Determining the effect of need-based education on self-efficacy and breastfeeding behavior in primiparous women
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 2 on 70 patients. For randomization, the names of the centers will be written on some balls and placed inside a bag and in the other bag the intervention and control groups' name will be placed. Then one ball will be drawn from each bag to determine which group will be allocated to which center
Settings and conduct
1- Study place: Najafi, Villa, Hazrat Rasool and Imamat health centers, which are a subset of health center No. 1 in Mashhad. 2- Study population: Women in the first 34 weeks of labor. 3- In this study, blindness was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age of 34 weeks; being primiparous.
Non-inclusion criteria: medical problems; midwifery problems; anatomical defects and breast surgury.
Intervention groups
In the intervention group, by completing the need assessment form, the educational needs of the research unit are determined. Then, the relevant tutorials are sent to them in the form of video, image and pamphlet in cyberspace. after the intervention and four weeks after delivery, questionnaire will be completed by mothers. The control group will receive routine training at the health center.
The effect of need-based education in comparison with conventional education on breastfeeding self-efficacy and behavior of primiparous.
Public title
The effect of need-based education on breastfeeding behavior and self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All primiparous mothers at 34 weeks of gestation
Exclusion criteria:
Reluctance to participate in the study
Not being Iranian
multiparity
Multiplication
intrauterine growth restriction
Study in medical sciences, psychology and counseling
Existence of depression, anxiety and stress
Existence of midwifery problems and high-risk cases
Age under 18 and over 35 years
Gestational age more or less than 34 weeks
Existence of medical disease
Reluctance to breastfeeding
Lack of access to smart phones
Existence of anatomical defects and breast surgery
Lack of minimum literacy (writing and reading ability)
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using spheres and bags. There are four balls with the names of four health centers in one bag and four balls with two intervention numbers and two control numbers in the other bag. At the same time, one ball will be drawn from each bag to determine which group will be allocated to which center
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 the School of Nursing and Midwifery, Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Ebn_e_sina Ave, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2022-01-16, 1400/10/26
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.080
Health conditions studied
1
Description of health condition studied
Breastfeeding behavior and self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Breastfeeding self-efficacy
Timepoint
At the beginning of the study and four weeks after delivery
Method of measurement
Breastfeeding self-efficacy questionnaire
Secondary outcomes
1
Description
Breastfeeding behaviour
Timepoint
Four weeks after delivery
Method of measurement
IBFAT questionnaire
Intervention groups
1
Description
Intervention group: Breastfeeding training based on needs assessment questionnaire and virtual training in the form of videos, pamphlets and pictures in four to six 45 to 60 minute sessions
Category
Other
2
Description
Control group: Receiving routine training at the health center
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center number 1
Full name of responsible person
Dr. Baratali Arabnezhad
Street address
Between Vakilabad 66 and 68
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3501 8011
Email
pr@mums.ac.ir.hc1
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah Street; Mashhad University of Medical Sciences.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of nurse and midwifery, Ebn_e_sina Ave, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Tafazzolim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of nurse and midwifery, Ebn_e_sina Ave, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Tafazzolim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ailin Azadian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery; Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91897-63898
Phone
+98 51 3522 3446
Email
Azadiana981@mums.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be shared after participants become unrecognizable
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
Currently unknown
From where data/document is obtainable
Sending email to Azadiana981@mums.ac.ir or attending Library of Mashhad School of Nursing to Mashhad, Daneshgah St.
What processes are involved for a request to access data/document
First, sending a requested through email or attending the library of Mashhad School of Nursing in the case of not receiving any response within a week