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IRCT20180427039436N18 IRCT 2025-12-16 Iran University of Medical Sciences The Effect of Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women The Effect of Virtual Education Program Based on the Theory of Planned Behavior on Childbearing Intentions among Single-Child's Women 2026-01-21 anticipated 140 Recruiting https://irct.ir/trial/87710 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, 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. N/A Management and planning of fertility and procreation. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Leila Amiri Farahani
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 l.amirifarahani1100@gmail.com Iran University of Medical Sciences scientific Leila Amiri Farahani
In front of Khatamol anbiaa Hospital., Rashid Yasemi Ave., Valiasr Ave., Tehran., Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 l.amirifarahani1100@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 45 years Female 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 Z31 Encounter for procreative management Behavior N/A 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. 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. 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. 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. 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. 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. Iran University of Medical Sciences Approved 2025-10-13 Research Ethics Committees of School of Nursing and Midwifery-Iran University of Medical Sciences Hemmat Highway - next to Milad Tower Tehran Tehran Iran (Islamic Republic of)