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Comparison of the Effect of prenatal care education on spouses of primiparous women, in face-to-face and social network based on Pregnancy Experience and Fear of Child Birth

Protocol summary

Study aim
Comparison of the Effect of prenatal care education on spouses of primiparous women, in face-to-face and social network based on Pregnancy Experience and Fear of Child Birth
Design
Semi experimental study , with two parallel groups design of 76 patients
Settings and conduct
This study will be conducted in the perinatal clinic of the Milad Hospital. Educational content at the first session of nutrition during pregnancy (weeks 24-28), second session of fetal growth and development and mental health and preparation for motherhood and fatherhood (parental role) (weeks 28-30), third session of the benefits and disadvantages of normal delivery, cesarean section, analgesics and pain relief Childbirth, delivery method selection, delivery planning (weeks 33-32), fourth session of baby care and neonatal symptoms (Week 37). In the first intervention group, the spouses of primiparous women, receive educational content through the telegram software, in four sessions. The educational content is according to country standard instructions. In addition, sending messages 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.In the second intervention group, the spouses of primiparous women, receive educational content through face to face, in four sessions.
Participants/Inclusion and exclusion criteria
Nulliparous women eligible to receive common perinatal cares
Intervention groups
In this study, participants will assign to one of tow groups: intervention group 1 (education based on social networking (on Telegram)), intervention group 2 (face to face childbirth preparation classes) .
Main outcome variables
Pregnancy experience; Delivery expectancy/experience;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N4
Registration date: 2019-07-14, 1398/04/23
Registration timing: prospective

Last update: 2019-07-14, 1398/04/23
Update count: 0
Registration date
2019-07-14, 1398/04/23
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
2019-08-06, 1398/05/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of prenatal care education on spouses of primiparous women, in face-to-face and social network based on Pregnancy Experience and Fear of Child Birth
Public title
prenatal care education on spouses of primiparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria for mothers: Iranian nationality Women aged 35-18 primiparous women with gestational age of 20 weeks being literate for reading and writing singleton pregnancy and low risk pregnancy No history of infertility Participate in childbirth preparation classes Not having a history of any physical, psychological disease, addiction to cigarettes, alcohol and psychotropic substances according to self report. Inclusion Criteria for fathers: First experience of fatherhood At least 18 years old Iranian nationality Having a common home and living with a spouse being literate for reading and writing Having a mobile phone or a computer with the ability to install the telegram application until the end of the study Not having a history of any physical, psychological disease, addiction to cigarettes, alcohol and psychotropic substances according to self report. No bad event since three months before the intervention
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
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
N/A
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
Hemat Highway next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.IUMS.REC.1398.325

Health conditions studied

1

Description of health condition studied
Virtual education and face to face education of prenatal care
ICD-10 code
ICD-10 code description

Primary outcomes

1

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

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 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 learning group:In this group, the spouses of primiparous women, receive educational content through face to face, in four sessions.Educational content at the first session of nutrition during pregnancy (weeks 24-28), second session of fetal growth and development and mental health and preparation for motherhood and fatherhood (parental role) (weeks 28-30), third session of the benefits and disadvantages of normal delivery, cesarean section, analgesics and pain relief Childbirth, delivery method selection, delivery planning (weeks 33-32), fourth session of baby care and neonatal symptoms (Week 37).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Zari Dolatabadi Takabi
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

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
Zari Dolatabadi Takabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
DOLATABADI.Z@IUMS.AC.IR

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zari Dolatabadi Takabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid Yasemi St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
DOLATABADI.Z@IUMS.AC.IR

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 St
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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