Effect of virtual breastfeeding counseling versus control group on self-efficacy and continuity of breastfeeding in nulligravida women: a randomized clinical trial
To assess the effect of virtual breastfeeding counseling versus control group on self-efficacy and continuity of breastfeeding in nulligravida women
Design
This is a randomized clinical trial with control group without blinding, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Comprehensive Health Centers in Hamadan city on 70 eligible nulligravida pregnant women. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Gestation age 36 to 48 weeks
First pregnancy
The possibility of using the Internet and WhatsApp
Being literate
Exclusion criteria:
High risk pregnancy
Intervention groups
Intervention group:
Routine care during breastfeeding in addition to intervention in the form of a face-to-face breastfeeding counseling session for 45 to 60 minutes once a week in the first month, then online breastfeeding counseling via WhatsApp for 20 to 30 minutes every 2 weeks in the second month and then once monthly until the end of 6 months
Control group:
Just routing care during breastfeeding
Main outcome variables
Primary outcome:
Breastfeeding self-efficacy
The type of infant feeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N456
Registration date:2023-01-09, 1401/10/19
Registration timing:prospective
Last update:2023-01-09, 1401/10/19
Update count:0
Registration date
2023-01-09, 1401/10/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of virtual breastfeeding counseling versus control group on self-efficacy and continuity of breastfeeding in nulligravida women: a randomized clinical trial
Public title
Effect of virtual breastfeeding counseling versus control group on self-efficacy and continuity of breastfeeding in nulligravida women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Gestation age 36 to 48 weeks
First pregnancy
The possibility of using the Internet and WhatsApp
Being literate
Exclusion criteria:
High risk pregnancy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.UMSHA.REC.1401.623
Health conditions studied
1
Description of health condition studied
Breastfeeding difficulty
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast
Primary outcomes
1
Description
Breastfeeding self-efficacy
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using Dennis questionnaire
2
Description
The type of infant feeding
Timepoint
before the intervention and 4 weeks after that
Method of measurement
Using a standardized questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during breastfeeding in addition to intervention in the form of a face-to-face breastfeeding counseling session for 45 to 60 minutes once a week in the first month, then online breastfeeding counseling via WhatsApp for 20 to 30 minutes every 2 weeks in the second month and then once monthly until the end of 6 months (including learning about the benefits of exclusive feeding with breast milk, teaching the correct breastfeeding technique, choosing the best method of feeding an infant, signs of hunger and fullness of an infant, prevention and treatment of common breastfeeding problems, teaching how to milk and store milk, feeding in breastfeeding period, warning signs in infancy, factors that enhance breastfeeding, harms of feeding with powdered milk, use of pacifiers and bottles)
Category
Other
2
Description
Control group: Just routing care during breastfeeding
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Behnoosh Jalili Khoei
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
behnoosh.jalili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Behnoosh Jalili Khoei
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
behnoosh.jalili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soodabeh Aghababaii
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aghababaii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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