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IRCT20171007036615N14 IRCT 2025-10-21 Tabriz University of Medical Sciences The Effect of Theory-Based Virtual Education on Health Literacy and Cervical Cancer Screening Behavior The Effect of Virtual Education Based on the Fogg Model on Health Literacy and Stages of Behavior Change in Cervical Cancer Screening in Women: A Randomized Controlled Clinical Trial 2025-11-06 anticipated 80 Complete https://irct.ir/trial/86293 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: The study will include 80 participants, who will be allocated to either the intervention or control group by a person not involved in sampling, using random block allocation with the Random Allocation Software (RAS), employing blocks of 4 and 6 with a 1:1 ratio. The allocation will be written on paper and placed in sequentially numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in the order of participants' entry into the study, Blinding description: The outcome assessor and data analyst in this study will be blinded to the allocation of participants to the groups. The initial outcome assessment before randomization will be conducted by the principal investigator (who administers the intervention). However, the outcome evaluation and data analysis will be performed by other individuals not involved in participant allocation, sampling, or intervention administration. N/A Cervical cancer. Intervention 1: Intervention Group: The intervention group will receive virtual education regarding cervical cancer and its screening. The content of the virtual intervention will be based on scientific evidence and aligned with the components of the Fogg Behavior Model, which includes videos (each video maximum two minutes), recorded audio (each recorded audio maximum two minutes), written messages, quizzes (simple written messages but in the form of questions and answers), and images containing educational messages (infographics). The main content titles are: the prevalence of cervical cancer in Iran and the world, the progression of the disease towards cancer, danger signs, ways to prevent cervical cancer and introduction of Pap smear, HPV test and available vaccines, guidelines of the Iranian Ministry of Health and the American College of Obstetricians and Gynecologists for screening. Following preparation, the content will be uploaded to a dedicated channel in the Eitaa messaging application. The intervention will be provided for 4 weeks; 2 times a week (every week on Mondays and Thursdays at 5 pm) along with reminders 2-3 times a week. In each content upload, a combination of the aforementioned formats will be used. Reminders will be delivered via SMS and phone calls. Immediately after uploading the materials, an initial SMS will be sent to participants, informing them of the upload and encouraging them to study the content. Participants will be requested to provide feedback by sending a private message with a 'like' symbol to the researcher once they have reviewed the materials. Additionally, if participants have any questions about the materials posted in the channel, they will receive the necessary guidance. In case of no feedback from the participant until 24 hours after uploading the materials, a second reminder SMS will be sent. In case of no feedback again until 48 hours, a phone call will be made to the participant. Intervention 2: Control group: The control group will not receive any intervention. Yes - There is a plan to make this available What will be shared: Part of the data related to the study outcomes will be available for sharing. When: Access period starts 6 months after the results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: De-identified data available for meta-analysis or replication studies, with approval from the principal investigator. Where to obtain: By sending an email to the email address of Dr. Esmat Mehrabie: b.mehrabi62@gmail.com How to obtain: Emails sent by applicants to Dr. Esmat Mehrabi's email address (b.mehrabi62@gmail.com) will be responded to within one week. Comments:
public Saba Mousavi-Nejad
School of Nursing & Midwifery, South Shariati St.,Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 sabamnj@gmail.com Tabriz University of Medical Sciences scientific Dr. Esmat Mehrabi
School of Nursing and Midwifery, South Shariati St., Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 0364 b.mehrabi62@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Married women aged 21 to 65 years No history of Pap smear in the past three years or no intention to undergo it in the next six months No personal history of cervical cancer or history of cervical cancer in first-degree relatives Possession of a smartphone Minimum education level of middle school Verbal and auditory abilities, and the ability to use mobile applications Scoring less than 99 on the Cervical Cancer Health Literacy Questionnaire 21 years 65 years Female Pregnant women History of post-coital bleeding or irregular uterine bleeding Self-reported history of genital warts Current participation in related educational programs History of atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion, or high-grade squamous intraepithelial lesion History of hysterectomy C53 Malignant neoplasm of cervix uteri Behavior N/A Intervention Group: The intervention group will receive virtual education regarding cervical cancer and its screening. The content of the virtual intervention will be based on scientific evidence and aligned with the components of the Fogg Behavior Model, which includes videos (each video maximum two minutes), recorded audio (each recorded audio maximum two minutes), written messages, quizzes (simple written messages but in the form of questions and answers), and images containing educational messages (infographics). The main content titles are: the prevalence of cervical cancer in Iran and the world, the progression of the disease towards cancer, danger signs, ways to prevent cervical cancer and introduction of Pap smear, HPV test and available vaccines, guidelines of the Iranian Ministry of Health and the American College of Obstetricians and Gynecologists for screening. Following preparation, the content will be uploaded to a dedicated channel in the Eitaa messaging application. The intervention will be provided for 4 weeks; 2 times a week (every week on Mondays and Thursdays at 5 pm) along with reminders 2-3 times a week. In each content upload, a combination of the aforementioned formats will be used. Reminders will be delivered via SMS and phone calls. Immediately after uploading the materials, an initial SMS will be sent to participants, informing them of the upload and encouraging them to study the content. Participants will be requested to provide feedback by sending a private message with a 'like' symbol to the researcher once they have reviewed the materials. Additionally, if participants have any questions about the materials posted in the channel, they will receive the necessary guidance. In case of no feedback from the participant until 24 hours after uploading the materials, a second reminder SMS will be sent. In case of no feedback again until 48 hours, a phone call will be made to the participant. Control group: The control group will not receive any intervention. Cervical cancer health literacy score. Timepoint: before the intervention and 4 weeks after the completion of the intervention. Method of measurement: Cervical Cancer Health Literacy Questionnaire by Bazaz et al. (2019). Frequency of stages of behavioral change for cervical cancer screening. Timepoint: before the intervention and 8 weeks after the completion of the intervention. Method of measurement: Behavioral Change Stages Checklist (Prochaska). Decision-making self-efficacy score. Timepoint: before the intervention and 4 weeks after the completion of the intervention. Method of measurement: Decision Self-Efficacy scale. Anxiety score. Timepoint: before the intervention and 4 weeks after the completion of the intervention. Method of measurement: Spielberger State Anxiety Inventory (Form 1). Tabriz University of Medical Sciences Approved 2025-09-08 Ethics Committee of Tabriz University of Medical Sciences Central Building, Tabriz University of Medical Sciences, Golgasht St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)