]>
IRCT20260704070060N1 IRCT 2026-08-10 Mazandaran University of Medical Sciences Effectiveness of solution focused brief therapy on students’ perceived self-efficacy regarding Human Papillomavirus vaccination Effectiveness of solution focused brief therapy on students’ perceived self-efficacy regarding Human Papillomavirus vaccination: A Randomized Controlled Trial 2026-08-08 anticipated 160 Recruiting https://irct.ir/trial/91395 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants who meet the eligibility criteria will be randomly allocated to the intervention or control group using block randomization with a 1:1 allocation ratio. The unit of randomization is the individual participant and no stratified randomization will be applied. The random allocation sequence will be generated before participant recruitment by a statistician who is not involved in participant recruitment or outcome assessment, using Microsoft Excel and the RANDBETWEEN function. Participants will be allocated in 40 blocks of four (total sample size = 160). Six possible block arrangements (TTCC, TCTC, TCCT, CCTT, CTCT, and CTTC) will be used, where T represents the intervention group and C represents the control group. Using the RANDBETWEEN function in Excel, a random number between 1 and 6 will be generated 40 times, and each generated number will correspond to one of the six block arrangements. Accordingly, participants will be assigned to the intervention or control group in a balanced manner within each block. To minimize selection bias, allocation concealment will be implemented. After generation of the random allocation sequence, the assignment for each participant will be placed in sequentially numbered, opaque, light-proof, sealed envelopes prepared by an individual who is not involved in participant recruitment. After confirming eligibility and obtaining written informed consent, the envelope corresponding to each participant will be opened sequentially to reveal the assigned group. Therefore, the researcher responsible for participant recruitment will remain unaware of the allocation until the moment of assignment. N/A This study aims to evaluate the effectiveness of Solution-Focused Brief Therapy (SFBT) on students' perceived self-efficacy regarding human papillomavirus (HPV) vaccination to promote HPV vaccination and prevent HPV infection.. Intervention 1: Intervention group: Participants in the intervention group will receive four weekly group counseling sessions based on Solution-Focused Brief Therapy (SFBT), each lasting 45–60 minutes, delivered by the principal investigator certified in SFBT at the amphitheater of the School of Health and Pharmacy. Participants will be divided into four groups of 20. The sessions will incorporate standard SFBT techniques, including the miracle question, exception finding, scaling questions, and coping questions, with the aim of enhancing perceived self-efficacy regarding HPV vaccination, reducing vaccination hesitancy, and strengthening motivation for informed decision-making. Intervention 2: Control group: At the end of the intervention, the control group will receive one session of routine education on the importance of Human Papillomavirus (HPV) vaccination, delivered virtually via Google Meet. 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 _
public Diana Azizi
No. 42, Moallem 28 Alley, Moallem Street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3311 1959 dianaazizi1991@gmail.com Mazandaran University of Medical Sciences scientific Asana Esmaeeli Basharik
No. 42, Moallem 28 Alley, Moallem Street
Sari Iran (Islamic Republic of) 4815733971 +98 11 3311 1959 asanaesmaeeli@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study and provision of written informed consent Female students Ability and willingness to participate in face-to-face group counseling sessions Current enrollment in one of the faculties of Mazandaran University of Medical Sciences (Sari Campus) during the 2025–2026 academic year Adequate proficiency in the Persian language to understand the study questionnaires content and participate in the counseling sessions No previous receipt of any dose of the Human Papillomavirus (HPV) vaccine, based on self-report Low to moderate perceived score self-efficacy regarding HPV vaccination, indicating eligibility for the intervention No self-reported history of infection with any HPV genotype or HPV-related malignancies (e.g., cervical cancer) No current use of psychotropic medications, based on self-report No current substance use disorder, based on self-report no limit no limit Female Failure to complete more than 20% of the items in any of the study questionnaires Receipt of any dose of the HPV vaccine at any time during the study period (from screening to the end of follow-up) Participation in any specialized educational or counseling program related to HPV vaccination within the previous six months Presence of severe psychiatric disorders or other mental illnesses diagnosed by a psychiatrist, based on self-report, that may interfere with effective participation in the counseling sessions Pregnancy or intention to become pregnant during the study period Presence of any acute illness or medical condition constituting a contraindication to HPV vaccination (e.g., a history of severe allergic reactions), as confirmed in consultation with an infectious disease specialist unwillingness to continue participation at any stage of the study Z11.51 Encounter for screening for human papillomavirus (HPV) Behavior Behavior Intervention group: Participants in the intervention group will receive four weekly group counseling sessions based on Solution-Focused Brief Therapy (SFBT), each lasting 45–60 minutes, delivered by the principal investigator certified in SFBT at the amphitheater of the School of Health and Pharmacy. Participants will be divided into four groups of 20. The sessions will incorporate standard SFBT techniques, including the miracle question, exception finding, scaling questions, and coping questions, with the aim of enhancing perceived self-efficacy regarding HPV vaccination, reducing vaccination hesitancy, and strengthening motivation for informed decision-making. Control group: At the end of the intervention, the control group will receive one session of routine education on the importance of Human Papillomavirus (HPV) vaccination, delivered virtually via Google Meet. Perceived self-efficacy regarding Human Papillomavirus (HPV) vaccination. Timepoint: At baseline, immediately after completion of the counseling intervention, and one month after the intervention. Method of measurement: The primary outcome is perceived self-efficacy regarding Human Papillomavirus (HPV) vaccination, which will be measured using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire at three time points: baseline (before the intervention), immediately after completion of the counseling sessions, and one month after the intervention. Perceived susceptibility to Human Papillomavirus. Timepoint: will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention. Method of measurement: using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire. Perceived severity of the consequences of Human Papillomavirus. Timepoint: will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention. Method of measurement: using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire. Perceived benefits of Human Papillomavirus vaccination. Timepoint: will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention. Method of measurement: using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire. Perceived barriers to Human Papillomavirus vaccination. Timepoint: will be measured at three time points: before the intervention (baseline), immediately after completion of the counseling sessions, and one month after the intervention. Method of measurement: using the Health Belief Model Constructs Related to HPV Vaccination Questionnaire. Satisfaction with the intervention. Timepoint: will be assessed immediately after the final intervention session and at the one-month follow-up. Method of measurement: using the Visual Analog Scale (VAS) for intervention satisfaction. Mazandaran University of Medical Sciences Approved 2026-08-05 Ethics Committee of Mazandaran University of Medical Sciences Moallem Square, Deputy of research and technology, Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)