Investigating the effect of using breastfeeding application and face-to-face training on breastfeeding self-efficacy and weighing neonates of prime parous mothers
Comparison of training through the application and face-to-face training with the usual method on the self-efficacy of mothers breastfeeding and weighing the baby
Design
The current research is a phase 2 randomized clinical trial with two intervention groups, training through software and face-to-face training with parallel groups without blinding and a control group receiving routine training in health centers, the study sample through group allocation) sample selection includes 144 people in each group, 48 people is
Settings and conduct
Sampling from 3 nearby health centers face-to-face training group: information according to the standard training courses of the Ministry of Health was prepared in the form of PowerPoint and during 4 sessions from week 35 to 37 and one session 3-5 days later It will be provided to mothers from childbirth. 2- Application group: First, the application will be designed and evaluated, and during a 15 to 30-minute session, it will be installed on mobile phones and how to use it will be explained to mothers. 3- Routine training of the health center. will be found) in all three groups at 15 days at the end of the first month and at the end of the second month after birth, using a scale and weighing the baby and the standard Dennis breastfeeding self-efficacy questionnaire and the exclusive breastfeeding checklist will be done
Participants/Inclusion and exclusion criteria
There is no harm
Intervention groups
Face-to-face training during 4 sessions from 35 to 37 weeks and 3 to 5 days after delivery 2- The application will be installed and trained on Hamran's phone during a 20-30 minute session 3- Control group: routine care
Main outcome variables
Self-efficacy, baby weighing, amount of exclusive feeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230729058965N1
Registration date:2023-09-19, 1402/06/28
Registration timing:prospective
Last update:2023-09-19, 1402/06/28
Update count:0
Registration date
2023-09-19, 1402/06/28
Registrant information
Name
Fateme Baluch
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4244 3524
Email address
balouchf4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using breastfeeding application and face-to-face training on breastfeeding self-efficacy and weighing neonates of prime parous mothers
Public title
The effect of breastfeeding education with face-to-face application on mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
singleton pregnancy
term
healthy baby
weight more than 2500
no dependence on drugs
mother's lack of education in fields related to medicine
ability to use a mobile phone
no prohibition of breastfeeding
Exclusion criteria:
The unwillingness of the mother to cooperate and admit the baby to the intensive care unit
absence of more than one session in breastfeeding counseling sessions
the death of the baby and the occurrence of unfortunate events in the family (death, accident and illness)
and the inability to use the application in the follow-up The next ones
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research is group allocation in such a way that the study sample is randomly selected from health centers number 5, 4, 3, 2, 1 and 2, and one center is selected from the health centers under the collection of these bases and to be homogeneous. The samples will be selected from two centers adjacent to this health center and sampling will be done by simple randomization. (due to lack of communication between trainees)
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 Mashhad University of Medical Sciences
Street address
Ferdowsi University, Faculty of Nursing and Midwifery, Vakil Abad Boulevard, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-09-16, 1402/06/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.071
Health conditions studied
1
Description of health condition studied
Breastfeeding education, breastfeeding problems and breastfeeding self-efficac
ICD-10 code
P92Feeding
ICD-10 code description
P92.0Vomiting in newbornP92.1Regurgitation and rumination in newbornP92.2Slow feeding of newbornP92.3Underfeeding of newbornP92.4Overfeeding of newbornP92.5Neonatal difficulty in feeding at breastP92.8Other feeding problems of newbornP92.9Feeding problem
Primary outcomes
1
Description
Breastfeeding self-efficacy is the mother's perceived ability to breastfeed her infant
Timepoint
Before starting the study and 15 days after the end of the first month and the end of the second month after birth
Method of measurement
Dennis self-efficacy questionnaire, exclusive feeding checklist, baby weighing scale
Secondary outcomes
1
Description
Self-efficacy is the mother's perceived ability to breastfeed her baby
Timepoint
Before starting the intervention, then on the 15th day, the end of the first month and the end of the second month of birth
Method of measurement
1- Weighing the baby using a scale 2- The Fax and Dennis breastfeeding self-efficacy questionnaire includes 33 questions with a positive weight based on the Likert scale 3- The exclusive feeding check list
Intervention groups
1
Description
Intervention group: The intervention group will be randomly assigned to the face-to-face training group in the form of 3 weekly sessions in weeks 35-37 and one session in 3-5 days after delivery, educational information according to the content of the group. The application will be provided (all trainings are based on the training courses of the Ministry of Health)
Category
Behavior
2
Description
Intervention group: Intervention groups: The second intervention group will be randomly assigned an educational application (created by the project partner) will be installed on their mobile phone, so that how to use and access information is fully taught to mothers in a 15-30 minute session. Then they will be given explanations on how to use the application.
Category
Behavior
3
Description
Control group: Control group: The control group will be placed in this group after randomly allocating the samples and will only receive the routine care and training of the health center.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rezashahr comprehensive health service center Community Verified icon
Full name of responsible person
fateme erfanian
Street address
8 Zakaria, 11 Pirouzi,Pirouzi Blvd. Mashhad,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3879 2262
Email
erfanianF@mums.ac.ir
2
Recruitment center
Name of recruitment center
Sarafrazan comprehensive health service center Community Verified icon
Full name of responsible person
fateme erfanian
Street address
, Pirouzi 26, Farqani 7, next to Bostan Rose،Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3876 5011
Email
erfanianF@mums.ac.ir
3
Recruitment center
Name of recruitment center
Comprehensive Ab and Bargh health service center
Full name of responsible person
fateme erfanian
Street address
13 Villa St., Vila Haft Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3866 6046
Email
erfanianF@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatema erfanian
Street address
Iran, Mashhad, Razavi Khorasan Province, University St., Central Organization of Mashhad University of Medical Sciences, Qureshi Building Community Verified icon
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Email
erfanian@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
fateme baluch
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad, Vakil Abad Boulevard, Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0513591511
Email
balluch1376@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fateme erfanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ferdowsi University, Faculty of Nursing and Midwifery, Vakil Abad Boulevard, Mashhad
City
neyshabour
Province
Razavi Khorasan
Postal code
9137913199
Phone
0513591511
Email
erfanianF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
fateme baluch
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ferdowsi University, Faculty of Nursing and Midwifery, Vakil Abad Boulevard, Mashhad
City
neyshabour
Province
Razavi Khorasan
Postal code
9137913199
Phone
0513591511
Email
balouchF4001@mums.ac.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
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