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IRCT20230903059348N1 IRCT 2023-10-14 The university of Tarbiat Modares Development and validation of sexual health application Development and validation of a smartphone application to improve the sexual health of breast cancer survivors. 2024-02-20 anticipated 76 Complete https://irct.ir/trial/72427 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocked randomization method will be used to allocate the participants in the study groups, so that according to the groups under investigation (2 groups), AABB blocks of 4 will be formed, and then all possible combinations of them will be formed, will be listed and a code will be assigned for each of these combinations, then according to the sample volume (76) and the volume of blocks, which will be 4, 19 blocks will be allocated. N/A sextual health. Intervention 1: "Intervention group" :At first, in the intervention group, based on needs assessment, a sexual health application for people with breast cancer will be designed and implemented by the researcher.. By using the password, people are added to the application. In this research, the assessment of sexual health of people will be based on the determinants of the Woods conceptual model and the intervention based on the PLISSIT approach. Intervention strategies include four stages of questions and answers about sexual issues and sexual beliefs, education about sexual misconceptions, sexual and marital counseling, and referral to specialists including urology, infectious diseases, gynecology, and psychologists, depending on the needs of each person. The researcher will guide the participants to each of these strategies in a period of 4 months with weekly sessions (the interval between weeks will be determined based on the needs of the patient and individually) of 45 minutes and It will carry out three question and answer strategies, training and counseling, and at the end, if needed, it will refer the participants to one or more experts. The first intervention strategy includes question and answer sessions in the form of text, audio or, if the participants wish, video. Another strategy is education intervention, education is divided into two sub-sets, general education about sexual health that is done for all participants and referring the individual or couple to a specific topic that is based on the existing problem of education in that context is required and is provided to the participants in the form of a figure, text, slide or video. In another strategy, counseling intervention takes place. Counseling will be done mainly online, and if needed, the person will be referred to specialists. The last strategy is active referral to the relevant specialist. According to the patient's needs, active referrals are made by the researcher, and according to the needs of the individual, online communication or face-to-face referrals are made. At the end of each session, the modules selected by the therapist will be provided to each person according to their needs, and then the homework results report will be sent through another module in the form of a text message. Intervention 2: "Control group": Control group: At the end of the study, the control group will receive the booklet "Sexual health in breast cancer patients" and if the intervention is effective, the application will also be available to them. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period will start 6 months after the results are published. To whom: The data will be available to researchers working in universities and industry. Conditions: Any type of analysis or statistical use of data whose results help to improve the quality of life and health of the participants under study or have a positive scientific result in this field will be allowed. Where to obtain: Data will be sent through e-mail fatemehbagheri83@yahoo. Fatima Bagheri Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University, PO Box: 111-14115. Faculty of Midwifery and Reproductive Health. Data will be sent via e-mail moghaddamb@modares.ac.ir. Lida Moghadam Benaim Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University, PO Box: 111-14115. Faculty of Midwifery and Reproductive Health. How to obtain: After the request by the requester, his request will be immediately checked by the research team, after the confirmation of the research team to provide the results to the requester, verification will be done from the requester, if the verification is approved, the data will be provided within 6 weeks after the request. Comments:
public Fatemeh Bagheri
Jalal Al Ahmad St., Tarbiat Modares University, PO Box: 175-14115.
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 0000 fatemehbagheri83@yahoo.com Tarbiat Modares University scientific Lida Moghaddam-Banaem
Tehran, Jalal Al Ahmad, Nasr Bridge
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3857 moghaddamb@modares.ac.ir The University of Tarbiat Modares Iran (Islamic Republic of) Women in the age group of 18 to 60 years Married and currently living with a spouse Having a smart Android mobile phone Existence of sexual dysfunction based on the FSFI questionnaire and scoring less than 28 Diagnosed with non-invasive breast cancer within the last six years at most At least three months have passed since mastectomy or lumpectomy and receiving adjuvant treatment (such as radiation therapy, chemotherapy or hormone therapy) spoken and written proficiency in Persian language Internet access 18 years 60 years Female Existence of mental illnesses Simultaneous treatment of another type of cancer The presence of severe problems in marital relationships (for example, the presence of significant violence or abuse and conflict with the spouse - measured by screening questions such as how is your general relationship with your spouse?, Do you live in the same house?, Do you share a bedroom and bed ?) Simultaneous treatment to reduce sexual, emotional and psychological problems5. Existence of polygamy XXI Factors influencing health status and contact with health services Rehabilitation Rehabilitation "Intervention group" :At first, in the intervention group, based on needs assessment, a sexual health application for people with breast cancer will be designed and implemented by the researcher.. By using the password, people are added to the application. In this research, the assessment of sexual health of people will be based on the determinants of the Woods conceptual model and the intervention based on the PLISSIT approach. Intervention strategies include four stages of questions and answers about sexual issues and sexual beliefs, education about sexual misconceptions, sexual and marital counseling, and referral to specialists including urology, infectious diseases, gynecology, and psychologists, depending on the needs of each person. The researcher will guide the participants to each of these strategies in a period of 4 months with weekly sessions (the interval between weeks will be determined based on the needs of the patient and individually) of 45 minutes and It will carry out three question and answer strategies, training and counseling, and at the end, if needed, it will refer the participants to one or more experts. The first intervention strategy includes question and answer sessions in the form of text, audio or, if the participants wish, video. Another strategy is education intervention, education is divided into two sub-sets, general education about sexual health that is done for all participants and referring the individual or couple to a specific topic that is based on the existing problem of education in that context is required and is provided to the participants in the form of a figure, text, slide or video. In another strategy, counseling intervention takes place. Counseling will be done mainly online, and if needed, the person will be referred to specialists. The last strategy is active referral to the relevant specialist. According to the patient's needs, active referrals are made by the researcher, and according to the needs of the individual, online communication or face-to-face referrals are made. At the end of each session, the modules selected by the therapist will be provided to each person according to their needs, and then the homework results report will be sent through another module in the form of a text message. "Control group": Control group: At the end of the study, the control group will receive the booklet "Sexual health in breast cancer patients" and if the intervention is effective, the application will also be available to them. The score of sexual function in Female Sexual Function Index(FSFI). Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the intervention. Method of measurement: Female Sexual Function Index(FSFI) questionnaire. Body image concern score in the Body Image Concern Index (BICI) questionnaire. Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the. Method of measurement: Body Image Concern Index (BICI) questionnaire. Marital satisfaction score from Enrich Marital Satisfaction Questionnaire. Timepoint: At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the. Method of measurement: Enrich Marital Satisfaction Questionnaire. App usability evaluation. Timepoint: End of intervention. Method of measurement: Modified Persian version of the questionnaire of usefulness, satisfaction and ease of use (USE). The university of Tarbiat Modares Approved 2022-10-03 Research ethics committees of tarbiat modares university Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University تهزان Tehran Iran (Islamic Republic of)