Protocol summary

Study aim
The effect of electronic counseling on indicators related to breastfeeding in nulliparous women referring to health centers of Tehran University of Medical Sciences in 1401
Design
Samples 124 people are randomly divided into 2 groups:intervention and control. Primiparous women referred to the health center under the supervision of Tehran University of Medical Sciences, who are included in the study after examining the inclusion criteria. The groups are parallel and without blinding. After collecting the data, their statistical analysis will be performed by SPSS software using descriptive and analytical statistical methods.
Settings and conduct
This is a randomized clinical trial in the field of maternal and child health and breastfeeding, 5 counseling visits by the site of "Virtual Breastfeeding Clinic", of at least 15 minutes with the mother will be done in the intervention group and in each breastfeeding visit in both groups will be observed. Breastfeeding problems will be solved through face-to-face visits. Samples will be selected from the centers of the 10th, 11th, 16th, 17th and 19th regions.There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Mother access to the Internet and knowing how to use it, mother literacy, no fetal malformations, term gestational age, birth weight 2500 to 4000 grams, Single twin, primiparous mother, absence of chronic maternal and childhood diseases Exclusion criteria:hospitalization of the child for any reason, breastfeeding jaundice, absence more than one session in online counseling sessions, radiotherapy
Intervention groups
Intervention group: Electronic counseling in addition to routine breastfeeding procedures Control group: routine breastfeeding measures
Main outcome variables
breastfeeding technique - Mother's perception of milk insufficiency - Breastfeeding self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210907052403N2
Registration date: 2022-08-29, 1401/06/07
Registration timing: registered_while_recruiting

Last update: 2022-08-29, 1401/06/07
Update count: 0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Samira Romina
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3289 7461
Email address
s.romina314@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of electronic breastfeeding counseling on indicators related to breastfeeding in nulliparous women
Public title
The effect of electronic breastfeeding counseling on indicators related to breastfeeding in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's access to the Internet and knowing how to use it mother's literacy mother's decision to continue breastfeeding, no fetal abnormalities birth weight 2500 to 4000 grams Singleton Nulliparous the absence of chronic maternal and childhood diseases, the absence of simultaneous or combined breastfeeding or formula the absence of drugs that affect milk that have contraindications to breastfeeding term gestational age
Exclusion criteria:
Hospitalization of the child for any reason breastfeeding jaundice absence of more than one session in online counseling sessions radiotherapy and maternal cancer any contraindications to breastfeeding Diagnosis of phenylketonuria
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples will be selected by the available method and then divided into two groups of intervention and control by random allocation method. The samples will be divided into 2 intervention and control groups by random allocation method. Based on the calculated sample size, 62 people will be in the intervention group and 62 people in the control group. A quadruple block will be used to allocate individuals in the control and intervention groups. Thus, all possible states are considered for placing the letters A and B in the four blocks, which include a total of 6 states. These 6 modes were numbered from 1 to 6 and the number of required 4 blocks was determined based on the number of samples studied. Then, according to the computer table, random numbers are randomly assigned to the required number of blocks. Then, based on the order of the numbers extracted from the table, the blocks related to each number are listed in order. Finally, when the samples are included in the study, each person will take a specific letter in the order obtained. And 4 random blocks are made with a 1: 1 allocation ratio. In the first stage, women in the first abdomen referred to Tehran Health Sciences Health Centers, who have successfully started breastfeeding in the first week after delivery, are included in the study after examining the inclusion criteria.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a researcher-made questionnaire of demographic and lactation characteristics - Breastfeeding Self-Efficacy Questionnaire (BSES) - BBAT breastfeeding technique assessment checklist and mothers' perceived milk insufficiency questionnaire will be used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences - Central Building - Fifth Floor - Organization Development Management and Human CapitalKeshavarz Blvd, Tehran.
City
tehran
Province
Tehran
Postal code
3441653363
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.200

Health conditions studied

1

Description of health condition studied
Breastfeeding problems
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maternal perception of milk insufficiency
Timepoint
Before the intervention and one week after the study
Method of measurement
Questionnaire of perceived milk insufficiency by mothers

2

Description
Breastfeeding self efficacy
Timepoint
Before the intervention and one week after the study
Method of measurement
Breastfeeding Self efficacy Scale

Secondary outcomes

1

Description
The correct breastfeeding technique
Timepoint
Before the intervention and one week after the study
Method of measurement
Bristol Breastfeeding Technique Assessment Checklist

Intervention groups

1

Description
Intervention group: The intervention in this study is in the form of providing educational materials based on the working method of similar texts and available scientific resources in relation to breastfeeding interventions under the title of professional intervention. Sessions are generally from 15 to 45 minutes and usually take more than 1 time. In this study, 5 consultation visits of at least 15 minutes with the mother were performed in the intervention group and in each breastfeeding visit, both groups will be observed. Each visit includes an educational and counseling component and psychological support. The content of the training includes the following headings: correct method of breastfeeding, frequency and duration of breastfeeding, correct way of hugging the infant, correct method of breastfeeding, effective sucking sign, diagnosis of breastfeeding adequacy in infants up to 6 months only with They are breastfed.
Category
Behavior

2

Description
Control group: Half of the samples that met the inclusion criteria were randomly assigned to the control group and during the study of routine care such as fixed activities (counseling in case of breastfeeding problems, counseling about breast problems in breastfeeding and ..) which is currently implemented in health centers, will benefit.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers under the supervision of Tehran University of Medical Sciences in District 19
Full name of responsible person
Shirin Shahbaziseghalde
Street address
Tehran University of Medical Sciences - Central Building - Fifth Floor - Organization Development Management and Human Capital Keshavarz Blvd, Tehran.
City
Tehran
Province
Tehran
Postal code
3441633365
Phone
+98 21 4291 1000
Email
shahbazishirin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Shahbaziseghalde
Street address
Tehran University of Medical Sciences - Central Building - Fifth Floor - Organization Development Management and Human Capital Keshavarz Blvd, Tehran.
City
Tehran
Province
Tehran
Postal code
3441653362
Phone
+98 21 4291 1000
Email
tumspr@tums.ac.ir
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
Shirin Shahbaziseghalde
Position
Master and executor of the project
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid St. School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3441653362
Phone
+98 21 4291 1000
Email
shahbazishirin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Shahbaziseghalde
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid St. School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3441653362
Phone
+98 21 4291 1000
Email
shahbazishirin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
samira romina
Position
Senior Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
no8, sadoghi 16
City
abyek
Province
Qazvin
Postal code
3441653363
Phone
+98 28 3289 7461
Email
s.romina314@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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