Protocol summary

Study aim
Comparing the Effect of Childbirth Education based on Face to Face and the Social Network on Pregnancy and Delivery Experience and Type of Delivery on Pregnant Women
Design
Semi experimental study with control group, with three parallel groups design of 165 patients
Settings and conduct
This study will be conducted in the perinatal clinic of the Milad Hospital. The educational content is according to country standard instructions. In addition, sending messages based on Mayer's multimedia in form of text, image, podcast and video cast, in the MPEG-4 format. The maximum of films time was 10-15 minute. To prevent from being uploaded, as well as reduction in educational quality, the content of each session in divided sections in that session and specific time will be sent every day. To make sure of correct methods education of respiratory and relaxation techniques, two sessions to practice will be hell in the hospital.
Participants/Inclusion and exclusion criteria
Nulliparous women are eligible to receive common perinatal cares
Intervention groups
In this study, participants will assign to one of three groups: intervention group 1 (education based on social networking (on Telegram)), intervention group 2 (face to face childbirth preparation classes) and control group (Not attending any educational course.
Main outcome variables
Pregnancy experience; Delivery expectancy/experience; Desire to type of delivery; Type of delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N2
Registration date: 2018-06-15, 1397/03/25
Registration timing: prospective

Last update: 2018-06-15, 1397/03/25
Update count: 0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Childbirth Education based on Face to Face and the Social Network on Pregnancy and Delivery Experience and Type of Delivery on Pregnant Women
Public title
Effect of virtual Childbirth Education on pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality nullipara 18-35 years old 20 week of gestational age Literate Having a mobile phone or computer with the ability to install a telegram program until the end of the study Active Internet access Absence of high risk pregnancy Lack of history of infertility and psychological disorder
Exclusion criteria:
Being absent more than two sessions of childbirth classes Leave the group Not responding to messages sent by the researcher for at least one week during the study Indication of high risk pregnancy during study Preterm labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 165
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Iran University of Medical Sciences
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.IUMS.REC 1396.9511373011

Health conditions studied

1

Description of health condition studied
Virtual education of childbirth preparation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pregnancy experience
Timepoint
Before intervention at 16-20 weeks gestational and 36-38 weeks of gestational age
Method of measurement
Brief version of pregnancy experience scale

2

Description
delivery expectancy/experience questionnaire
Timepoint
Before intervention at 16-20 weeks gestational and 36-38 weeks of gestational age
Method of measurement
Wijma delivery expectancy/experience questionnaire

3

Description
Type of delivery
Timepoint
After delivery
Method of measurement
Question based on social networking

Secondary outcomes

empty

Intervention groups

1

Description
Education based on social networking (on Telegram): The educational content is according to country standard instructions. In addition, sending messages based on Mayer's multimedia in form of text, image, podcast, video cast, in the MPEG-4 format. The maximum of films time will be 10-15 minute.
Category
Other

2

Description
Face to face childbirth preparation classes: These classes will be held at the hospital in 8 sessions.
Category
Other

3

Description
Control group: Not attending any educational course
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Robab Mousavi
Street address
Shahid Hemmat highway, District 2
City
Tehran
Province
Tehran
Postal code
881/14665
Phone
+98 21 84090
Fax
+98 21 8806 2005
Email
info@miladhospital.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Shahid Hemmat highway, District 2
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9024
Fax
+98 21 8805 2248
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Robab Mousavi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
rrr.mousavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Robab Mousavi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
rrr.mousavi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
l.amirifarahani@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
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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