Studying the effect of education based on Pender's health promotion models on successful breastfeeding in pregnant women in selected health centers of Shiraz
Design
In this research, 40 pregnant women (with pregnancy duration more than 32 weeks) were chosen. Then, Participants were randomly divided into two control and intervention groups and a code was allocated to each one of them.
Settings and conduct
This is a two-blind clinical trial that will be carried out in Shiraz's comprehensive health centers so that there will be 6 sessions for the intervention group and there will be no intervention for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria for admission in this study is pregnant women with pregnancy duration more than 32 weeks and the exclusion criteria for this study, non-participation in more than one session.
Intervention groups
For the intervention group,6 sessions will be held. The control group will receive no intervention.
Main outcome variables
successful breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160404027216N6
Registration date:2018-11-10, 1397/08/19
Registration timing:registered_while_recruiting
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of education based on Pender's health promotion models on successful breastfeeding in pregnant women
Public title
Successful breastfeeding training
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women whose duration of their pregnancy is more than 32 weeks.
Lack of breastfeeding prohibition for any reasons.
Ability to read, write and understand and using the trainings.
Exclusion criteria:
Absence more than one session in the training program.
Mother's relinquishment of participating in the research at each stage of the researching.
Former participation at breastfeeding training classes
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
4 social health centers will be chosen by clustering method, subsequently two centers will be assigned as intervention centers and two of them as control ones, based on draw lot method and randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the questionnaire will given to all participants, no one is aware of being in the control or intervention group, also participant's identity will be unbeknownst to the person who is analyzing the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
opposite Phalestine Street, Zand Blvd,Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.Sums.REC.1397.600
Health conditions studied
1
Description of health condition studied
Other problems related to education and literacy
ICD-10 code
Z55.8
ICD-10 code description
Other problems related to education and literacy
Primary outcomes
1
Description
successful breastfeeding
Timepoint
Pre- intervention, Post- intervention,Two months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The implementation of 6 sessions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Community Health Centers
Full name of responsible person
Maryam Saberi
Street address
Namazi Square - School of Nursing and Midwifery- Shiraz- Fars-Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4252
Email
saberi.mari.71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Saberi
Position
Bachelore
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square - School of Nursing and Midwifery- Shiraz- Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
saberi.mari.71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatmeh Vizeshfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square - School of Nursing and Midwifery-Shiraz- Fars- Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
vizeshfarf@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz
Position
Bachelor of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square - School of Nursing and Midwifery- Shiraz- Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
saberi.mari.71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of the data
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publish in domestic and foreign publications and present in credible seminars
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Research team members
Under which criteria data/document could be used
As statistical data in research such as meta-analysis, which requires these data.
From where data/document is obtainable
Maryam Saberi
What processes are involved for a request to access data/document