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IRCT20230710058738N1 IRCT 2023-08-22 Yazd University of Medical Sciences Sexual health empowerment model versus DEEP model (Natural Differences, Emotional Sensitivities, External Stressors, Patterns of Communication) on sexual function and attitude and performance of condom use in Papillomavirus infected women The effectiveness comparison of sexual health empowerment model via DEEP model (Natural Differences, Emotional Sensitivities, External Stressors, Patterns of Communication) on sexual function and attitude and performance of condom use in papillomavirus infected women 2023-10-02 anticipated 68 Complete https://irct.ir/trial/71284 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible women, referring to Baqaeipour clinic in Yazd, are recruited according to the criteria of participating in the study. Convenience sampling is used. The ones with size 4 are obtained using the software www.random.org/sequences. Each woman is given a number between 1to 68. The women will be allocated in two groups DEEP model or Sexual health empowerment model (34 women in each group). Allocation concealment is used, so no women and researcher don't know each woman will allocate to each group. N/A Human Papilloma Virus. Intervention 1: The first intervention group: The first group will receive the DEEP model in the form of 8 online and consecutive sessions, once a week for 90 minutes, by the second researcher, a senior midwife counseling student who has completed the sexual disorders course and obtained the necessary certificate, under the supervision of the first researcher, the supervisor (reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (reproductive health specialist) will be held in the sky room. The content of the sessions will be in the format of educational videos, PowerPoint presentations, and questions and answers. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed, and the assignments related to the previous session will be reviewed by the first and second researcher to measure their improvement in each session. Women are asked to participate in counseling discussions and raise their questions. The second researcher will ask questions about the topics of the meeting for the participation of more people in the meeting. To learn more, the relevant educational video will also be presented to them. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the women are asked to do their homework until the next meeting. The content of the sessions of the DEEP model includes the description of the Deep model and the conceptualization of each word, pair evaluation, teaching strategies for acceptance, empathic attachment and creating empathy, controlling external factors, creating tolerance, creating change, and more preparation. Intervention 2: The second intervention group: the second group (control group) will receive the Sexual Health Empowerment model in the form of 8 online and consecutive sessions, once a week for 90 minutes, by the second researcher, a senior midwife counseling student who has completed the sexual disorders course and obtained the necessary certificate, under the supervision of the first researcher, the supervisor (reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (reproductive health specialist) will be held in the sky room. The content of the sessions will be in the format of educational videos, PowerPoint presentations, and questions and answers. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed, and the assignments related to the previous session will be reviewed by the first and second researcher to measure their improvement in each session. Women are asked to participate in counseling discussions and raise their questions. The second researcher will ask questions about the topics of the meeting for the participation of more people in the meeting. To learn more, the relevant educational video will also be presented to them. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the women are asked to do their homework until the next meeting.The content of the Sexual Health Empowerment model sessions includes getting to know this concept and its goals, recognizing and adapting to physiological and sexual differences in couples, correcting false beliefs and changing attitudes, explaining sexual concerns in these couples, learning skills to communicate effectively and negotiate with each other, to resolve conflicts and reduce risky behaviors, description of marital intimacy and its dimensions. Yes - There is a plan to make this available What will be shared: All individual data of study participants can be shared after de-identification. When: After publishing the results To whom: The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them. Conditions: Scientific application Where to obtain: farajkhoda_t@yahoo.com How to obtain: One week after receiving the applicant's email Comments:
public Tahmineh Farajkhoda
Bu Ali St
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۴۴۳ +98 35 3824 1751 farajkhoda_t@yahoo.com Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
Bu Ali St
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۴۴۳ +98 35 3824 1751 farajkhoda_t@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Having a medical record of being infected with papillomavirus (infection with low-risk or high-risk types of the virus and type 1 and 2 dysplasia) at Baghaeipour Clinic in Yazd, diagnosed by the physician Women in reproductive age (15 to 49 years) Being married Having sufficient sexual intercourse with the spouse in the past 4 weeks Willingness to participate in the study Owning an Android or iOS smartphone Being able to use online counseling via a smartphone Literacy in reading and writing Proficiency in speaking Persian Sexual dysfunction 15 years 49 years Female Pregnancy Condom use Diagnosis of psychological disorders in the past year according to women's statements Participation in similar studies Occurrence of stressful events during participation in the study (such as the death of family members or divorce) Addiction to drugs and alcohol Patients with hearing problems B97.7 Papillomavirus as the cause of diseases classified elsewhere Behavior Behavior The first intervention group: The first group will receive the DEEP model in the form of 8 online and consecutive sessions, once a week for 90 minutes, by the second researcher, a senior midwife counseling student who has completed the sexual disorders course and obtained the necessary certificate, under the supervision of the first researcher, the supervisor (reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (reproductive health specialist) will be held in the sky room. The content of the sessions will be in the format of educational videos, PowerPoint presentations, and questions and answers. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed, and the assignments related to the previous session will be reviewed by the first and second researcher to measure their improvement in each session. Women are asked to participate in counseling discussions and raise their questions. The second researcher will ask questions about the topics of the meeting for the participation of more people in the meeting. To learn more, the relevant educational video will also be presented to them. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the women are asked to do their homework until the next meeting. The content of the sessions of the DEEP model includes the description of the Deep model and the conceptualization of each word, pair evaluation, teaching strategies for acceptance, empathic attachment and creating empathy, controlling external factors, creating tolerance, creating change, and more preparation. The second intervention group: the second group (control group) will receive the Sexual Health Empowerment model in the form of 8 online and consecutive sessions, once a week for 90 minutes, by the second researcher, a senior midwife counseling student who has completed the sexual disorders course and obtained the necessary certificate, under the supervision of the first researcher, the supervisor (reproductive health specialist and clinical psychologist) and the third researcher, the consultant professor (reproductive health specialist) will be held in the sky room. The content of the sessions will be in the format of educational videos, PowerPoint presentations, and questions and answers. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed, and the assignments related to the previous session will be reviewed by the first and second researcher to measure their improvement in each session. Women are asked to participate in counseling discussions and raise their questions. The second researcher will ask questions about the topics of the meeting for the participation of more people in the meeting. To learn more, the relevant educational video will also be presented to them. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the women are asked to do their homework until the next meeting.The content of the Sexual Health Empowerment model sessions includes getting to know this concept and its goals, recognizing and adapting to physiological and sexual differences in couples, correcting false beliefs and changing attitudes, explaining sexual concerns in these couples, learning skills to communicate effectively and negotiate with each other, to resolve conflicts and reduce risky behaviors, description of marital intimacy and its dimensions. Sexual function (primary outcome variable). Timepoint: Baseline, completion of the intervention in the eighth week and follow-up at the end of the study in the twelfth week. Method of measurement: Rosen et al Sexual Functioning Questionnaire (1997). Attitude toward condom use (Secondary outcome variable). Timepoint: Baseline, completion of the intervention in the eighth week and follow-up at the end of the study in the twelfth week. Method of measurement: Attitude of Condom Use Questionnaire. The frequency of condom use (Secondary outcome variable). Timepoint: Baseline, completion of the intervention in the eighth week and follow-up at the end of the study in the twelfth week. Method of measurement: Performance of Condom Use Questionnaire. Yazd University of Medical Sciences Approved 2023-07-12 Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)