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IRCT201512023034N16 IRCT 2017-04-14 vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Sciences Effectiveness of Counseling on Sexual Dysfunction of Women with Polycystic Ovarian Syndrome Effectiveness of Sexual Counseling on Sexual Dysfunction of Women with Polycystic Ovarian Syndrome 2017-04-21 anticipated 80 Complete https://irct.ir/trial/3027 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Sexual Dysfunction. Intervention 1: First, the Female sexual Function Index questionnaire (FSFI) will be completed by 80 patients with inclusion criteria in the presence of researcher, individually . Then randomely , patients will be divided into two groups, intervention and control groups in the same time .Intervention for working group include four individual counseling sessions for 60 minutes’ consultations in accordance with PLISSIT model that will be carried out once a week by researcher. The first meeting after introduction and description of the goal of study, the first step (Permission) runs. At this stage, the patient will be allowed to speak about her sexual problems. At this stage, counseling techniques such as listening skills and pay attention to non-verbal gestures will be used and understood false beliefs and knowledge of patients and by collecting history and completed Sexual Function Index questionnaire, their problems will be diagnosised. At second session (Limited Information) which consultant will talk about the anatomy and physiology of the reproductive system and sexual cycle. In addition, explain about the disease, its side effects and its effect on sexual function and for a better understanding, slides and images color will be used. Third session (Specific Suggestion) according to each patient by clients help, suggestions for remission of the disease will be done. For example,sensate focus technique,exersice, massage and etc, due to personal problem will be advised. Last session (Intensive Therapy) is the final step. Patients who pass previous three sessions of counseling are suspected to any mental disorder, a history of rape and etc., will be referred to health professionals. At the end of he each session, summery of that session, will be given to clients such as brochures and booklet. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed. Intervention 2: At the end of intervention, training manual wich contains information about sexual responsive cycle, physiology and anatomy of the genital tract, polycystic ovarian syndrome and its side effects, etc, prepared and will be presented for the control group. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed.
public Fahimeh Golbabaei
Iran University of Medical Sciences, School of Nursing and Midwifery, Rashidyasemi St. , Valiasr St. , Tehran , Iran
Tehran Iran (Islamic Republic of) +98 21 8888 2885 farnaz2006_1000@yahoo.com School Nursing and Midwifery, Iran University of Medical Sciences scientific Dr Mansoureh Jamshidimanesh
Iran University of Medical Sciences, School of Nursing and Midwifery, Rashidyasemi St. , Valiasr St. , Tehran , Iran
Tehran Iran (Islamic Republic of) +98 21 8888 2885 Jamshidimanesh@yahoo.com School Nursing and Midwifery, Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Married; 18_45 years’ old; Iranian; Having at least degree of knowledge; Having sexual activity during past six months; The definitive diagnosis of the polycystic ovarian syndrome by a gynecologist and records in document which is based on the criteria of Rotterdam; Having sexual function score that is less than 28 before intervention; Lack of pregnancy and lactation and unwillingness to be pregnant during intervention; Lack of other acute physical and mental disease and endocrine disorder like thyroid disorders, diabetes based on the patient’s medical document; Lack of consumption alcohol and drugs by patients and her husband according to the patient’s reports; Lack of consumption drugs that are effective on sexual activity like ant depression, antihypertensive drugs...; Lack of consumption of any drugs or hormonal intervention during the last 60 days before intervention; Lack of history of women surgery such as genital surgery and breast surgery; Lack of sexual dysfunction by patient’s husband (according to patients reports); Lack of participation in training classes to counseling for sexual dysfunction; Lack of stressful events that are unrelated to pregnancy Exclusion criteria: Missing one of the session; Occurrences of stressful events that are unrelated to pregnancy no limit no limit Female F52 Sexual dysfunction, not caused by organic disorder or disease Other Treatment - Drugs First, the Female sexual Function Index questionnaire (FSFI) will be completed by 80 patients with inclusion criteria in the presence of researcher, individually . Then randomely , patients will be divided into two groups, intervention and control groups in the same time .Intervention for working group include four individual counseling sessions for 60 minutes’ consultations in accordance with PLISSIT model that will be carried out once a week by researcher. The first meeting after introduction and description of the goal of study, the first step (Permission) runs. At this stage, the patient will be allowed to speak about her sexual problems. At this stage, counseling techniques such as listening skills and pay attention to non-verbal gestures will be used and understood false beliefs and knowledge of patients and by collecting history and completed Sexual Function Index questionnaire, their problems will be diagnosised. At second session (Limited Information) which consultant will talk about the anatomy and physiology of the reproductive system and sexual cycle. In addition, explain about the disease, its side effects and its effect on sexual function and for a better understanding, slides and images color will be used. Third session (Specific Suggestion) according to each patient by clients help, suggestions for remission of the disease will be done. For example,sensate focus technique,exersice, massage and etc, due to personal problem will be advised. Last session (Intensive Therapy) is the final step. Patients who pass previous three sessions of counseling are suspected to any mental disorder, a history of rape and etc., will be referred to health professionals. At the end of he each session, summery of that session, will be given to clients such as brochures and booklet. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed. At the end of intervention, training manual wich contains information about sexual responsive cycle, physiology and anatomy of the genital tract, polycystic ovarian syndrome and its side effects, etc, prepared and will be presented for the control group. Female Sexual Function Index questionnaire for working group, prior, immediately and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire will be completed. Satisfication. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Arousal. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Lubrication. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Orgasm. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Desire. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Sexual Dysfunction. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. Pain. Timepoint: Prior, immediatly and eight weeks after last session of counseling in working group and for control group, eight weeks after filling out the initial questionnaire. Method of measurement: Female Sexual Function Index questionnaire. vice chancellor for Research, School of Nursing and Midwifery, Iran University of Medical Sciences Approved 2017-03-04 Iran University of Medical Sciences Iran University of Medical Sciences, Next to the Milad Tower,Shahid Hemmat Highway, Tehran, Iran Tehran Iran (Islamic Republic of)