Evaluation of breastfeeding decision support system to investigate the self-care status of nursing mothers
Design
A clinical trial with a control group with double-blind parallel groups, randomized on 40 patients .Simple randomization through lottery and assigning a code to each participant and writing it on paper and lottery and assigning to each intervention and control group
Settings and conduct
during the intervention phase, which begins at 34 weeks of pregnancy، In the intervention group, the necessary care and training are provided to the mothers at certain intervals by the app and they are asked to study and observe them . Mothers in the control group will receive more basic care through the app .After delivery, the mothers' automatic breastfeeding questionnaire will be completed by the mothers of the intervention and control group, which will be before the intervention and at intervals of 7 days ، 28 Days and 56 days after delivery will be answered. This research will be conducted on mothers of Ahvaz city, who are selected through the city health center through clustering .
Participants/Inclusion and exclusion criteria
Entry requirements :
1. Pregnant mothers between 18 and 40 years old , first child .
2. Not suffering from concomitant diseases (such as BP,GDM, etc.)
3. Having a smart phone
4. Minimum education of diploma
5. A resident of Khuzestan
Intervention groups
In the intervention group, the necessary and personalized care and training through artificial intelligence is provided to mothers at specific intervals by the app and asked to Study and observe them . Mothers in the control group will receive more basic training and functionality from the app
Main outcome variables
Clinical decision support system: Self-efficacy of mothers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240308061211N1
Registration date:2024-06-11, 1403/03/22
Registration timing:prospective
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Mahla Navaser
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5332 3531
Email address
navaser.mahla@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of breastfeeding decision support system to investigate the self-care status of nursing mothers
Public title
Design and evaluation of breastfeeding decision support system to investigate the self-care status of nursing mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers between 18 and 40 years old who are pregnant with their first child.
Not suffering from concomitant diseases (such as blood pressure, gestational diabetes, GDM, etc.)
Having a smart phone
Minimum education is diploma
A resident of Khuzestan
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization would be simple and on an individual basis and through the lottery . A code is assigned to each of the people who entered the study . These codes are written on separate paper and selected through a lottery. The lottery is selected so that one ticket is awarded to the intervention group and the next ticket is assigned to the control group, and so on until the codes are finished.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the project, participants will be explained that the nature of this study is to use an app to improve breastfeeding behaviors. They will also receive general explanations on how to register and use the app. The control and intervention group applications differ due to the facilities they are given. In the control group, the app offers basic breastfeeding capabilities and registers each case, while in the intervention group, it employs artificial intelligence techniques to give personalized care to each user. Participants in the intervention and control groups will be unaware of the difference in their applications, which is how blinding occurs.
The results of this study and reviews will be shown to the clinical caregiver without revealing their affiliation to the intervention or control group (through the codes given to each participant). The clinical caregiver will interpret the results without knowing which patient belongs to which group during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Research and Technology Development Vice-Chancellor of Jundishapur University of Medical Sciences , Room 4 GF , Ahvaz , Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794 61357
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.AJUMS.REC.1402.641
Health conditions studied
1
Description of health condition studied
Pregnant woman
ICD-10 code
Z33.1
ICD-10 code description
Pregnant state, incidental
Primary outcomes
1
Description
Mothers' self-efficacy score in mothers' breastfeeding self-efficacy questionnaire
Timepoint
At the start of the study and before the intervention, the mothers' self-efficacy index will be measured once before using the app, and thereafter every 7 days, 28 days, and 56 days after delivery.
Method of measurement
The BFSE (Breastfeeding self-efficacy) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The app will become accessible to these individuals during their 34th week of pregnancy, which will necessitate two to three weekly sessions of training. However, mothers will be given the option to choose. These tutorials will be personalized via artificial intelligence (fuzzy) techniques . If the mother has a tendency towards a subject, she will be given more explanations about it. After delivery, they can also store every breastfeeding turn and all the health needs of the baby in this app . The app will warn the mother of any departure from the natural process of growth and development through the pre-embedded patterns . And even through fuzzy logic, if the baby has the possibility of getting sick, it warns the mother (clinical friend's decision)
Category
Other
2
Description
control group :The app will be available to these people in the 34 th week of pregnancy, who will provide the mother with training at certain weekly intervals of 2 to3 times . These tutorials will be shown to everyone in this group on a random basis and without any change . After delivery, mothers can store any information about breastfeeding and their baby’s health information and provide a doctor if needed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz city health centers
Full name of responsible person
Pezhman Bakhtyarinia
Street address
Vice-Chancellor of Health ,Jundishapur University of Medical Sciences and Health Services Ahvaz , Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷۱۵۷۹۴
Phone
+98 61 3314 0000
Email
aduaum@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
GF- Vice-Chancellor for Research and Technology - Jundishapur University of Medical Sciences and Healthcare Services- Ahvaz Academic City-Ahvaz-Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahla Navaser
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Department of Health Information Technology , Faculty of Paramedicine , Jundishapur University of Medical Sciences ,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6318678481
Phone
+98 61 3311 5448
Email
Navaser.mahla@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amirabbas Azizi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Department of Health Information Technology , Faculty of Paramedicine , Jundishapur University of Medical Sciences ,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5448
Email
amirabbas.azizi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahla Navaser
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Informatics
Street address
Department of Health Information Technology , Faculty of Paramedicine , Jundishapur University of Medical Sciences ,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6318678481
Phone
+98 61 3311 5448
Email
Navaser.mahla@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
Not applicable
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