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IRCT20160619028528N6 IRCT 2022-01-29 Mazandaran University of Medical Sciences The effect of mobile application-based educational intervention on promoting the knowledge of vulnerable women to human papillomavirus (HPV): a randomized controlled clinical trial The effect of mobile application-based educational intervention on promoting the knowledge of vulnerable women to human papillomavirus (HPV) 2022-02-04 anticipated 40 Complete https://irct.ir/trial/61291 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocked random allocation method will be used for random assignment of samples to two intervention groups and control group (routine care). For this purpose, quadruple blocks will be considered. The six blocks may be TCTTCC, CTTC, CTCT, CCTT, TCTC, TCCT, with T being for the intervention group and C for the control group. The randbetween function in Excel will be used to randomly select blocks. Production numbers will be between 1 and 6 and will be selected based on the production number of the desired block and all 4 samples will be assigned to the intervention and control group, Blinding description: Due to the nature of the intervention, it will not be possible to keep participants blind during the intervention process. Blinding will take place at the level of the responsible researcher. In this way, the researcher will not be aware of how the individuals are randomized to the intervention and control groups. Also, in order to control the bias at the level of the evaluator (detection bias), the blinding process will be performed on the people who are responsible for collecting information and analyzing the data. 3 Condition 1: human papillomavirus (HPV). Condition 2: Anogenital warts. Intervention 1: This intervention is based on improving the knowledge of human papillomavirus as a first outcome and promoting the attitude and practice of vulnerable women as a secondary outcome through the mobile application. The content of the application has been prepared by a master's student in midwifery counseling. The research team includes a reproductive health specialist, a reproductive epidemiologist, a sexual health specialist, a psychiatrist, and a midwifery counseling student. After randomly assigning, the intervention group receives the application installation link, and after installing the application on the smartphone, users self-learning for a month. After a month, the application is automatically deactivated and users' access to the app content is cut off. Educational objectives are classified into three areas: affective, psychomotor, and cognitive. In the field of cognition, users are expected to learn about the nature of the HPV virus, its abbreviation, how it is transmitted, its prevalence in vulnerable women, preventive behaviors, the HPV vaccine, and high-risk behaviors after one month. In the field of ​affective, participants are expected to become familiar with common but incorrect beliefs and attitudes and replace them with the right attitudes.In the field of psychomotor, we expect vulnerable women to express behavioral goals that they have learned cognitively about preventive behaviors as behavioral intentions or to seek prevention and treatment if they have a midwife or specialist. The training framework will be implemented through this software in the method of repeated learning. In this context, users will receive a single content using a variety of methods, in simple language, understandable to the target group, and attractive to gradually reinforce the behavioral intent in them. The educational content before loading on the application will be evaluated by the panel of experts, scientifically, literary, and the opinion of the same audience group. Post-loading evaluation: Educational content after loading on the application by two groups of hardware technicians and the matched audience group is evaluated. The effect of the application on improving the outcome (knowledge about human papillomavirus) will be calculated through indicators such as the Effect Size index. Intervention 2: Control group: The women in the control group will receive routine care from the Vulnerable Women's Center. This care is provided in the context of health-focused visits, gynecological examinations, and counseling on high-risk behaviors related to AIDS. After completing the last questionnaire (5 weeks after the last follow-up), in order to enjoy the benefits of the study, an application link will be sent to them and we will answer their questions. 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 There is no further information
public Mobina Moghassemi
Kosar dormitory, Mohtasham Ave, No 15 Piroozi street, Sari, Mazandaran.
Sari Iran (Islamic Republic of) 4818899795 +98 11 3311 3641 m.moghssmi@gmail.com Mazandaran University of Medical Sciences scientific Dr. Zeinab Hamzehgardeshi
Nasibeh Nursing and Midwifery Faculty, Amir Mazandarani Street
Sari Iran (Islamic Republic of) 48431-63181 009833367342 z.hamzehgardeshi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Fluency in Persian Be part of a vulnerable group of women Literacy for reading and writing Has a smartphone and the ability to use it no limit no limit Female women with acute psychiatric disorders such as schizophrenia (Inserted in the health record) B97.7 A63.0 Papillomavirus as the cause of diseases classified elsewhere Anogenital (venereal) warts Prevention Prevention This intervention is based on improving the knowledge of human papillomavirus as a first outcome and promoting the attitude and practice of vulnerable women as a secondary outcome through the mobile application. The content of the application has been prepared by a master's student in midwifery counseling. The research team includes a reproductive health specialist, a reproductive epidemiologist, a sexual health specialist, a psychiatrist, and a midwifery counseling student. After randomly assigning, the intervention group receives the application installation link, and after installing the application on the smartphone, users self-learning for a month. After a month, the application is automatically deactivated and users' access to the app content is cut off. Educational objectives are classified into three areas: affective, psychomotor, and cognitive. In the field of cognition, users are expected to learn about the nature of the HPV virus, its abbreviation, how it is transmitted, its prevalence in vulnerable women, preventive behaviors, the HPV vaccine, and high-risk behaviors after one month. In the field of ​affective, participants are expected to become familiar with common but incorrect beliefs and attitudes and replace them with the right attitudes.In the field of psychomotor, we expect vulnerable women to express behavioral goals that they have learned cognitively about preventive behaviors as behavioral intentions or to seek prevention and treatment if they have a midwife or specialist. The training framework will be implemented through this software in the method of repeated learning. In this context, users will receive a single content using a variety of methods, in simple language, understandable to the target group, and attractive to gradually reinforce the behavioral intent in them. The educational content before loading on the application will be evaluated by the panel of experts, scientifically, literary, and the opinion of the same audience group. Post-loading evaluation: Educational content after loading on the application by two groups of hardware technicians and the matched audience group is evaluated. The effect of the application on improving the outcome (knowledge about human papillomavirus) will be calculated through indicators such as the Effect Size index. Control group: The women in the control group will receive routine care from the Vulnerable Women's Center. This care is provided in the context of health-focused visits, gynecological examinations, and counseling on high-risk behaviors related to AIDS. After completing the last questionnaire (5 weeks after the last follow-up), in order to enjoy the benefits of the study, an application link will be sent to them and we will answer their questions. Knowledge about human papillomavirus. Timepoint: At the time of enrollment - immediately after the intervention - five weeks after the intervention. Method of measurement: Questionnaire of knowledge, attitude, practice about human papillomavirus. Attitudes about human papillomavirus. Timepoint: At the time of enrollment - immediately after the intervention - five weeks after the intervention. Method of measurement: Questionnaire of knowledge, attitude, practice about human papillomavirus. Practice about human papillomavirus. Timepoint: At the time of enrollment - immediately after the intervention - five weeks after the intervention. Method of measurement: Questionnaire of knowledge, attitude, practice about human papillomavirus. Mazandaran University of Medical Sciences Approved 2022-01-12 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for research, Mazandaran University of Medical Sciences ,Moalem Square, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)