To determine the effect of health literacy education on breastfeeding self-efficacy in primiparous women.
Design
A clinical trial with a control group and an intervention group with an open label and randomized design is conducted on 80 postpartum women. RANDBETWEEN command of Excel software was used for randomization.
Settings and conduct
Sampling will be done in the health centers of Chalus city. In the intervention group, 4 training sessions will be conducted in the Sky Room. The control group will receive the standard care routine post partum
Participants/Inclusion and exclusion criteria
Having a smart mobile phone- The ability to use smart phones- Primipara- Healthy fetus- Single fetus- Full term baby- Mothers who feed their babies by themselves-Consent to participate in the study
Intervention groups
Intervention group: 4 sessions of 45-60 minutes (one session per week) will receive interventions as a group of 40 people in the Sky Room. The interventions will be implemented by a master's degree student in counseling in midwifery. Mother, disadvantages, benefits of breast milk and colostrum, correct breastfeeding status, methods of continuing breastfeeding, danger signs for mother and newborn. The control group will receive: standard care. After the end of the intervention, they will receive an educational file
Main outcome variables
The primary outcome: Breastfeeding self-efficacy
Secondary outcome: level of breastfeeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150608022609N10
Registration date:2023-02-07, 1401/11/18
Registration timing:registered_while_recruiting
Last update:2023-02-07, 1401/11/18
Update count:0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online health literacy-based education on the self-efficacy of primiparous breast feeding women
Public title
The effect of online health literacy-based education on the self-efficacy of primiparous breast feeding women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a smart phone
Ability to use a smart phone
Primipara
healthy fetus
Single fetus
Full term baby
Mothers who feed their babies by themselves
Consent to participate in the study
Exclusion criteria:
Under the treatment of psychiatric diseases with a doctor's diagnosis
Hospitalization of mother or baby
Inability to breastfeed due to breast problems
Death of mother or baby
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the sample volume, it will be used for random allocation using the block sampling method, the unit of each block is based on the individual.The samples will be assigned to two groups (intervention and control) using block classification. Blocking process using Excel software will be placed in 18 quadruple blocks (the total sample size is 80 people).In this way, the numbers will be generated randomly with the RANDBETWEEN command in the range of 1 to 6. Then, according to the production values of one of the blocks (for the production number of 1 CTTC block, for the production number of 2 CTCT blocks and so on) the samples will be selected and allocated.Based on this, in the Excel software, between the number one and six, if the number 2 (CTCT block) is randomly selected, the first person enters the intervention group, the second person enters the control group, the third person enters the intervention group and the fourth person enters the control group.
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 Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.MAZUMS..REC.1401.15016
Health conditions studied
1
Description of health condition studied
Singleton pregnancy
ICD-10 code
XV
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Breastfeeding self-efficacy
Timepoint
Before the intervention and immediately and three weeks and six weeks after the intervention
Method of measurement
Breastfeeding self-efficacy questionnaire
Secondary outcomes
1
Description
Lactation level
Timepoint
Before the intervention and immediately and three weeks and six weeks after the end of the intervention
Method of measurement
Labbok breastfeeding level checklist
2
Description
Satisfaction with the intervention
Timepoint
Immediately and three weeks and six weeks after the end of the intervention
Method of measurement
Visual Analog Scale: Satisfaction
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group, there are 4 sessions of 45-60 minutes (one session per week) interventions (including training and advice on personal health and the benefits of breastfeeding, comparing the advantages and disadvantages of breast milk and formula, breast changes during breastfeeding and identifying and treating signs of maternal risk After delivery and training to identify and treat infant danger signs and signs of breast milk sufficiency for the baby, as well as mothers' false beliefs about breastfeeding and methods of continuing breastfeeding, milking and storing breast milk and dimensions of health literacy including obtain information/understand information/appraise information/use information) will receive in groups of 20 people in Sky Room.
Category
Behavior
2
Description
Control group: Will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care center of Chalus city number 1
Full name of responsible person
Mahshid Rezayi
Street address
Health Center No. 1, Shahid Harajpoor Street, Palujdeh, Chalus
City
Chalus
Province
Mazandaran
Postal code
4651146184
Phone
+98 11 5222 0260
Email
neginkalvaninytali@gmail.com
2
Recruitment center
Name of recruitment center
Health care center of Chalus city number 3
Full name of responsible person
Mahshid Rezayi
Street address
Imam Reza Blvd., Alavikla, Chalus
City
Chalus
Province
Mazandaran
Postal code
4651146184
Phone
+98 11 5225 2920
Email
neginkalvaninytali@gmail.com
3
Recruitment center
Name of recruitment center
Health care center of Chalus city number 2
Full name of responsible person
Mahshid Rezayi
Street address
In front of Mazar, Ashura Street, Bazarroz, Chalos
City
Chalus
Province
Mazandaran
Postal code
4651146184
Phone
+98 11 5228 2162
Email
neginkalvani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ebrahimnejad
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moallem Square, Moallem Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
sexualhealthresearchcenter@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Negin Kalvani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 5232 8518
Email
neginkalvaninytali@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Shahhosseini
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
zshahhosseini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Negin Kalvani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursin and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
neginkalvaninytali@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