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IRCT20250522065849N1 IRCT 2025-08-24 Islamic Azad University the effect of digital storytelling on students' knowledge and attitude toward hpv and its vaccination The Effect of Digital Storytelling-Based Education on Knowledge and Attitudes of Non-Medical Students Toward Human Papillomavirus (HPV) and Its Vaccination 2025-09-12 anticipated 210 Complete https://irct.ir/trial/83745 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study uses computer-generated block randomization. Two non-medical faculties of Islamic Azad University, Karaj, are purposively selected; classroom recruitment follows eligibility screening and written informed consent. Participants are stratified into four strata by sex (female/male) and semester (lower [1–4]/upper ≥5) and, within each stratum, allocated 1:1:1 to intervention, active control, or passive control using variable block sizes of 6 and 9. Randomization lists are generated on randomizer.org by an independent person, with allocation concealed via sequentially numbered, opaque, sealed envelopes (SNOSE) opened at enrollment; to offset ≈10% attrition, each stratum’s target is increased and rounded to the nearest multiple of 9. • Female, lower semester: N=54 (18/18/18), block sizes: 6 & 9; e.g., 6×9-person blocks (3/3/3). • Female, upper semester: N=51 (17/17/17), block sizes: 6 & 9; e.g., 3×9 + 4×6 blocks (3/3/3 and 2/2/2). • Male, lower semester: N=54 (18/18/18), block sizes: 6 & 9; e.g., 6×9. • Male, upper semester: N=51 (17/17/17), block sizes: 6 & 9; e.g., 3×9 + 4×6. (Total N=210; per 6-person block: 2 per arm; per 9-person block: 3 per arm.), Blinding description: This is a single-blind, assessor-blinded trial. Participants cannot be fully blinded due to the obvious nature of the interventions (digital storytelling, traditional lecture, or no intervention). However, outcome assessors who collect and code pre-test, post-test, and follow-up questionnaires will be blinded to group allocation. Implementation: Each participant will receive a unique numeric ID upon enrollment; only the allocation manager will know the corresponding group. The intervention delivery team is responsible for providing the educational content but has no role in data analysis. The data collection team will only see participant codes and will have no access to group allocation. The allocation list will be stored in a password-protected file and will only be opened after data collection is complete. Data analysis will be performed by a statistician blinded to group assignments, with group labels revealed only at the final analysis stage. N/A Human papillomavirus. Intervention 1: Intervention Group 1: Digital Storytelling-Based Education; This group will participate in a two-week educational program consisting of four sessions (two sessions per week). Each session includes the presentation of a 5-minute educational video based on real-life stories and scientifically validated information about Human Papillomavirus (HPV) and its vaccination. The videos will be delivered via secure online platforms or privacy-adjusted messaging applications.After watching each video, a 20-minute live online session will be held, led by the researcher, for Q&A, clarification, and discussion.Equipment and software used include InShot for video editing, Audacity for voice recording and editing, and standard audio-visual recording tools. All educational content will be reviewed and approved by two nursing and midwifery faculty members prior to implementation. The total duration of the intervention for each participant will be two weeks. Intervention 2: Intervention Group 2 (Active Control): Traditional EducationThis group will attend a single, in-person, 2-hour educational session. The training will include PowerPoint presentations, educational images, and verbal explanations covering HPV, its transmission, complications, and the importance of vaccination. At the end of the session, a 20-minute Q&A segment will be conducted face-to-face. Additionally, a printed educational pamphlet containing scientifically validated information will be provided to participants.Educational tools include projector, laptop, PowerPoint presentation, and printed pamphlets. The entire intervention for this group will be delivered in one single session. Intervention 3: Control Group (No Intervention): Participants in this group will receive no training or intervention during the study period. Only after completing the post-test will they be provided with an educational pamphlet similar to the active control group, in order to increase their awareness. This measure is intended to adhere to ethical principles and ensure all participants have access to scientifically accurate information. Yes - There is a plan to make this available What will be shared: General Data Sharing Plan: In alignment with ICMJE’s ethical principles and in recognition of participants’ contributions, we plan to share study-related materials. These will be available after study completion and data analysis for up to five years. Data to be shared: Individual Participant Data (IPD): Yes De-identified participant data will be shared upon formal request and ethics approval. Study Protocol: Yes Available upon request for research or educational purposes. Statistical Analysis Plan: Yes Includes test types, software used, and variable definitions in PDF. Informed Consent Form: Yes A de-identified version will be made available. Clinical Study Report: Yes A comprehensive report will be shared post-analysis. Analysis Codes: Yes SPSS or other statistical software codes with documentation will be shared. Data Dictionary: Yes Includes definitions and coding of all study variables. Access Details: Time Frame: Up to five years after study completion Eligible Individuals: Access to the raw and analyzed data of this study will be strictly limited to the core research team, including the principal investigator, research collaborators, and the statistical analyst whose names are listed in the approved protocol and ethics committee approval. All team members will be required to sign a data confidentiality agreement prior to the initiation of the study. Data will be stored and analyzed in a coded format without any personally identifiable information. Access will be restricted to password-protected computers located in secure areas. Any transfer or sharing of data with individuals or organizations outside the research team will only be done with written approval from the Ethics Committee and in a de-identified form, in accordance with legal Request Process: Contact Elham Zandi Email: ellhamzandi.617@gmail.com | Phone: +98 901 183 7617 Conditions for Access: Signing a Data Use Agreement and ethics board approval When: Up to five years To whom: De-identified IPD, together with the data dictionary, study protocol, statistical analysis plan, and analysis code, will be available after study completion and primary analysis and for up to five years after publication of the primary results to qualified researchers. Access requires a formal request (including a secondary-analysis proposal), approval from an appropriate REC/IRB, and a Data Use Agreement (DUA); data will be provided in de-identified form via a secure institutional server and used for non-commercial scientific purposes (e.g., meta-analysis, validation, and related secondary analyses). Conditions: Available upon request for research or educational purposes. Where to obtain: Elham Zandi Masters Student of Islamic Azad University of Karaj Branch ellhamzandi.617@gmail.com 0901183761 How to obtain: Request Process: Contact Elham Zandi Email: ellhamzandi.617@gmail.com | Phone: +98 901 183 7617 Conditions for Access: Signing a Data Use Agreement and ethics board approval Comments:
public Sharareh Zeighami Mohammadi
Islamic Azad University, Karaj Branch, Imam Ali Complex, Moazen Blvd, Rajaee Shahr, Karaj, Alborz
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3418 2570 zeighamimohammadi@iau.ac.ir Islamic Azad University scientific Sharareh Zeighami Mohammadi
Islamic Azad University, Karaj Branch, Imam Ali Complex, Moazen Blvd, Rajaee Shahr, Karaj, Alborz
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3410 2570 zeighamimohammadi@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) being a student in a non-medical field at islamic azad university, karaj branch being enrolled in an undergraduate program at the time of study age between 18 and 25 years providing written informed consent to participate in the study Access to digital tools such as smartphones, laptops, or PCs to view the educational content (in the intervention group) ability to read, write, and understand persian 18 years 25 years Both Prior HPV vaccination Known HPV infection or related conditions (e.g., genital warts/precancerous cervical lesions) Any formal/informal HPV or HPV-vaccine education within the past 6 months Severe psychiatric/neurological disorders impairing learning or questionnaire completion (self-report ) Inability to use digital tools due to severe sensory/physical limitations. B97.7 Papillomavirus as the cause of diseases classified elsewhere Prevention Prevention Prevention Intervention Group 1: Digital Storytelling-Based Education; This group will participate in a two-week educational program consisting of four sessions (two sessions per week). Each session includes the presentation of a 5-minute educational video based on real-life stories and scientifically validated information about Human Papillomavirus (HPV) and its vaccination. The videos will be delivered via secure online platforms or privacy-adjusted messaging applications.After watching each video, a 20-minute live online session will be held, led by the researcher, for Q&A, clarification, and discussion.Equipment and software used include InShot for video editing, Audacity for voice recording and editing, and standard audio-visual recording tools. All educational content will be reviewed and approved by two nursing and midwifery faculty members prior to implementation. The total duration of the intervention for each participant will be two weeks. Intervention Group 2 (Active Control): Traditional EducationThis group will attend a single, in-person, 2-hour educational session. The training will include PowerPoint presentations, educational images, and verbal explanations covering HPV, its transmission, complications, and the importance of vaccination. At the end of the session, a 20-minute Q&A segment will be conducted face-to-face. Additionally, a printed educational pamphlet containing scientifically validated information will be provided to participants.Educational tools include projector, laptop, PowerPoint presentation, and printed pamphlets. The entire intervention for this group will be delivered in one single session. Control Group (No Intervention): Participants in this group will receive no training or intervention during the study period. Only after completing the post-test will they be provided with an educational pamphlet similar to the active control group, in order to increase their awareness. This measure is intended to adhere to ethical principles and ensure all participants have access to scientifically accurate information. Knowledge level about Human Papillomavirus (HPV). Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Knowledge and Attitude toward HPV questionnaire – Knowledge section (Pourkazemi et al., 2017), 36 items in three domains: general knowledge (13 items), cervical cancer risk factors (9 items), transmission routes and predisposing factors (14 items). Attitude toward HPV. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Knowledge and Attitude toward HPV questionnaire – Attitude section (Pourkazemi et al., 2017), 9 items, 3-point Likert scale (agree=3, neutral=2, disagree=1). Knowledge about HPV vaccine. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: HPV Vaccine Knowledge Questionnaire (Mojahed et al., 2023), 10 items assessing prevention effect, side effects, appropriate age, and administration conditions. Attitude toward HPV vaccination. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention. Method of measurement: Attitude toward HPV Vaccination Questionnaire (McRee et al., 2010; Dempsey et al., 2014), 17 items, five domains: Access barriers (5), Harms (3), Effectiveness (3), Risk denial (3), Uncertainty (3). Islamic Azad University Karaj branch Approved 2025-06-24 Research ethics committees of Islamic Azad University-Karaj branch Ethics Committee, Faculty of Medical Sciences, Islamic Azad University, Karaj Branch, Imam Ali Complex, Moazen Blvd, Rajaee Shahr, Karaj, Alborz Karaj Alborz Iran (Islamic Republic of)