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IRCT20220302054166N1 IRCT 2022-05-11 Shahroud University of Medical Sciences The effect of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health The effect of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health: a randomized clinical trial study 2022-05-28 anticipated 108 Complete https://irct.ir/trial/63313 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the randomization method will be a randomized block design with a block size of 4. The block randomization method is designed to randomize participants into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. in this clinical trial with control and treatment groups, a randomized block procedure would be as follows: (1) block size of 4 will be chosen, (2) possible balanced combinations with 2 T (intervention) and 2 C (control) subjects will be calculated as 6 (CCTT, CTCT, CTTC, TCCT, TCTC, TTCC) and (3) blocks will be randomly chosen to determine the assignment of all participants. N/A genital self-image in women. Intervention 1: The intervention group will spend 8 weeks, one session per week (8 sessions in total) and each session for 90 minutes in the Skyroom space, the link of which has been sent to them via WhatsApp, and will receive the content of the intervention provided by the researcher. On the other hand, the content provided will be placed in the WhatsApp group space so that participants can refer to it again and use it if they wish. In addition, if you have any questions, mention them in the group so that the researcher can review and answer them. Intervention 2: Control group: The control group will receive the mobile application but they did not access the intervention content until the end of the research. Then, based on the ethics of the research and their willingness can use the content of Intervention. Standard questionnaires will be completed before, immediately after 6 sessions of intervention, and 2 months after the intervention in the control group. 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 due to ethical issues and confidential data protection
public Maryam Farjamfar
7tir street
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 5054 viraa.academy@yahoo.com Shahroud University of Medical Sciences scientific Maryam Farjamfar
7tir street
Shahroud Iran (Islamic Republic of) 3614773947 +98 23 3239 5054 viraa.academy@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Having Iranian nationality reading and writing literacy Being married Sexuality active not being pregnant not being Menopause not being in the first six months after childbirth Having a mobile phone with Android system and internet access Satisfaction and voluntary participation Healthy women in terms of genital anatomy based on self-report Absence of major psychiatric disorders based on self-report (such as depression, anxiety, obsession) No history of genital surgeries such as hysterectomy, oophorectomy No cancer in the genital area (like vagina cancer, cervix cancer) 15 years 49 years Female Unwillingness of the women to continue participating in the study N/A N/A The intervention group will spend 8 weeks, one session per week (8 sessions in total) and each session for 90 minutes in the Skyroom space, the link of which has been sent to them via WhatsApp, and will receive the content of the intervention provided by the researcher. On the other hand, the content provided will be placed in the WhatsApp group space so that participants can refer to it again and use it if they wish. In addition, if you have any questions, mention them in the group so that the researcher can review and answer them. Control group: The control group will receive the mobile application but they did not access the intervention content until the end of the research. Then, based on the ethics of the research and their willingness can use the content of Intervention. Standard questionnaires will be completed before, immediately after 6 sessions of intervention, and 2 months after the intervention in the control group. Genital self-image. Timepoint: Before the intervention, immediately and 2 months after the intervention. Method of measurement: d Female Genital Self-Image Scale(FGSIS). Reproductive health (Intention of Reproductive Health Promoting Behaviors and sexual health (such as sexual function, sexual distress, sexual self-esteem, and sexual satisfaction). Timepoint: Before the intervention, immediately and 2 months after the intervention. Method of measurement: The intention of Reproductive Health Promoting Behaviors, (Female Sexual Distress Scale-Revised(FSDS-R)), (Female Sexual dysfunction index(FSFI-6)), Sexual self-esteem, sexual satisfaction. Shahroud University of Medical Sciences Approved 2020-02-03 Ethics committee of Shahroud University of Medical Sciences Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran Shahroud Semnan Iran (Islamic Republic of)