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IRCT20260908070965N1 IRCT 2026-11-08 Yazd University of Medical Sciences The Effect of Information-Motivation-Behavioral Skills Counseling on Sexual Relationship Anxiety, Awareness, and Willingness to Receive the Human Papillomavirus Vaccine Examining the Effectiveness of the Information-Motivation-Behavioral Skills Counseling Model on Sexual Relationship Anxiety, Awareness Regarding the Human Papillomavirus Vaccine, and the Intention to Receive and Actual Receipt of the Vaccine Among Women with Cervical Dysplasia 2026-11-22 anticipated 86 Pending https://irct.ir/trial/93286 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were assigned to study groups using a permuted block randomization method with a fixed block size of 4. The random allocation sequence was generated using the Random Allocation Software. This method was employed to maintain a balanced number of participants across the study groups. To ensure allocation concealment, the allocation sequences were placed in opaque, sealed, and numbered envelopes. These envelopes were opened sequentially following the enrollment and registration of each participant to prevent the researcher from having prior knowledge of the participants' group assignments. N/A Human papillomavirus. Intervention 1: Intervention Group: Participants in the intervention group receive counseling based on the Information-Motivation-Behavioral Skills (IMB) model, delivered via the Skyroom platform across eight weekly, 90-minute sessions. The counseling is conducted by a researcher pursuing a master's degree in Midwifery Counseling—who is certified to administer IMB-based counseling—under the supervision of faculty advisors. The intervention consists of eight virtual group counseling sessions, each lasting 90 minutes, with content structured around the IMB counseling approach.The program consists of eight sessions covering the following topics: raising awareness about HPV; correcting misconceptions and boosting learning motivation; identifying signs of sexual anxiety; shifting attitudes toward healthy sexual relations; training couples in communication and anxiety-management behavioral skills; encouraging HPV vaccination; and reviewing and consolidating acquired skills. These sessions are conducted virtually once a week via the Skyroom platform, utilizing PowerPoint presentations and Q&A segments. Notably, a summary of key points from each session is recorded and made available to the participants for repeated viewing. To facilitate this, the researcher will collect participants' mobile numbers after obtaining informed consent and establish a messaging group managed by the researcher.The researcher will handle all necessary communications with study participants regarding coordination—such as participation in the group channel, delivery of session content at scheduled times, reminders about homework assignments, and handling private inquiries following group counseling sessions. It should be noted that summaries of key points from each session will be recorded and made available to the women for repeated viewing. To facilitate this, the researcher will collect participants' mobile numbers after obtaining informed consent and will set up and manage a messaging group. Intervention 2: Control group: In the control group, routine care such as education on strengthening the immune system, stress reduction, and maintaining personal hygiene will also be provided at the Baghaeipour Clinic. Yes - There is a plan to make this available What will be shared: All individual data of study participants can be shared after the individuals have been de-identified. When: After the results are published To whom: The data will be available to researchers affiliated with academic and scientific institutions, and individuals working in the industry may also apply to obtain them Conditions: Should other researchers request access to the data for the purpose of conducting secondary analysis, such access will be granted only upon submission of a written request outlining the objectives and the proposed analytical methodology and subject to the approval of the principal investigator. The data will be provided to applicants solely in a de-identified format, with all participant-identifying information removed. Applicants are required to adhere to principles of confidentiality, ensure data security, and utilize the information exclusively for the approved objectives. Where applicable, obtaining approval from an ethics committee and securing any other necessary authorizations is mandatory prior to accessing the data Where to obtain: farajkhoda.tahmineh31255@gmail.com Dr. Tahmineh Farajkhoda How to obtain: One week after receiving the applicant's email Comments:
public Tahmineh Farajkhoda
Bu Ali Str
yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1751 farajkhoda.tahmineh31255@gmail.com Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
Bu Ali str
yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1751 farajkhoda.tahmineh31255@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Reproductive age Moderate to severe anxiety scores related to sexual activity, based on the Davis questionnaire Diagnosis of cervical dysplasia based on confirmation by the attending physician and the clinic's records. Having the desire and informed consent to participate in the research Ability to read, write, and speak Persian Women who live with their husbands and are their husbands' only wives Owning an Android or iOS smartphone 15 years 45 years Female Need for referral to a psychiatrist and pharmacological treatment due to psychiatric disorders History of HPV vaccination Concurrent participation in similar studies Has not experienced stressful events such as migration, the death of a loved one, divorce, or financial difficulties within the past six months. Use of tobacco, illicit drugs, and alcohol, according to the patient and their medical record Presence of other conditions affecting sexual function, such as vaginismus, vestibulodynia, vulvar skin disorders, painful bladder syndrome or interstitial cystitis, and pregnancy Developing gynecological cancers, such as cancers of the cervix, uterus, ovary, etc Pregnancy N87 Dysplasia of cervix uteri Behavior Prevention Intervention Group: Participants in the intervention group receive counseling based on the Information-Motivation-Behavioral Skills (IMB) model, delivered via the Skyroom platform across eight weekly, 90-minute sessions. The counseling is conducted by a researcher pursuing a master's degree in Midwifery Counseling—who is certified to administer IMB-based counseling—under the supervision of faculty advisors. The intervention consists of eight virtual group counseling sessions, each lasting 90 minutes, with content structured around the IMB counseling approach.The program consists of eight sessions covering the following topics: raising awareness about HPV; correcting misconceptions and boosting learning motivation; identifying signs of sexual anxiety; shifting attitudes toward healthy sexual relations; training couples in communication and anxiety-management behavioral skills; encouraging HPV vaccination; and reviewing and consolidating acquired skills. These sessions are conducted virtually once a week via the Skyroom platform, utilizing PowerPoint presentations and Q&A segments. Notably, a summary of key points from each session is recorded and made available to the participants for repeated viewing. To facilitate this, the researcher will collect participants' mobile numbers after obtaining informed consent and establish a messaging group managed by the researcher.The researcher will handle all necessary communications with study participants regarding coordination—such as participation in the group channel, delivery of session content at scheduled times, reminders about homework assignments, and handling private inquiries following group counseling sessions. It should be noted that summaries of key points from each session will be recorded and made available to the women for repeated viewing. To facilitate this, the researcher will collect participants' mobile numbers after obtaining informed consent and will set up and manage a messaging group. Control group: In the control group, routine care such as education on strengthening the immune system, stress reduction, and maintaining personal hygiene will also be provided at the Baghaeipour Clinic. Sexual anxiety. Timepoint: The primary outcome variable, sexual anxiety, is measured at baseline (prior to the start of the intervention), at the conclusion of the intervention (week 8), and at the follow-up assessment (week 12). Method of measurement: Davis Sexual Relationship Anxiety Assessment Questionnaire. The first secondary outcome variable is awareness regarding the human papillomavirus vaccine among women with cervical dysplasia. Timepoint: The secondary outcome variable awareness regarding the human papillomavirus vaccine among women with cervical dysplasia is measured at baseline (prior to the start of the intervention), at the conclusion of the intervention (week 8), and at the end of the study (week 12). Method of measurement: Human Papillomavirus Vaccine Awareness Questionnaire. Second secondary outcome variable intention to receive the human papillomavirus vaccine among women with cervical dysplasia. Timepoint: The secondary outcome variable intention to receive the human papillomavirus vaccine is measured in women with cervical dysplasia at baseline (prior to the intervention), at the conclusion of the intervention (week 8), and at the end of the study (week 12). Method of measurement: It is examined using two questions in the questionnaire. Third secondary outcome variable administration of the human papillomavirus vaccine in women with cervical dysplasia. Timepoint: The secondary outcome variable administration of the human papillomavirus vaccine is measured in women with cervical dysplasia at baseline (prior to the intervention), upon completion of the intervention at week 8, and at the end-of-study follow-up at week 12. Method of measurement: It is examined using two questions in the questionnaire. Yazd University of Medical Sciences Approved 2026-07-13 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd No. 48,Azadshahr, between the 2nd and 3rd Roundabouts, Yas Alley yazd Yazd Iran (Islamic Republic of)