Assessing the effectiveness of the educational program based on the theory of planned behavior on donating breast milk to the milk bank in breastfeeding mothers
Determining the effectiveness of the educational program based on the theory of planned behavior on donating breast milk to the milk bank in nursing mothers
Design
A quasi-experimental study with an intervention group and a control group, not being randomized and not being blinded, on 66 breastfeeding mothers
Settings and conduct
Among all health centers affiliated to Tehran university of medical sciences Two centers that nursing mothers visit the most and have the equipment to hold in-person classes will be selected. Then we randomly chose one center for collecting intervention (33 people) and one center for control group (33 people). Nursing mothers who meet the study entry criteria and have expressed their consent will be selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Mother's willingness to participate in the study; Being a resident of Tehran; Breastfeeding now; Having an infant under one year old; mother has sufficient breast milk for her own baby with the approval of a doctor or midwife; Not taking drugs or, smoking and not being addicted; Mother has no psychological or medical problem; Infant has no psychological or medical problem
Intervention groups
Intervention group will start receiving 60-minute weekly educational program based on TPB components preferably face-to-face for 4 weeks at the health center. Control group will receive only routine care and they will not receive any intervention.
Assessing the effectiveness of the educational program based on the theory of planned behavior on donating breast milk to the milk bank in breastfeeding mothers
Public title
Assessing the effectiveness of the educational program based on the theory of planned behavior on donating breast milk to the milk bank in breastfeeding mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's willingness to participate in the study
Being a resident of Tehran
Being breastfeeding mother
Having an infant under one year old
Mother's breastmilk is sufficient for her own baby with the approval of a doctor or midwife
Exclusion criteria:
taking drugs or being smoker or being addict
Mother has any kind of serious medical or psychological conditions
Infant has any kind of serious medical or psychological conditions
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.TUMS.FNM.REC.1401.150
Health conditions studied
1
Description of health condition studied
Breast milk donation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The number of mothers who has donated their breast milk
Timepoint
Before, immediately and 3 months after intervention
Method of measurement
The researcher made questionnaire that includes 7 sections. The first part is to check the demographic information including age, education, number of pregnancies, delivery method, gender of the current child, etc. The second part includes questions related to knowledge with a four-option scale. The third part includes questions related to attitude with a five-point Likert scale, the fourth part includes questions related to subjective norms with a five-point Likert scale, the fifth part includes questions related to perceived behavioral control with a five-point Likert scale, the sixth part includes questions related to Behavioral intention with a five-point Likert scale and the seventh part of the questions related to the behavior of breast milk donation.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will consist of 33 nursing mothers referring to the intervention health center, who will be selected by convenience sampling method. For the mothers of the intervention group, 4 weekly 60-minute training sessions will be held based on components of theory of planned behavior in person at the health center and if it is not possible, it would be held virtually. In order to prevent the loss of samples and increase the flexibility of the face-to-face training program for mothers, the number of training courses will be planned as 3 courses of 11 people, and the duration of each course will be 4 weeks considering the weekly sessions.
Category
N/A
2
Description
Control group: The control group will include 33 nursing mothers referring to the control health center, who will be selected by convenience sampling method. Mothers in this group will only receive routine training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayat health center
Full name of responsible person
Dr Jamal Karimi
Street address
Behind Ghale Marghi Barracks, Mahan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5585 4000
Email
fnm@tums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Mohammad Bagher Health Center
Full name of responsible person
Dr Ahadpoor
Street address
Azadegan west, Morteza Gard town, Behdasht St, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5519 3878
Email
fnm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahzad Pashaeipour
Street address
School of Nursing & Midwifery of Tehran University of Medical Sciences, Tohid sq, Nosrat st, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
Email
fnm@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/102053/sec_18/p_1/lang/Fa
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
Fatemeh Shateranni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fatemeshateranni@gmail.com
Web page address
http://fnm.tums.ac.ir/default/lang/Fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shirin Shahbazi Sighaldeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nosrat st, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
shahbazishirin@yahoo.com
Web page address
http://fnm.tums.ac.ir/default/lang/Fa
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Shateranni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nosrat st, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fatemeshateranni@gmail.com
Web page address
http://fnm.tums.ac.ir/default/lang/Fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
because of confidentiality the participant's characteristics wont be shared.