This is a single blind intervention study that will be done on 300 nulliparous women admitted to Saveh hospitals after delivery. Tools using in this study will be two questionnaires and a checklist that will be given to the individuals who wishing to participate in the study. To prevent the relationship between intervention and control group, the hospitals will be divided in intervention and control groups randomly. To prevent the relationship between intervention groups, at the begin of each day, the rooms will be randomly divided in two groups: first group 20 minutes face to face training
The instruction will be given to the second group, without training. Control group will receive routine hospital program. The instruction package includes a video CD and a Pamphlet that will be designed and constructed by the researcher. After three months, the breast feeding self efficacy score, mother‘s knowledge and practice will be measured using checklist and questionnaires by home visiting the subjects. Then the self efficacy score, knowledge and practice in two intervention groups will be compared with control group. For data analysis, SPSS software, version 16 will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102275912N4
Registration date:2012-09-24, 1391/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Mandana Mir Mohammad Ali Ei
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mirmohammad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational package on breastfeeding self- efficacy in postpartum period.
Public title
Effect of educational package on breastfeeding self- efficacy in postpartum period.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Having a healthy newborn; Singleton pregnancy; primiparity; Having at least basic literacy; Pregnancy without High Risk Conditions; No smoking mothers; Living in Save; Having a phone number; Having the CD divice at home.exclusion criteria: mother or infant conditions, illness during the study that breastfeeding is contraindicated.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Sixth Floor, Central University, , Qods Street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2012-06-16, 1391/03/27
Ethics committee reference number
332/130/د/91
Health conditions studied
1
Description of health condition studied
breast feeding education
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
breastfeeding self efficacy
Timepoint
3 month after
Method of measurement
Questionnaire
2
Description
breastfeeding knowledge
Timepoint
3 month after
Method of measurement
Questionnaire
3
Description
breastfeeding practice
Timepoint
3 month after
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: usual care after delivery
Category
Behavior
2
Description
The instruction package includes a video CD and a Pamphlets that will be designed and constructed by the researcher. The instruction will be given to study examples face to face for twenty minutes by researcher. The package Content is: benefits for mother and baby , the correct method of breastfeeding, duration of breastfeeding , common problems and ways to deal with it during lactation.
Category
Behavior
3
Description
The instruction package includes a video CD and a Pamphlets that will be designed and constructed by the researcher. The instruction will be given to study examples without training. The package Content is: benefits for mother and baby , the correct method of breastfeeding, duration of breastfeeding , common problems and ways to deal with it during lactation
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Zahra Sohrabi
Street address
Madar square, Save
City
Save
2
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Zahra Sohrabi
Street address
Madar square
City
Save
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Scienes
Full name of responsible person
Dr Unesian
Street address
Sixth Floor, Central University, , Qods Street, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Scienes
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tohid square.
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 66904252
Email
zsohrabi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mandana Mir Mohammad Ali Ei
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tohid square.
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
+98 66904252
Email
mirmohamad1@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Sohrabi
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tohid square.
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 66904252
Email
zsohrabi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)