Determining the effect of training companions on self-efficacy and breastfeeding behavior in primiparous women
Design
Clinical trial with intervention and control group, in which there is no possibility of blinding, randomized on 112 primiparous pregnant women.
Settings and conduct
Hazrat Nabi Akram (A.S.) Asalouye Hospital.
Primiparous pregnant women of 34 weeks or later, selected by the available method, allocated using the block randomization method to one of the intervention or control groups.
No blinding
Participants/Inclusion and exclusion criteria
Criteria for the inclusion of pregnant women in the study:
Low-risk pregnant women, 34 weeks primiparous, able to have a companion at the time of study entry. Having a positive attitude towards exclusive breastfeeding.
Criteria for pregnant women to be excluded from the study:
Reluctance to participate in the study, high-risk pregnant mothers; Premature delivery before the end of training sessions or before 35 weeks, the baby is unhealthy or sent to the NICU, or having a contraindication for breastfeeding.
Criteria for the inclusion of companions in the study:
being literate in reading and writing; Age over 18 years; preferably married; Not having a negative attitude towards breastfeeding (self-expression), a person who can be with the mother on the day after giving birth, a positive attitude towards exclusive feeding with breast milk.
The criteria for leaving companions from the study:
Unwillingness or ability to participate in the study
Intervention groups
Breastfeeding education, common problems and misconceptions of breastfeeding, breastfeeding position, how to milk and store milk, to mothers in the control group and mothers and their companions in the intervention group.
Main outcome variables
Self-efficacy and breastfeeding behavior in primiparous women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240516061816N1
Registration date:2024-06-28, 1403/04/08
Registration timing:registered_while_recruiting
Last update:2024-06-28, 1403/04/08
Update count:0
Registration date
2024-06-28, 1403/04/08
Registrant information
Name
Sara Razmjoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3726 6670
Email address
s.razmjoo99@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training companions on self-efficacy and breastfeeding behavior in primiparous women
Public title
The effect of training companions on self-efficacy and breastfeeding behavior in primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for the inclusion of pregnant women in the study: - Low-risk pregnant women of 34 weeks of primiparous birth who have a conscious desire and decision to breastfeed and have a record of pregnancy care and a history of regular visits in the mentioned hospital. - Pregnant women who are able to choose the person who is supposed to be with them during childbirth and can introduce a person who meets the entry criteria to the research team. Pregnant women who have a positive attitude towards exclusive breastfeeding.
Criteria for the inclusion of companions in the study: being literate in reading and writing; Age over 18 years; preferably married; Not having a negative attitude towards breastfeeding (self-expression), a person who can be with the mother on the day after giving birth, and still have a relationship with the mother after that, and also have a positive attitude towards exclusive feeding with breast milk.
Exclusion criteria:
Criteria for the withdrawal of pregnant women from the study: - mothers who do not want to continue participating in the study, mothers who suffer complications that place them in the group of high-risk pregnancies; Mothers who give birth before the end of the training sessions or before 35 weeks, whose baby is unhealthy or sent to the NICU, or who has a contraindication for breastfeeding, will be excluded from the study.
The criteria for leaving companions from the study:A companion who does not have the desire or ability to continue participating in the study.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:
Block randomization will be done in blocks of four for two intervention and control groups using Stata software. The letter A is considered for the intervention group and the letter B for the control group, then all the substitution information of the letters AA and BB will be 6 different combinations (AABB/ BBAA/ ABAB/ BABA/ BAAB/ ABBA). It is worth mentioning that in this study, there is no possibility of blinding.
Hiding the random assignment:
In order to hide the assigned codes, after identifying the relevant codes, they are placed in envelopes and the selection order is recorded on the envelopes.
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 Tehran University of Medical Sciences
Street address
Headqarters of Tehran University of medical sciences, Keshavarz blvd, Qods corner
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.TUMS.FNM.REC.1403.019
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy of primiparous women
Timepoint
From the birth of the baby to 2 months after delivery
Method of measurement
BSES-SF standard tool to measure breastfeeding self-efficacy
2
Description
Breastfeeding behavior in primiparous women
Timepoint
From the birth of the baby to 2 months after delivery
Method of measurement
Breastfeeding observation checklist notified by the Ministry of Health
Secondary outcomes
1
Description
Exclusive breastfeeding
Timepoint
From the birth of the baby to two months after delivery
Method of measurement
Researcher made Questionnaire
Intervention groups
1
Description
Intervention group: Breastfeeding education, breastfeeding positions, examination of misconceptions and common problems in breastfeeding, how to milk and store milk, to pregnant mothers and their companions during 4 face-to-face sessions in the hospital for women 34 weeks later and questions and answers on the network virtual
Category
Behavior
2
Description
Control group: Breastfeeding training, breastfeeding positions, checking misconceptions and common problems in breastfeeding, how to milk and store milk, only for pregnant mothers during 4 face-to-face sessions in the hospital for women 34 weeks later and questions and answers on the network virtual
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Nabi Akram Asalouye Social Security Hospital affiliated to Bushehr University of Medical Scie
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
fnm@tums.ac.ir
Web page address
https://fnm.tums.ac.ir/
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 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Razmjoo
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
(East Nusrat), Dr. Mirkhani St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
S.razmjoo99@gmail.com
Web page address
Https://fnm.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Razmjoo
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
(East Nusrat), Dr. Mirkhani St, Tawheed square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
S.razmjoo99@gmail.com
Web page address
Https://fnm.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Razmjoo
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
(Easst Nusrat), Dr. Mirkhani St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
S.razmjoo99@gmail.com
Web page address
Https://fnm.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All study data can be published after de-identification of subjects
When the data will become available and for how long
The access period starts from the end of 1404
To whom data/document is available
Data for researchers working in academic and scientific institutions and people who are also engaged in industry can apply to receive them
Under which criteria data/document could be used
In order to support exclusive breastfeeding, by sending a request to the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences
From where data/document is obtainable
Sending the application to the researcher and Faculty of Nursing and Midwifery of Tehran University of Medical Sciences
What processes are involved for a request to access data/document
Sending the application to the researcher and then through the researcher, the application to the Faculty of Nursing and Midwifery of Tehran University of Medical Sciences