Determining the Effectiveness of a Distance Education Program on Mothers' Empowering in Breastfeeding
Design
72 pregnant women referred to midwifery clinics of educational hospitals affiliated to Babol University of Medical Sciences will be eligible for inclusion in the study (available sampling method) and then Randomized in the two groups of intervention and control.
Settings and conduct
Midwifery clinics of educational hospitals affiliated to Babol University of Medical Sciences (Ayatollah Rouhani and Yahya Nejad Hospitals)
Participants/Inclusion and exclusion criteria
Inclusion criteria :Informed consent, Age over 18 years, the first pregnancy, 30 to 32 weeks’ gestational age, normal breast and nipple, ability to understand and complete questionnaires, lack of physical and mental disorders, Independence on any type of substance according to the mother's personal statement, the singleton pregnancy, Access to the Telegraph mobile phone
Exclusion criteria: High-risk pregnancy (having a disease that interferes with breastfeeding), no cell phone and Lack of internet access.
Intervention groups
The intervention group, in addition to the routine training during pregnancy and after delivery, provides the educational package for lactation in accordance with the education curriculum of the Ministry of Health (the importance and benefits of breastfeeding for mother and infant, proper lactation techniques, How to feed and store milk, possible lactation problems and artificial feeding risks, how to deal with breast problems and lactation) will be sent by telegram message from week 32 every week (on a specified day) to six weeks. The control group will receive only routine education during pregnancy and postpartum
Main outcome variables
Mothers' breastfeeding Empowerment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039728N1
Registration date:2018-07-03, 1397/04/12
Registration timing:registered_while_recruiting
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Fatemeh Bakouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 5313
Email address
f.bakouei@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare effectiveness of the Distance Education Program and Routine training on the Mothers' Empowerment in Breast-Feeding
Public title
Effectiveness of the Distance Education Program on the Mothers' Empowerment in Breast-Feeding
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age over 18 years
The first pregnancy
30 to 32 weeks’ gestational age
Having normal breast and nipple
Ability to understand and complete questionnaires,
lack of physical and mental disorders,
Independence on any type of substance according to the mother's personal statement
The singleton pregnancy
Access to the Telegraph mobile phone
Exclusion criteria:
High-risk pregnancy ( Having a disease that interferes with breastfeeding)
No cell phone
Lack of internet access
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table will be used to allocate random persons to groups. A set of non-template numbers or a system that has been created entirely randomly and in the form of a table.
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
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.031
Health conditions studied
1
Description of health condition studied
Breastfeeding Empowerment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Mothers' Empowerment in Breastfeeding
Timepoint
Before intervention, 4 and 8 weeks after childbirth
Method of measurement
The breastfeeding empowerment questionnaire
Secondary outcomes
1
Description
Duration of exclusive breastfeeding after childbirth
Timepoint
4 and 8 weeks after childbirth
Method of measurement
Follow-up questionnaire on fertility variables
Intervention groups
1
Description
Intervention group: The lactation training package provided In accordance with the training curriculum Ministry of Health of the country will Send Via a telegram message from week 32 of gestation weekly up to 6 weeks, fallow up to resive of lactation training package via message at Intervention group.
Category
Behavior
2
Description
Control group: Only the routine pregnancy and postpartum education Will be taken (Face-to-face training provided by health care workers during maternity care and training provided by postpartum health care staff to client, face-to-face).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rohani hospital
Full name of responsible person
Fatemeh Bakouei
Street address
Ayatollah Rohani hospital, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Yahyanajad hospital
Full name of responsible person
Fatemeh Bakouei
Street address
Shahid Yahyanajad hospital, Modarres Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh bakouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh bakouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 5313
Email
bakouei2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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