Protocol summary

Study aim
Determining the effect of education through telegram on the self-efficacy of breastfeeding women in postpartum period
Design
The clinical trial was conducted in two groups of control and intervention, semi experimental, non-blind, in each group of 36 patients
Settings and conduct
Research area, Imam Khomeini Hospital in North Khorasan, and the research population of all women who are giving birth and hospitalization in the postpartum period. To prevent communication between the two groups, sampling is done in two periods of 8 weeks and a total of 16 weeks.At first, the control group is selected by continuous sampling. The questionnaires are completed within the first 24 hours after delivery, 4 weeks after delivery and 8 weeks after delivery. After the end of the control group sampling, the intervention group is done in the same way.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a healthy baby and a term, single pregnancy, having no lactation in the mother and the baby, having a smartphone and having access to the social network of the telegram Non-compliance criteria: the occurrence of a disease in the mother or infant, or the conditions that are inconsistent with continuing lactation, lack of access to the telegram
Intervention groups
The study included two groups of control and intervention.The control group only receives routine lactation training at the hospital. In the intervention group, from the first day after delivery for a period of four weeks, a livelihood training content is sent daily to research units on the basis of the individual's need through telegrams in written, audio, visual, or educational video.
Main outcome variables
Self-efficacy of breastfeeding in women after childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171024036972N2
Registration date: 2018-06-24, 1397/04/03
Registration timing: retrospective

Last update: 2018-06-24, 1397/04/03
Update count: 0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
sahar nayebian
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 5560
Email address
nayebiyan2034@gmail.com
Recruitment status
Recruitment complete
Funding source
Government-Tehran University of Medical Sciences
Expected recruitment start date
2017-12-02, 1396/09/11
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The Effect of Mobile Based Education on the Effect of Breastfeeding in Postpartum Period"
Public title
"Effects of Learning through telegram on the breastfeeding self-efficacy"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Having a healthy baby and a term with weight equal to 2500 grams Single pregnancy Pregnancy and low risk childbirth Passing a maximum of 24 hours from delivery Not having a breastfeeding prohibition in mother and baby Do not drink alcohol or tobacco Reading and writing skills Failure to deal with a bad event such as the death of loved ones during the past month Having smart phones and access to the social network Telegram Exit criteria Exclusion criteria: Incidence of maternal or newborn diseases Or circumstances that conflict with the continuation of breastfeeding Exposure to an unpleasant incident such as the death of loved ones Failure to have access to a telegram for more than a week or to repeat the absence of the message For two days after reviewing the cause of non-observation
Exclusion criteria:
The separation of mother and infant after birth or the conditions that contradict breastfeeding Not having smart phone
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a semi-experimental interventional study. At first, the control group is selected. After two months, the three steps of the intervention group questionnaire are selected and trained through the telegram.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Dr. Mirkhani Street, Tohid Square, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3871

Health conditions studied

1

Description of health condition studied
Investigation of self-efficacy of breastfeeding women after delivery, after training through telegram
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-efficacy score for lactation in the fax and Dennis questionnaires
Timepoint
Determine self-efficacy score for lactation during the first 24 hours after delivery (before intervention), 4 weeks (immediately after intervention) and 8 weeks (4 weeks after intervention) after delivery
Method of measurement
breastfeeding self-efficacy questionnaire Fax & Dennis

Secondary outcomes

empty

Intervention groups

1

Description
In the control group, only routine care is provided, which is routinely administered in the hospital and is usually followed by post-delivery care.
Category
Other

2

Description
Intervention group: After completing the control group sampling, the intervention group sampling was done in the same way. In the intervention group, in addition to the training, lactation training was conducted by a mobile researcher using the telegram n
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sahar Nayebian
Street address
Imam Reza Street, Imam Khomeini Hospital
City
Shirvan
Province
North Khorasan
Postal code
9461758341
Phone
+98 58 3622 4011
Email
nayebiyan2034@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Tavakol
Street address
Corner of Qods Street, Keshavarz Boulevard, Central Office of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
nayebiyan2034@gmail.com
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
Sahar Nayebian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr. Mirkhani Street, Tohid Square, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5560
Fax
Email
nayebiyan2034@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahar Nayebian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr. Mirkhani Street, Tohid Square, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5560
Fax
Email
nayebiyan2034@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahar Nayebian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dr. Mirkhani Street, Tohid Square, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 5560
Fax
Email
nayebiyan2034@gmail.com
Web page address

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
"No more information"
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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