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IRCT201206099975N1 IRCT 2012-09-11 Vice chancellor for research, Isfahan University of Medical Sciences Effect of PLISSIT therapeutic model and Sexual Health model on women’s sexual problems A randomized controlled trial of effect of PLISSIT and Sexual Health models on women sexual problems 2012-08-22 anticipated 84 Complete https://irct.ir/trial/10478 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization Scheme: A total of 84 women with history of sexual problems who meet the eligibility criteria, will be randomized into one of the groups. Subjects will be randomized according to a preexisting list produced by the computer program. First group will receive PLISSIT model and Sexual Health model will be implemented for the second group. Both groups will participate in six sessions. All enrolled subjects will be assessed for demographic characteristics, medical history, sexual function and sexual stress. 3 Sexual problems. Intervention 1: PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy) : The subjects in this group will receive five 60- minute therapy sessions. Sessions 1, 2, ۳, 4 and 5 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the five therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge. Intervention 2: Sexual Health model: Second group will receive the gold-standard educational-based sexual health model. This Model includes 10 key components posited to be essential aspects of healthy human sexuality such as talking about sex, culture and sexual identity, sexual anatomy and functioning, sexual health care and safer sex, challenges to sexual health, body image, masturbation and fantasy, positive sexuality, intimacy and relationships, and spirituality. In this group subjects will attend in the five 60-minute group education sessions. Up to 10 women will be participating in each session.
public Farnaz Farnam
Faculty of nursing and midwifery, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) +98 912 242 3154 fz.farnam@ gmail.com Isfahan University of Medical Sciences scientific Farnaz Farnam, Mohsen Janghorban, Effate Merghati
faculty of nursing and midwifery, Isfahan University of Medical Sciences- School of Public Health, Isfahan University of Medical Sciences; School of Public Health, Tehran University of Medical Sciences
Isfahan- Isfahan- Tehran Iran (Islamic Republic of) +98 31 1792 2774 fz.farnam@ gmail.com; janghorbani@ hlth.mui.ac.ir; effat_mer@ yahoo.com Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Tehran University of Iran (Islamic Republic of) Inclusion criteria: presence of problem during the last 2 months, distress score > 11 , healthy women age 20 to 45 years, married and having an intact marriage. Exclusion criteria: alcohol and other form of drug abuse, severe mental disorder such as depression and anxiety, chronic/acute medical disorders that affect on sexuality such as diabetes and heart disease 20 years 45 years Female F52 Sexual dysfunction, not caused by organic disorder or disease Treatment - Other Treatment - Other PLISSIT model (Permission, Limited Information, Specific Suggestions, Intensive Therapy) : The subjects in this group will receive five 60- minute therapy sessions. Sessions 1, 2, ۳, 4 and 5 are all adapted from the PLISSIT treatment model including four therapeutic stages. St1: Permission; client freely talks about her sexual concerns. Permission also is given to those non-problematic sexual behaviors which subject has already experienced. St2: Limited Information; therapist provides patient with limited information about the given problem. St3: Specific Suggestions; specific recommendations are offered enabling patient to manage her sexual problems. The fourth stage: Intensive Therapy; psycho-sexual therapy is performed by the researcher or Co-I psychiatrist. All subjects will be provided the five therapy sessions even if they might not need to receive intensive therapy. Researcher will be in contact with the subjects regularly to avoid missing follow up as well as addressing their concerns related to the therapy. Interventions for the subjects will be free of charge. Sexual Health model: Second group will receive the gold-standard educational-based sexual health model. This Model includes 10 key components posited to be essential aspects of healthy human sexuality such as talking about sex, culture and sexual identity, sexual anatomy and functioning, sexual health care and safer sex, challenges to sexual health, body image, masturbation and fantasy, positive sexuality, intimacy and relationships, and spirituality. In this group subjects will attend in the five 60-minute group education sessions. Up to 10 women will be participating in each session. Sexual distress. Timepoint: At baseline, 2 and 4 months post-intervention. Method of measurement: Female Sexual Distress Scale_Revised ( FSDS_R). Sexual function. Timepoint: At baseline, 2.5 and 7 months post- intervention. Method of measurement: Brief Index of Sexual Function for Women (BISF_W). Vice chancellor for research, Isfahan University of Medical Sciences Approved 2012-05-27 Ethics Committee of Isfahan University of Medical Sciences Third floor, ‌‌‌Building number 4, Hezar jarib St., Isfahan University of Medical Sciences Isfahan Iran (Islamic Republic of)