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The Effect of Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women

Protocol summary

Study aim
Determining the Effect of a Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women
Design
Semi-experimental clinical trial; intervention and control groups; non-blinded; stratified random allocation; 70 participants per group; 12 health centers across three socioeconomic levels (four per stratum), two centers for intervention and two for control.
Settings and conduct
This semi-experimental trial will be conducted in Zanjan among married women aged 18–45 with one child. Participants from 12 health centers will be selected by socioeconomic status and randomly assigned to intervention or control groups. Eligible individuals will be identified via the "Sib" system. The educational intervention, based on the Theory of Planned Behavior, will include six online sessions with short videos and virtual groups for interaction.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Iranian nationality, residence in Zanjan, literacy, married women aged 18–45, one child (≥1 year, 11 months, 29 days), access to phone or computer with Telegram and Bale, pre-contemplation or contemplation stage. Exclusion Criteria: More than one child, pregnancy, infertility history or diagnosis, medical contraindication to pregnancy, major psychiatric disorder, permanent contraception, participation in similar programs in past six months, severe physical or mental illness.
Intervention groups
In the experimental group, virtual training is delivered over six sessions via messaging platforms, with each session containing one or two pre-recorded educational videos of up to 15 minutes. In the control group, participants can only contact the researcher to ask midwifery-related questions to encourage participation.
Main outcome variables
Attitude, subjective norm, perceived behavioral control, and intention toward childbearing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N18
Registration date: 2025-12-16, 1404/09/25
Registration timing: prospective

Last update: 2025-12-16, 1404/09/25
Update count: 0
Registration date
2025-12-16, 1404/09/25
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
recruiting
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women
Public title
The Effect of Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian citizenship Residing in the city of Zanjan Being literate in reading and writing Married women aged 18 to 45 years Having only one child whose minimum age is 1 year, 11 months, and 29 days Having access to a mobile phone or computer capable of installing and using the Telegram and Bale messaging apps until the end of the study Being in the precontemplation or contemplation stage according to the Stages of Change model
Exclusion criteria:
Having more than one child Being pregnant at the time of enrollment in the study Having a history or diagnosis of infertility in the woman or her husband Having a medical contraindication to pregnancy Having a major psychiatric disorder (based on self-report) Using permanent contraceptive methods (such as tubal ligation or vasectomy) Participation in similar educational programs within the past six months Having severe physical or mental illnesses that impede understanding the training or making informed decisions
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Health centers in Zanjan were stratified into three economic levels: high, medium, and low. Four centers were selected from each stratum. Allocation of centers to the intervention and control groups was performed using simple randomization, with two centers from each stratum assigned to the intervention group and two to the control group. Eligible participants were then identified from the “SIB” database, and written informed consent was obtained electronically. Participant recruitment continued continuously and proportionally within each center until the target sample size was achieved.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery-Iran University of Medical Sciences
Street address
Hemmat Highway - next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-10-13, 1404/07/21
Ethics committee reference number
IR.IUMS.NURSE.REC.1404.007

Health conditions studied

1

Description of health condition studied
Management and planning of fertility and procreation
ICD-10 code
Z31
ICD-10 code description
Encounter for procreative management

Primary outcomes

1

Description
Attitude toward childbearing
Timepoint
At three time points, including before the start of the interventions (at the beginning of the study), immediately after the sessions related to each theoretical construct, and two months after the intervention.
Method of measurement
Theory of Planned Behavior Questionnaire

2

Description
Subjective norm toward childbearing
Timepoint
At three time points, including before the start of the interventions (at the beginning of the study), immediately after the sessions related to each theoretical construct, and two months after the intervention.
Method of measurement
Theory of Planned Behavior Questionnaire

3

Description
Perceived behavioral control toward childbearing
Timepoint
At three time points, including before the start of the interventions (at the beginning of the study), immediately after the sessions related to each theoretical construct, and two months after the intervention.
Method of measurement
Theory of Planned Behavior Questionnaire

4

Description
Childbearing intention
Timepoint
At the beginning of the study, to identify eligible participants (in the precontemplation or contemplation stages), and at the end of the study, to assess the extent of participants’ progress to higher stages of childbearing.
Method of measurement
Stages of Change Model Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This study is a semi-experimental clinical trial with two groups (intervention and control) designed to determine the effect of virtual education based on the Theory of Planned Behavior (TPB) on fertility intention among women with only one child. After approval of the proposal and obtaining ethical clearance from the university ethics committee, an official letter will be obtained to conduct the study in urban comprehensive health centers. The study setting will include urban comprehensive health centers under the coverage of the university. The target population consists of married women aged 18 to 45 years who have only one child and reside in Zanjan.Inclusion criteria are Iranian nationality, continuous residence in Zanjan, having only one child aged at least one year and 11 months, minimum literacy skills, and being in the pre-contemplation or contemplation stage according to the Transtheoretical Model (TTM) questionnaire. Exclusion criteria include having more than one child, being pregnant at the time of enrollment, lacking intention for a second child, history or diagnosis of infertility, medical contraindication to pregnancy, major psychiatric disorders, use of permanent contraceptive methods, participation in similar educational programs in the past six months, and severe physical or mental conditions that prevent comprehension of the education or informed decision-making. Criteria for withdrawal from the study include unwillingness to continue participation, absence from more than one educational session, pregnancy during the study, experiencing severe stressful events, major family conflicts, and diagnosis of infertility or chronic or mental illnesses preventing pregnancy.The sampling method involves selecting 12 centers from a total of 19 urban comprehensive health centers in Zanjan, classified into three socioeconomic levels (high, medium, low). Four centers from each level will be selected, with two centers randomly assigned to the intervention group and two to the control group. Eligible women’s information will be extracted from the database and they will be invited by phone to participate in the study. Written consent will be obtained virtually, and sampling will continue until the target sample size of 70 participants per group (considering potential attrition) is achieved.Random allocation of clusters will prevent contamination between groups and maintain internal validity. Due to the nature of the intervention, blinding of participants and center staff is not feasible; however, data management will be conducted confidentially. Data collection will occur within a specified timeframe and data analysis will follow the CONSORT guidelines for interventional studies.The educational intervention will be structured based on the four components of the TPB and delivered in six virtual sessions through dedicated messaging groups. Each component will be covered in two sessions to ensure comprehensive content delivery and effectiveness. Each session will include one or two pre-recorded educational videos of up to 15 minutes, and virtual groups will facilitate interaction, Q&A, and experience sharing.The educational sessions are structured as follows:Session 1 (Attitude – Part 1): Positive effects of having children, benefits of multiple children, pregnancy, natural childbirth, and breastfeeding.Session 2 (Attitude – Part 2): Adverse effects of having a single child, side effects of contraceptive methods, and abortion consequences.Session 3 (Subjective Norm – Part 1): Addressing medical and educational misconceptions regarding fertility.Session 4 (Subjective Norm – Part 2): Addressing economic misconceptions, analyzing national population aspects, and highlighting maternal dignity.Session 5 (Perceived Behavioral Control): Teaching life skills and informed decision-making, introducing social support, and reviewing challenges and strategies to overcome fertility barriers.Session 6 (Behavioral Intention): Planning for childbearing, addressing remaining concerns, and reinforcing intentional and informed commitment.Data collection tools include three validated questionnaires:Demographic and reproductive health questionnaire, adapted from the official Ministry of Health form, used to collect baseline descriptive data.Transtheoretical Model (TTM) questionnaire to assess participants’ stage (pre-contemplation, contemplation, preparation, action, or maintenance), completed at baseline and at the end of the study.Theory of Planned Behavior (TPB) questionnaire to assess attitude, subjective norm, perceived behavioral control, and fertility intention, completed at three time points: before the intervention, immediately after each session, and two months post-intervention.
Category
Behavior

2

Description
Control group: Participants in the control group will not receive this educational program. Their contact with the researcher will only be facilitated to encourage participation in the study and to answer couples’ questions regarding midwifery.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Urban Health Services Center No. 1
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Adjacent To Zanjan County Health Center, Amirkabir Intersection, Imam Street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3326 0154
Email
f.mojtabazadeh@outlook.com

2

Recruitment center
Name of recruitment center
Urban Health Services Center No. 3
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Sosan Alimoradian Comprehensive Health Center, Beginning Of Saadi North Street, Saadi Intersection, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3425 1805
Email
f.mojtabazadeh@outlook.com

3

Recruitment center
Name of recruitment center
Urban Health Services Center No. 5
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Zolfaghari Street, Sarcheshmeh Saadi Vassat Neighborhood, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3336 2025
Email
f.mojtabazadeh@outlook.com

4

Recruitment center
Name of recruitment center
Urban Health Services Center No. 6
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Near Municipality Executive Office, Shahid Hossein Hassani Street, Ayatollah Sadooghi Shomali Street, Eslam Abad Neighborhood, Janbazan Town, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3352 5102
Email
f.mojtabazadeh@outlook.com

5

Recruitment center
Name of recruitment center
Urban Health Services Center No. 7
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Between Ahmad Takhti Alley and Farshad Abbasi Alley, Corner of 9th Gharbi Etemadieh Street, Jomhouri Eslami Street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3342 0067
Email
f.mojtabazadeh@outlook.com

6

Recruitment center
Name of recruitment center
Urban Health Services Center No. 9
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Ahmad Mahdavi Health Center, Between Shahpour Esmaeili Alley and Honarju Alley, Fateh Street, Honarestan Neighborhood, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3377 2610
Email
f.mojtabazadeh@outlook.com

7

Recruitment center
Name of recruitment center
Urban Health Services Center No. 10
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Opposite Ansar Bank, Parvin Alley, Mohammadiyeh Square, Jomhouri Eslami Street, Southern Side of Sheikh Fazlollah Nouri Street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3345 7015
Email
f.mojtabazadeh@outlook.com

8

Recruitment center
Name of recruitment center
Urban Health Services Center No. 11
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
2nd Floor, University of Applied Science and Technology, Next to Gas Station, 45 Metri Golshahr Street, Golshahr Neighborhood, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 992 963 5114
Email
f.mojtabazadeh@outlook.com

9

Recruitment center
Name of recruitment center
Urban Health Services Center No. 13
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Opposite Ghaem Honarestan, Near Palestine Boulevard, Khayyam Street, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3336 1804
Email
f.mojtabazadeh@outlook.com

10

Recruitment center
Name of recruitment center
Urban Health Services Center No. 14
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
4th West Street, Phase 2, Karmandan Town, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3344 7054
Email
f.mojtabazadeh@outlook.com

11

Recruitment center
Name of recruitment center
Urban Health Services Center No. 15
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
1st Yasaman Street, Yasaman Street, Golha Square, Farhang Neighborhood, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3353 3660
Email
f.mojtabazadeh@outlook.com

12

Recruitment center
Name of recruitment center
Urban Health Services Center No. 17
Full name of responsible person
Fatemeh Mojtabazadeh-Hasanloei
Street address
Plot 5792, Next to Vali Asr Mosque, Eqbal 3 Alley, Erfan Street, Mirza Shirazi Boulevard, Amir Kabir Square, Amir Kabir Town, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514937117
Phone
+98 24 3376 4144
Email
f.mojtabazadeh@outlook.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
info@iums.ac.ir
Web page address
https://iums.ac.ir/
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
Leila Amiri Farahani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
l.amirifarahani1100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
l.amirifarahani1100@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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
l.amirifarahani1100@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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