Protocol summary

Study aim
The Effect Of Education Through Cyberspace On The Self-Efficacy And Continuation Of Lactation In Primipara Women
Design
Clinical Trials, Community Based And Pragmatic Control Group, With Parallel Groups, One Blind, Randomized,
Settings and conduct
Field Of Lactation, With Membership In The Cyberspace Group 120-180 Minutes Of Participation In The Class, And Submitting Educational Materials From The Ministry On Breastfeeding And Answering Their Questions
Participants/Inclusion and exclusion criteria
tend to participate in the study. • Minimum Level Of Education Is Read And Write. • None Of The Subjects Studied In The Classroom Will Be Similar To Those Used In This Study. • Access and ability to use cyberspace. • Pregnant Women. • Condition Of Normal Baby (Normal Weight, Term Of Gestational Age, And Non-Abnormality Of The Baby). • A Medical Certificate For Breastfeeding Is Not For Mothers And Children. Sample Removal Criteria: • Unwillingness To Continue Participating In The Study. • Absenteeism At A 120-180 Mnute Training Session. • Leave The Virtual Lactation Training Group.
Intervention groups
Participation In 120-180 Minutes Delivery Training Classes And Then Membership In The Virtual Group (Pre-Test). Lactation Training And Responses To Breastfeeding Questions From 28 Weeks Of Gestation To 4 Months Postpartum. Control group: Maternal Postpartum Routine Training (Pre-Test) And 4 Months Later (Post-Test)
Main outcome variables
This Study Was To Determine The Effect Of Education And Counseling Through Cyberspace On The Self-efficacy And Continuity Of Breastfeeding In Nursing Mothers To Shahroud School Of Pregnancy. Accordingly, The Curriculum Included Face-to-Face Counseling,Telephony Tracking And Cybercafing In Order To UseThe Results Of A More Effective Educational ProgramTo Improve The Continuation Of Livelihood.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181208041889N1
Registration date: 2018-12-21, 1397/09/30
Registration timing: registered_while_recruiting

Last update: 2018-12-21, 1397/09/30
Update count: 0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Hamid Hojjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3222 5207
Email address
h_hojjati1362@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Training Through Cyberspace On The Self-efficacy And Continuation Of Lactation Primo Women.
Public title
The Effect of Education Through Cyberspace on The Effectiveness and Continuity of Breastfeeding in Primo women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People Tend To Participate In The Study. Minimum Level Of Education Is Read And Write. None Of The Subjects Studied In The Classroom Will Be Similar To Those Used In This Study. Access And Ability To Use Cyberspace. Pregnant Women. Condition Of Normal Baby (Normal Weight, Term Of Gestational Age, And Non-Abnormality Of The Baby). A medical Certificate For Breastfeeding Is Not For Mothers And Children.
Exclusion criteria:
Unwillingness To Continue Participating In The Study. Absenteeism At a 90-180 Minute Training Session Leave The virtual Lactation Training Group.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Random Unit: Individual No Layer No Randomization Tools
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: In The Intervention Group: - In The Control Group: Blind Main Researcher: In The Intervention Group: - In The Control Group: - Academic Researchers: In The Intervention Group: - In The Control Group: - Data Collection Authorities: In Intervention Group: - In Control Group: Blind Those Who Evaluate The Outcome: In The Intervention Group: -In The Control Group: Blind
Placebo
Not used
Assignment
Other
Other design features
This Study Does Not Require The Presence Of mother And Postpartum Education. Through The Virtual Group, Training And Answering Lactation Questions Are Being Conducted And a 25-Year-Old Experienced Lactation Expert Working In The Lactation Clinic Of The County Will Be Available To Assist Breastfeeding Mothers In The Presence Of Problem Lactation Mothers.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee in Chalous Unit Biological Research
Street address
No. 23, West 11, Moallem Street
City
Shahrood
Province
Semnan
Postal code
3613633978
Approval date
2018-12-10, 1397/09/19
Ethics committee reference number
1397.005.IR.IAU.CHALUS.REC

Health conditions studied

1

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

2

Description of health condition studied
The Effect Of Training Through Cyberspace On The Self-efficacy And Continuation Of Lactation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-efficacy Score Of Lactation Is Higher Than 54
Timepoint
Primiparous Women Participating In Pregnancy Classes In Weeks (28-34 Weeks) And 4 Months After Childbirth
Method of measurement
Self-efficacy Questionnaire For Lactation In Bandarva With 13 Items

2

Description
Continued Breastfeeding Score Above 60%
Timepoint
Primiparous Women Participating In Pregnancy Classes In Weeks (28-34 Weeks) And 4 Months After Childbirth
Method of measurement
Lactation Continuation Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Lactation Training 120-180 Minutes In Childbirth Classes And Membership And Submission Of Instructional Materials In The Virtual Lactation Group Until The End Of 4 Months
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Dr. Mojtaba Fouladi
Street address
22 Bahman Avenue, in front of the park of the Bahar Hospital
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3224 7648
Email
info@shmu.ac.ir
Web page address
http://www.shmu.ac.ir

2

Recruitment center
Name of recruitment center
Center For Preparing For Maternal Delivery
Full name of responsible person
Freshteh Miri
Street address
Ave. 22 Bahman, Noor Medical Complex, 1st floor
City
Shahrood
Province
Semnan
Postal code
3616614145
Phone
+98 23 3223 4610
Email
Sovashon2@gmail.com
Web page address
http://www.shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roholahe Samiei
Street address
Azad University Azad University
City
Ali Abad Catool
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Fax
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com
Web page address
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
Zeinab Heidari
Position
Masters Of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad University Of Aliabad
City
Ali Abade Catool
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
zheidarii2016@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeinab Heidari
Position
Masters Of Pediatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azad University Of Aliabad
City
Ali Abade Catool
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
zheidarii2016@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamide Hojatie
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Azad Islamic Azad UniversityAzad University
City
Golestan
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1392@yahoo.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
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
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