Protocol summary

Study aim
Development, implementation, and assessment of a childbearing education program based on the theory of planned behavior for couples preparing for marriage in Hamadan city.
Design
Clinical trial with control group, with parallel groups
Settings and conduct
Participants were randomly divided into two groups of 64: an intervention group and a control group. This study will take place in comprehensive health service centers in Hamadan.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study were as follows: participants must be willing to participate, aged between 15 and 49 years, and officially married couples. Exclusion criteria included incomplete responses to the questionnaires.
Intervention groups
The intervention group will participate in four educational sessions that will take place one week apart at the Hamedan Comprehensive Health Center. Each session will last between 45 and 60 minutes. Four weeks after the completion of these sessions, the questionnaires will be administered again. It is important to note that once the study is finished, all educational materials will also be provided to the control group.
Main outcome variables
Attitudes towards childbearing, abstract norms, perceived behavioral control, and behavioral intentions.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180707040370N13
Registration date: 2025-03-17, 1403/12/27
Registration timing: prospective

Last update: 2025-03-17, 1403/12/27
Update count: 0
Registration date
2025-03-17, 1403/12/27
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-10, 1404/03/20
Expected recruitment end date
2026-05-20, 1405/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and implementing an educational program for the desire to childbearing based on the theory of planned behavior in couples on the eve of marriage in Hamadan city
Public title
Designing and implementing an educational program for the desire to childbearing based on the theory of planned behavior in couples on the eve of marriage
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age must be between 15 and 49 years Must be willing to participate in the study Participants must be in a formal marriage with their partner
Exclusion criteria:
Age
From 15 years old to 49 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
To determine the sequence of allocation, a random block design method is employed. Using web-based software, we create 4-item AABB blocks to establish the sequence. The type of intervention is placed inside opaque, sealed envelopes, which are then numbered in order. Each couple receives an envelope based on their order of entry into the study and is assigned to either the intervention group or the control group depending on the contents of the envelope.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.UMSHA.REC.1403.887

Health conditions studied

1

Description of health condition studied
Attitudes towards childbearing, abstract norms, perceived behavioral control, and behavioral intentions.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attitudes towards childbearing
Timepoint
Before the intervention and 4 weeks after the completion of the sessions
Method of measurement
Fertility and Childbearing Attitude Questionnaire

2

Description
abstract norms
Timepoint
Before the intervention and 4 weeks after the completion of the sessions
Method of measurement
Fertility and Childbearing Attitude Questionnaire

3

Description
perceived behavioral control
Timepoint
Before the intervention and 4 weeks after the completion of the sessions
Method of measurement
Fertility and Childbearing Attitude Questionnaire

4

Description
behavioral intentions
Timepoint
Before the intervention and 4 weeks after the completion of the sessions
Method of measurement
Fertility and Childbearing Attitude Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will attend four educational sessions. These sessions will be held weekly at the Hamedan Comprehensive Health Center. Each session will last between 45 and 60 minutes.
Category
Behavior

2

Description
Control group: Participants in the control group do not receive any training.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Shohada
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Shohada., Takhti Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838344
Phone
+98 81 3252 4321
Email
en.jenabi@yahoo.com

2

Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Khezr
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Khezr., Khezr Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838289
Phone
+98 81 3266 0550
Email
Khezr.Health@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
arsoltanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data analysis is permitted with the author's permission.
From where data/document is obtainable
Hamadan ،Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Responsible person: Ensiyeh Jenabi Postal code: 6517838695 Phone number: +98 81 3838 0496 Email: en.jenabi@yahoo.com
What processes are involved for a request to access data/document
Requests should be submitted to the corresponding author via email. He will follow up with the inquiry
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