Comparison Of The Effect Of Face To Face Training And Training Package On The Attitude And Willingness Of Mothers With Premature Babies To Feed With Milk Donated From The Milk Bank
Determining the effect of face-to-face training and educational package on the attitude and willingness of mothers with premature babies to feed with donated milk
Design
A semi-experimental trial will be conducted in two test groups on 66 eligible mothers of premature babies hospitalized in one of the selected medical sciences hospitals of Tehran province. Sampling is done according to the available method according to the entry criteria. The samples were randomly divided into two equal experimental groups 1 and 2.
Settings and conduct
After obtaining permission from the ethics committee and obtaining informed consent from the parents, educational intervention on two groups will be done. Before the intervention, the demographic information questionnaire and attitude and willingness questionnaires towards milk bank are completed by the samples. For the first group, direct training will be done face to face, and for the second one, it will be done through a training package. After the training, the study questionnaires will be completed again. The data is entered in spss v20 and statistical analysis is performed.
Participants/Inclusion and exclusion criteria
The inclusion criteria: willingness to participate in the study; premature babies who are unable to feed with breast milk; being literated; not to have a physical or mental problem, have the cooperation in participating in training sessions
The exclusion criteria: the history of using donated milk in the mother's previous babies or first and second degree relatives; religious obstacles; Any medical problem of the baby, digestive disorders, abnormal appearance
Intervention groups
The two experimental groups including: the face-to-face training and educational package
Main outcome variables
The attitude and willingness of mothers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057204N1
Registration date:2023-06-25, 1402/04/04
Registration timing:prospective
Last update:2023-06-25, 1402/04/04
Update count:0
Registration date
2023-06-25, 1402/04/04
Registrant information
Name
Sahar Shahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3660 2208
Email address
s.shahidi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effect Of Face To Face Training And Training Package On The Attitude And Willingness Of Mothers With Premature Babies To Feed With Milk Donated From The Milk Bank
Public title
Comparison Of The Effect Of Face To Face Training And Training Package On The Attitude And Willingness Of Mothers With Premature Babies To Feed With Milk Donated From The Milk Bank
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Wliilngness to participate in the study
Mothers with premature babies hospitalized in the neonatal intensive care unit who are unable to feed with breast milk
Having the ability to take care of a baby and be literate
Not to have a confirmed physical and mental problem and have the necessary training and cooperation in participating in training sessions
Exclusion criteria:
History of using donated milk in the previous babies of the mother or first and second degree relatives
Any reason that prevents you from receiving donated milk, such as religious barriers
Any medical problem, including the baby's digestive problems or other problems and diseases that prevent milk intake.
Abnormal appearance and other problems of premature babies that affect the mother.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly assigned to two groups of face-to-face training and training package in such a way that during the first 4 to 6 sessions, all samples were sampled by the available method and face-to-face training, and the next 4 to 6 sessions were sampled by The available method and training is the use of a training package.
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 Yazd University of Medical Sciences
Street address
Bahonar Square, The Central Building Of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2022-11-16, 1401/08/25
Ethics committee reference number
IR.SSU.REC.1401.079
Health conditions studied
1
Description of health condition studied
Attitude and willingness of mothers with premature babies to donate milk
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The attitude of mothers with premature babies towards feeding from the milk bank
Timepoint
Before the beginning of the educational intervention and after its completion
Method of measurement
A three-part researcher-made questionnaire
2
Description
The willingness of mothers with premature babies towards feeding from the milk bank
Timepoint
Before the beginning of the educational intervention and after its completion
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Direct face-to-face training will take place in the first group. Before the intervention, demographic information is obtained by completing a demographic questionnaire. The interventions include an educational program that is implemented to educate mothers with premature babies in the hospital who are unable to breastfeed. A 2-hour training session is arranged with the agreement of the mothers and in coordination with the departments, and it is implemented by the researcher after completing the milk bank workshop in the milk room located in the department. The training is face-to-face, which includes: the existence of milk banks, the benefits of using donated milk, the comparison of donated milk and formula in terms of ingredients, the disadvantages of powdered milk, prevention of infections and diseases, helping to improve physical and mental development and Encouraging mothers to use donated milk from the milk bank. After completing the training, the mother will be asked to raise any questions or doubts about feeding with donated milk, and the researcher will answer her questions.
Category
Other
2
Description
Intervention group: In the second group, the training content will be the same as the face-to-face group, with the difference that the training content includes video files that can be used on tablets, smart phones, and televisions, and educational booklets approved by professors will be presented to mothers. If the mothers wish, the educational video file will be sent to the authorized messenger, and to ensure that they have read the educational package before completing the questionnaires after the educational interventions, the mothers will be asked about this.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Educational Hospital
Full name of responsible person
Sahar Shahidi
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
11858- 17311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mr. Alireza Moradi
Street address
Bahonar Boulevard, the central building of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
yazd.ircme@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sahar Shahidi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
s.shahidi@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mostafa Javadi
Position
Vice-Chancellor of the Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Scien
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
javadinurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sahar Shahidi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bouali St., Shahid Sadoughi School of Nursing and Midwifery, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
s.shahidi@stu.ssu.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
All participant data can be shared after being unidentified
When the data will become available and for how long
Start the access period after 6 months printing the results
To whom data/document is available
Public
Under which criteria data/document could be used
For use in studies allowed.
From where data/document is obtainable
s.shahidi@stu.ssu.ac.ir
What processes are involved for a request to access data/document
The application will be sent to the project implementer by email and within one week will receive the necessary items.