how to breastfeed, symptoms of satiety and hunger ,The correct stat of hugging the baby during lactation, the types of Breastfeeding, Breastfeeding Diagnosis, breast feeding Methods , how to save breast milk, melting the Frozen Breast milk , Common Causes of refusing the breast milk , Nipple fissure ، breast hyperemia ,lightweight and premature babies , capsules and powder to increase milk, mother's cold , taking the medicine and lactation at the same time , baby with diarrhea, how to increase mother's milk and the constancy of breastfeeding and Disadvantage of milk powder and an executable program will be installed on mother’s smart phone via Bluetooth and one week after the installation of the software , they will be contacted and they will be answered any questions or problems that mothers have with the software .Then to remind them of this program , they will be sent a message every week .Also, they will give researcher’s phone number to mothers that if they have any questions about the software , they will ask Then, in the eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone.
Category
Other

2

Description
Control group: the control group does not receive any educational intervention. they receive only routine breastfeeding training, which includes training in hospital and comprehensive health centers by health care providers. Then, Two times, 3-5 days after delivery and eighth week after delivery, the questionnaire of breastfeeding self-efficacy will be completed by the interviewer over the telephone.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Comprehensive Health No. 4 in Rasht
Full name of responsible person
DR Farkhonde Nourani
Street address
Rasht - Three Pasteurized Pathways - Comprehensive Health Center
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3382 0051
Email
faeghe.sedighi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Vice-Chancellor's Office for Research
Street address
Rasht-yakhsazi Creator - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr. Zahra Bostani khalesi
Position
Academic Board - Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rasht-yakhsazi Creator - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Bostani Khalesi
Position
Academic Board - Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rasht - yakhsazy Arena - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Bostani KHalesi
Position
Academic Board - Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Rasht - Ice Arena - Student Park- Shahid Beheshti Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4471683835
Phone
+98 13 3355 5056
Email
z_bostani@yahoo.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
Comparing the self-efficacy of mothers breastfeeding with and without using mobile software in the first and eighth week after completing a shortened and psychometric self-efficacy questionnaire for Denis
When the data will become available and for how long
1 years
To whom data/document is available
Faculty Members of Shahid Beheshti Faculty of Midwifery and Nursing, Rasht
Under which criteria data/document could be used
In order to verify the accuracy of the information and with a written and approved request from the research deputy of Shahid Beheshti Faculty of Nursing and Midwifery, Rasht
From where data/document is obtainable
Library of Shahid Beheshti Faculty of Midwifery and Nursing of Rasht as well as a written request from the project implementer
What processes are involved for a request to access data/document
Permission from the librarian of Shahid Beheshti Faculty of Midwifery and Nursing in Rasht in writing
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