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IRCT20230808059085N1 IRCT 2023-09-11 Shahid Beheshti University of Medical Sciences The Comparison between the Effect of PLISSIT and Sexual Health Model on the Sexual Function and Sexual quality of life in menopause The Comparison between the Effectiveness of PLISSIT and Sexual Health Model on the Sexual Function and Sexual quality of life in menopause: A Randomized Clinical Trial 2023-09-17 anticipated 105 Complete https://irct.ir/trial/72491 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this research, randomization into three PLISSIT intervention groups (35 people), sexual health model group (35 people) and control group (35 people) will be done by simple randomization method.Random numbers were used to randomize and assign individuals to groups; randomization using Excel software is as follows: First, in a column, groups are entered as A, B, C, and below, because the number of samples in each group is set to 35 (including the sample fall), so 35, B, A, C must be as follows. And they come in regularly. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, random numbers generated from small to large or vice versa are arranged, which causes the order of the groups, C, A, B, to change. Using the new order, people are assigned to different groups, Blinding description: This study is a double-blind randomized clinical trial study.The participant and the data analyst are not aware of the grouping.The participants do not know the group they are in.The data analyst also knows the groups as A, B, and C and is unaware of the type of intervention of each group. N/A Sexual issues. Intervention 1: Intervention group: PLISSIT. Counseling will be done in three face-to-face and individual sessions and the duration of the sessions will be 60-90 minutes.The first stage of counseling involves getting to know the client and permiting her to talk about her sexual problems.In the next stage, limited information related to sexual anatomy, sexual physiology, and the sexual response cycle of Mstro-Johnson will be provided to the participants.The next stage includes providing special and specific information related to all kinds of sexual dysfunctions in women, and their sexual problems will be evaluated in a more specific and detailed manner.In the last stage, patients are referred to a sexologist for more specific treatment if they do not respond to the counseling steps and have complex sexual problems. Intervention 2: Intervention group: Sexual health model. Counseling will be in three face-to-face and individual sessions, and the duration of the sessions will be 60-90 minutes.The content of the sessions will cover ten aspects of the sexual health model, taking into account the Iranian culture,In the first session, about sexual discourse, sexual anatomy and challenges facing sexual health, in the second session, in relation to culture and tradition and sexual affairs, health care and safer sex, and positive sexuality, and in the third session, in relation to body image, fantasy and intimacy and spirituality will be discussed. Intervention 3: Control group: The control group will also receive routine menopause counseling. 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 zahrazamiriaraste
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 zahrazamiriaraste1997@yahoo.com Shahid Beheshti University of Medical Sciences scientific Masoumeh Simbar
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 msimbar@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) being married, Being literate in reading and writing, Being sexually active in the last month, Age range between 40_64, Menopause has occurred naturally, At least one year has passed since their menopause, Absence or history of known mental and physical illness that has a negative impact on sexual relations, Not taking drugs to reduce sexual desire, Do not use addictive substances and alcohol, No history of hysterectomy, Not having an adverse event within 3 months before the start of the intervention, Not having extramarital relations of each couple, Not participating in sex education classes or receiving sex counseling services 40 years 64 years Female Failure to participate in more than one intervention session, Marital discord, death or divorce during intervention, Performing surgery during intervention Prevention Prevention N/A Intervention group: PLISSIT. Counseling will be done in three face-to-face and individual sessions and the duration of the sessions will be 60-90 minutes.The first stage of counseling involves getting to know the client and permiting her to talk about her sexual problems.In the next stage, limited information related to sexual anatomy, sexual physiology, and the sexual response cycle of Mstro-Johnson will be provided to the participants.The next stage includes providing special and specific information related to all kinds of sexual dysfunctions in women, and their sexual problems will be evaluated in a more specific and detailed manner.In the last stage, patients are referred to a sexologist for more specific treatment if they do not respond to the counseling steps and have complex sexual problems. Intervention group: Sexual health model. Counseling will be in three face-to-face and individual sessions, and the duration of the sessions will be 60-90 minutes.The content of the sessions will cover ten aspects of the sexual health model, taking into account the Iranian culture,In the first session, about sexual discourse, sexual anatomy and challenges facing sexual health, in the second session, in relation to culture and tradition and sexual affairs, health care and safer sex, and positive sexuality, and in the third session, in relation to body image, fantasy and intimacy and spirituality will be discussed. Control group: The control group will also receive routine menopause counseling Female sexual function. Timepoint: Before, 4 and 6 weeks after the intervention. Method of measurement: Female Sexual Function questionnaire. Sexual Quality Of Life. Timepoint: Before, 4 and 6 weeks after the intervention. Method of measurement: Sexual Quality Of Life Questionnaire-Female. Shahid Beheshti University of Medical Sciences Approved 2023-08-01 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran Tehran Tehran Iran (Islamic Republic of)