Protocol summary

Study aim
Determining the effect of motivational interview on breastfeeding self-efficacy of mothers with hospitalized infants
Design
Clinical trial with control group, with parallel group, double-blind, randomized, on 100 patients, by accessible method and simple random
Settings and conduct
Study on mothers with hospitalized infants, Arash and Valiasr hospitals, mothers with selected method available, filling out Dennis and demographic questionnaire, people with breastfeeding self-efficacy below 100 are divided into two groups of intervention and control by simple random method.
Participants/Inclusion and exclusion criteria
.Be a primiparous mother. . The baby is single. . The infant should not be breastfed according to a pediatrician. . The mother has no history of mental disorders. . The intrauterine age of the baby is 37 weeks or more. . The weight of the baby at birth is 2500 grams or more. . The mother has no anatomical problems such as nipple sagging and fissures in the breast . Mothers who have a breastfeeding self-efficacy score below 100 .Absence of more than one session . Mother canceling while studying . Infant death for any reason during the study . Identify contraindications during breastfeeding during the study . The need to hospitalize the infant in the neonatal intensive care unit during the study period
Intervention groups
For the intervention group, 5 motivational interview sessions will be held in groups, twice a week and each session will be held for 45 minutes in groups of 8-12 people. They are breastfed
Main outcome variables
Increase breastfeeding self-efficacy, increase breastfeeding success rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210523051371N1
Registration date: 2021-06-14, 1400/03/24
Registration timing: prospective

Last update: 2021-06-14, 1400/03/24
Update count: 0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Mahdieh Sayad Safapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 7922
Email address
mahd.safapor.6777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-24, 1400/04/03
Expected recruitment end date
2021-07-10, 1400/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational interview on breastfeeding self-efficacy of mothers with neonates hospitalized
Public title
The effect of motivational interview on breastfeeding self-efficacy of mothers with neonates hospitalized
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be a primiparous mother Be baby is single The baby should not be breastfed by a pediatrician The mother has no history of mental disorders Intrauterine age of the baby is 37 weeks or more The weight of the at birth is 2500 grams or more The mother has no anatomical problems such as nipple sagging and fissures in the breast Mothers who have a breastfeeding below 100
Exclusion criteria:
Absence for more than one session Maternal withdrawal during study Infant death for any reason during the study Diagnosis of contraindications during breastfeeding The need for hospitalization of the infant in the neonatal intensive care unit during the study period
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method = simple randomization, in this method, each of the research units has an equal and independent chance to be selected and are randomly selected from a list of community members and the researcher has no involvement in the selection of samples. Crash tool = lottery،In this method, we list the people of the community and then select the required number of samples from them by drawing lots.
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
Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran
Street address
No. 16-Nasr St. 7- Jihad St. - Shahid Mahallati -Army HighwayTown
City
Tehran
Province
Tehran
Postal code
1955743557
Approval date
2021-05-22, 1400/03/01
Ethics committee reference number
IR.IAU.TMU.REC.1400.051

Health conditions studied

1

Description of health condition studied
Breastfeeding self-efficacy below 100 in the Dennis questionnaire
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding self-efficacy in Dennis questionnaire above 100
Timepoint
Measurement of breastfeeding self-efficacy before intervention and one month after intervention
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will hold 5 motivational interview sessions in groups, twice a week and each session for 45 minutes in groups of 8-12 people, one month after the last motivational interview session and when mothers go to the hospital clinic and According to the previous agreement with the researcher, the breastfeeding self-efficacy questionnaire will be filled in again by the intervention group
Category
Lifestyle

2

Description
Control group: The control group will receive only the routine training of the hospital regarding breastfeeding while they are in the hospital, and they will fill in the breastfeeding self-efficacy questionnaire again when they go to the clinic and according to the previous appointment with the researcher (second time).
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Comprehensive Hospital-Valiasr Naja Hospital
Full name of responsible person
Dr. Laden Kashani, Dr. Ayatollah Ebadi
Street address
Valiasr Hospital, NAJA,above Mirdamad,Valiasr St.,Tehran -Arash Women's Comprehensive Hospital, corner of 162 Alley ,Shahid Baghdarnia St. (North Rashid),after Shahid Bagheri Highway,Resalat Highway
City
Tehran
Province
Tehran
Postal code
1443119967-165391598
Phone
+98 21 8877 0022
Email
hosp_arash@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Street address
Islamic Azad University of Medical Sciences Tehran,Khaghani St.,Shariati St.,Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Iaumst.pr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mahdieh Sayad Safapour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 16,Nasr 7 Street,Jahad Street,Shahid Mahalati Town,Artesh Autobahn,Tehran city
City
Tehran
Province
Tehran
Postal code
1955743557
Phone
+98 21 2244 7922
Fax
Email
mahd.safapor.6777@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdieh Sayad Safapour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 16,Nasr 7 Street,Jahad Street,Shahid Mahalati Town,Artesh Autobahn,Tehran city
City
Tehran
Province
Tehran
Postal code
1955743557
Phone
+98 21 2244 7922
Fax
Email
mahd.safapor.6777@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdieh Sayad Safapour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 16,Nasr 7 Street,Jahad Street,Shahid Mahalati Town,Artesh Autobahn,Tehran city
City
Tehran
Province
Tehran
Postal code
1955743557
Phone
+98 21 2244 7922
Fax
Email
mahd.safapor.6777@gmail.com

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
Lack of knowledge about sample satisfaction
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
After the data is not identifiable
When the data will become available and for how long
No timeline has been set yet
To whom data/document is available
Researchers
Under which criteria data/document could be used
In order to remove the restrictions
From where data/document is obtainable
mahd.safapor.6777@gmaill.com
What processes are involved for a request to access data/document
Available by email to researchers after reviewing the application if it is acceptable
Comments
Loading...