Determining The effect of education on mothers' self-efficacy in breastfeeding process
Design
This study was designed as a single-blinded randomized clinical trial with parallel groups and a sample size of 70 people in each group.
Settings and conduct
The study will be conducted at Kamali Hospital on pregnant women. Patients who signed informed consent will be randomly divided into two groups. The first group will receive breast feeding education through lectures . The second group will not receive any intervention.
Participants' self-efficacy is measured by a questionnaire before and after the intervention . The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnancy; the fetus should not have any complications on ultrasound, without communication or hearing problems; pregnancy without complication; without possibility of premature birth.
Exclusion criteria: history of preterm labor gestational age over 34 weeks; medical complication that affects breastfeeding; fetal abnormalities; the mother does not accept exclusive breastfeeding; nipple retraction or anatomical problem of the breast; hospitalization of mother and infant; pregnancy by assisted reproductive technology.
Intervention groups
Intervention group: breastfeeding topics are taught in 4 40-minute sessions through lectures. In 28, 30, 32 and 34 weeks of pregnancy. The first session on the benefits of breast milk. The second session: breast problems. Session 3: Risks of bottle-feeding. Session 4: child-friendly hospitals and a summary of previous sessions. Control group: without intervention.
Main outcome variables
Self-efficacy in knowing the benefits of breastfeeding
Self-efficacy in proper breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210915052481N1
Registration date:2021-10-16, 1400/07/24
Registration timing:prospective
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
Fateme Shirpak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3455 7514
Email address
shirpakfateme@vatanmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the impact of training on postpartum mother self efficacy in breast feeding process
Public title
The effect of training on self-efficacy in breastfeeding process
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy
The fetus should not have any complications on ultrasound
Without communication or hearing problems
Pregnancy without complication
There is no possibility of premature birth
Exclusion criteria:
History of preterm labor
Gestational age over 34 weeks
Medical complication that affects breastfeeding
Fetal abnormalities
The mother does not accept exclusive breastfeeding
Nipple retraction or anatomical problem of the breast
Hospitalization of mother and infant
Pregnancy by assisted reproductive technology
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 140 people, with 70 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of blocks considered is 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
140 cards containing sequences of treatments will be written and a10-digit random code, as the patient’s identification number, will be provided for each packet. When the researcher announces the eligibility of a patient, the methodologist will provide the researcher with the envelope. The person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. Data analysis will be carried out by a statistician who is aware of all the processes performed.the participants are aware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-08-25, 1400/06/03
Ethics committee reference number
IR.ABZUMS.REC.1400.141
Health conditions studied
1
Description of health condition studied
Breast feeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Self-efficacy in knowing the benefits of breastfeeding
Timepoint
Before and after intervention
Method of measurement
Dennis Standard Questionnaire
2
Description
Self-efficacy in proper breastfeeding
Timepoint
Before and after intervention
Method of measurement
Dennis Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: breast-feeding topics are taught in 4 40-minute sessions through lectures. In 28, 30, 32 and 34 weeks of pregnancy. The first session : the benefits of breast milk. The second session: breast problems. Session 3: Risks of bottle-feeding. Session 4: Child-friendly hospitals and a summary of previous sessions.
Category
Prevention
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Fateme shirpak
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3455 7514
Email
Shirpakfateme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Fateme shirpak
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
Shirpakfateme@vatanmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fateme shirpak
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
Shirpakfateme@vatanmail.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fateme shirpak
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
Shirpakfateme@vatanmail.ir
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
No - There is not 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