Determination of the impact of Peer Education on Breastfeeding Self-Efficacy in Primiparous Women with hospitalized neonate in neonatal ward
Design
Clinical trial with intervention and control group, Randomized using random numbers table, The sample size was 120 people, 60 in the control group and 60 in the intervention group
Settings and conduct
One hundred and twenty samples that sixty people in the control group and sixty in the intervention group are randomized and without blinding and Breastfeeding Education in the Breastfeeding room of the neonatal ward of Amirkola Pediatric hospital and training through peer will be provided to Primiparous Women with hospitalized neonate.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Primiparous Women with a single-term infant (over thirty seven weeks of gestation)؛ Not having a physical or mental illness؛ No structural defects in the breast؛ Mother's desire for Breastfeeding؛ The age range is at least eighteen years and maximum thirty five years؛ Have a reading and writing literacy.
Exclusion criteria:
The presence of problems requiring admission to the NICU؛ Unwillingness to continue the collaboration of primiparas women؛ The desire not to continue the co-operation of the Peer mothers؛ The death of hospitalized infant؛ Prohibition of breastfeeding by a Neonatalogist during the study
Intervention groups
Control mothers will receive usual and standardized training of the center after delivery.The mothers of the intervention group will receive, in addition to the Center's usual training, two sessions of one hour of other breastfeeding training that will be held by the peer in the first week after the delivery.
Main outcome variables
Mean score Of Breastfeeding Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039708N1
Registration date:2018-11-30, 1397/09/09
Registration timing:retrospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Safie Rezapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3220 5537
Email address
s.rezapour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Peer Education on Breastfeeding Self-Efficacy in Primiparous Women with hospitalized neonate in neonatal ward
Public title
Impact of Peer Education on Breastfeeding Self-Efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous Women with a single-term infant (over thirty seven weeks of gestation)
Not having a physical or mental illness
No drug use for special disease
No structural defects in the breast
Having a baby without any Congenital defects
Mother's desire for Breastfeeding
The age range is at least eighteen years and maximum thirty five years
Have a reading and writing literacy
No history of smoking, use alcohol and drugs
The absence of complications during pregnancy and delivery (such as preeclampsia and bleeding)
Exclusion criteria:
The congenital problems or interruptible problems with breast milk (such as buttocks, cleft palate, respiratory or cardiovascular problems
The presence of problems requiring admission to the NICU
Unwillingness to continue the collaboration of primiparas women
The desire not to continue the co-operation of the Peer mothers
The death of hospitalized infant
Prohibition of breastfeeding by a Neonatalogist during the study
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Starting from a random point in the random numbers table And from this point we move forward and down the random numbers table And all numbers on this path are selected as sample members and to avoid the unequal number of samples in the intervention and control groups, a random permutation method is used So that for random numbers 0-4, the random permutation AB And for random numbers 5-9, random permutation BA is used. (A = Intervention and B = Control)
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 Afrooz Avenue., Babol., Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.012
Health conditions studied
1
Description of health condition studied
Breastfeeding Education
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean score of breastfeeding self-efficacy
Timepoint
The beginning of the study (before the intervention) and the end of the eighth weeks after delivery
Method of measurement
Dennis Breastfeeding Self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Mothers of the intervention group, in addition to the standard and standard breastfeeding training, will have two sessions of one hour of other lactation training that will be held in the first week after the delivery by the peer in the weekly classroom (Saturday, Monday, Wednesday) at 9 o'clock In the morning, they will receive lactation at the Nursing Department of Amirkola Children's Hospital. Teaching the same mothers to the mothers of the intervention group as a lecture, along with a question and answer, and providing a booklet and educational pamphlet prepared by the researcher.
Category
Behavior
2
Description
Control group: Control mothers will receive only usual breastfeeding education provided by the center.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children's Hospital
Full name of responsible person
Parvin aziznejadroshan
Street address
Babol University of Medical Sciences., Ganj Afrooz Avenue., Babol.,
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
aziznejadroshan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ghadimi Reza
Street address
Babol University of Medical Sciences., Ganj Afrooz Avenue., Babol., Mazandaran
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
Parvin aziznejadroshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences., Ganj Afrooz Avenue., Babol., Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
aziznejadroshan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin aziznejadroshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences., Ganj Afrooz Avenue., Babol., Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
aziznejadroshan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Safie rezapour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences., Ganj Afrooz Avenue., Babol., Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11321995926
Email
safierezapour@gmail.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