Protocol summary

Study aim
This study aims to evaluate the effectiveness of a transtheoretical model-based educational program in modifying fertility preferences and childbearing motivations among married students at Islamic Azad University, Isfahan (Khorasgan) Branch (2024).
Design
A randomized, non-blinded, parallel-group controlled clinical trial will be conducted on 60 married students. Block randomization will be used for allocation.
Settings and conduct
The study will be conducted at Islamic Azad University in Isfahan. The study population consists of married students. No blinding procedure will be implemented in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Voluntary participation consent; Ability to read and write in Persian; Currently married (legally or traditionally); Living with spouse at time of study. Exclusion criteria: Diagnosis of a chronic illness; any medical contraindication for childbearing.
Intervention groups
The intervention group will receive seven educational sessions on fertility preferences, childbearing motivations, and self-care based on the transtheoretical model, while the control group will only receive standard university education.
Main outcome variables
Reproductive preferences; childbearing motivations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250530065982N1
Registration date: 2025-07-06, 1404/04/15
Registration timing: prospective

Last update: 2025-07-06, 1404/04/15
Update count: 0
Registration date
2025-07-06, 1404/04/15
Registrant information
Name
Hedieh Kamrava
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
hediehkamrava1377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-12, 1404/04/21
Expected recruitment end date
2025-09-17, 1404/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of an Educational Program Based on the Transtheoretical Model on Fertility Preferences and Childbearing Motivations Among Married Students
Public title
The effect of educational programs on reproductive preferences and childbearing motivations
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Literacy (ability to read and write) Being married Living with one's spouse Age range: 18–35 years Using a contraceptive method No current or immediate future pregnancy planning
Exclusion criteria:
Diagnosis of a chronic illness Any medical contraindication for childbearing
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to either the intervention or control group. Each group consisted of 30 participants, and block randomization was employed for allocation. The blocking scheme included the following six permutations: CTTC, CTCT, CCTT, TCCT, TCTC, and TTCC, where "T" denotes the intervention group and "C" represents the control group. To generate the allocation sequence, random numbers between 0 and 6 were produced using the RANDBETWEEN function in Microsoft Excel. Based on the generated number, one of the predefined blocks was selected, and participants were allocated accordingly. This randomization method ensured equitable and systematic distribution of participants between the two groups, minimizing selection bias and enhancing the validity of the study.
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
Research Ethics Committees of Islamic Azad University-Yazd Branch
Street address
Shohadaye Gomnam boulevard, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2025-03-13, 1403/12/23
Ethics committee reference number
IR.IAU.YAZD.REC.1403.107

Health conditions studied

1

Description of health condition studied
Educational program based on a meta-theoretical model on reproductive preferences and childbearing motivations in married students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Individuals' desire and planning to have children
Timepoint
Before the start of the intervention, immediately after the intervention, 1 month after the start of the intervention, 3 months after the start of the intervention
Method of measurement
Childbearing Motivation Questionnaire

2

Description
The score each participant receives from the Fertility Preferences Questionnaire
Timepoint
Before the start of the intervention, immediately after the intervention, 1 month after the start of the intervention, 3 months after the start of the intervention
Method of measurement
Reproductive Preferences Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group participated in a 7-session educational program (1-2 hours per session) grounded in the Transtheoretical Model, designed to modify fertility preferences, enhance childbearing motivations, and promote self-care behaviors. Immediately following the intervention, both groups completed standardized questionnaires assessing fertility preferences and childbearing motivations. Follow-up evaluations were conducted at 1-month and 3-month intervals post-intervention to examine sustained effects. Participants requiring additional support received individualized counseling sessions, delivered either in-person or via telephone. Throughout the study period, the control group received only standard institutional education while undergoing identical assessment procedures at matching timepoints. This rigorous methodology ensured systematic evaluation of the intervention's effectiveness while maintaining ethical standards of participant care.
Category
Behavior

2

Description
Control group: This group didn't receive any new training and only received routine university training and classes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Isfahan (Khorasgan) Branch
Full name of responsible person
Dr. Payam Najafi
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah boulevard, Arqavanieh, Jey Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2219
Email
info@khuisf.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Ahmad Shajari
Street address
Islamic Azad University, Yazd Branch, Shohadaye Gomnam boulevard, Safaieh, Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 1000
Email
info@iauyazd.ac.ir
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
Hedieh Kamrava
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah boulevard, Arqavanieh, East Jey street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
Hediehkamrava1377@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mahsa sadat Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah boulevard, Arqavanieh, East Jey street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
mousavi1315@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hedieh Kamrava
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, Daneshgah boulevard, Arqavanieh, East Jey street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
Hediehkamrava1377@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All study data will be made shareable after complete de-identification of participants.
When the data will become available and for how long
The access period begins 6 months after the results are published.
To whom data/document is available
Researchers
Under which criteria data/document could be used
By citing a logical reason, citing the source, and conducting analyses.
From where data/document is obtainable
Researchers may request the data by contacting Dr. Mahsa Al-Sadat Mousavi via email: mousavi1315@gmail.com
What processes are involved for a request to access data/document
Following a 6-month post-publication period, data may be obtained by submitting a formal request with valid justification to the corresponding author, Dr. Mahsa Al-Sadat Mousavi. Approved requests will be fulfilled within 10 business days.
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