Protocol summary

Summary
Aim: Investigating the effect of educational intervention based on the Theory of Planned Behavior on women’s intention for childbearing Study design: Controlled randomized clinical trial Inclusion criteria: referring to premarital consulting centers for premarital tests; having Iranian nationality; marrying for the first time; having at least a high school degree; being aged from 20 to 35 years old; living in Tehran Exclusion criteria: not participating in both of the educational sessions; unwillingness to continue the study Sample size: The study will be conducted on 150 women Intervention: Two 90-minute educational sessions based on the Theory of Planned Behavior with one day interval

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030526911N1
Registration date: 2017-05-28, 1396/03/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Seyedeh Sara Baki Hashemi
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 13 3377 1362
Email address
s.baki.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on the Theory of Planned Behavior on women's intention for childbearing
Public title
Investigating the effect of education based on the Theory of Planned Behavior on women's intention for childbearing: A clinical trial
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: referring to premarital consulting centers for premarital tests; having Iranian nationality; marrying for the first time; having at least a high school degree; being aged from 20 to 35 years old; living in Tehran Exclusion criteria: not participating in both of the educational sessions; unwillingness to continue the study
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization for this study was conducted using the table of random numbers.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjou Boulevard, Evin
City
Tehran
Postal code
Approval date
2015-12-14, 1394/09/23
Ethics committee reference number
IR.sbmu.PHNM.1394.231

Health conditions studied

1

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

Primary outcomes

1

Description
Awareness
Timepoint
Before the intervention; 6 weeks after the intervention
Method of measurement
Questionnaire

2

Description
Attitude
Timepoint
Before the intervention; 6 weeks after the intervention
Method of measurement
Questionnaire

3

Description
Subjective norm
Timepoint
Before the intervention; 6 weeks after the intervention
Method of measurement
Questionnaire

4

Description
Perceived Behavioral Control
Timepoint
Before the intervention; 6 weeks after the intervention
Method of measurement
Questionnaire

5

Description
Intention
Timepoint
Before the intervention; 6 weeks after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: For this group, two 90-minute educational sessions with one day interval will be conducted. Besides the routine premarital educations, this group will receive an educational content based on the Theory of Planned Behavior. Speech, group discussion, questions and answers and pamphlets will be used.
Category
Other

2

Description
Control group: This group will only receive the routine premarital educations.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hashemi Nejad Premarital Counseling Center
Full name of responsible person
Dr. Haleh Ahmadnia
Street address
Next to the Isaar pharmacy, Aminolmolk street, Ghopan junction, Ghazvin street
City
Tehran

2

Recruitment center
Name of recruitment center
Khajeh Noori Premarital Counseling Center
Full name of responsible person
Dr. Zarrin Gholi
Street address
No. 67 , Opposite of the Electricity Office, Shahid Moshki Street, Darvazeh Shemiran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Seyedeh Sara Baki Hashemi
Street address
Nyayesh Intersection, Valiasr Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University
Full name of responsible person
Seyedeh Sara Baki Hashemi
Position
Master student in Midwifery
Other areas of specialty/work
Street address
Nyayesh Intersection, Valiasr Street
City
Tehran
Postal code
Phone
+98 13 3377 1362
Fax
Email
s.baki257@gmail.com; baki.hashemi257@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University
Full name of responsible person
Noorosadat Kariman
Position
PHD in reproductive health
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
n_kariman@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Behehshti University
Full name of responsible person
Seyedeh Sara Baki Hashemi
Position
Master student in Midwifery
Other areas of specialty/work
Street address
Nyayesh Intersection, Valiasr Street
City
Tehran
Postal code
Phone
+98 13 3377 1362
Fax
Email
baki.hashemi257@gmail.com;s.baki257@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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