History
# Registration date Revision Id
3 2021-06-07, 1400/03/17 192895
2 2020-11-07, 1399/08/17 163191
1 2020-06-23, 1399/04/03 140184
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  • Protocol summary

    The sampling center is located in the south of Tehran city. 80 clients who have SIAD enter the study with their husbands.The couple is randomly divided into groups A and B, each of which consists of 40 pairs.couples in Group A receive the same educational content through the Telegram channel in 4 face-to-face sessions And group B receives the same educational content through the Telegram channel.
    The sampling center is located in the south of Tehran city. Of the eligible clients, 40 women with their husbands and 40 women alone with reduced libido are included in the study. Couples are randomly divided into two groups of 40 intervention A and B. Both groups receive an educational content virtually.
    محل نمونه گیری مراکز بهداشتی درمانی جنوب تهران می باشد.از مراجعین واجد معیار های ورود، 80 زن که دچار کاهش میل جنسی می باشند به همراه همسرانشان وارد مطالعه می شوند.زوجین با روش بلوک بندی تصادفی به دو گروه 40 نفری مداخله A و B تقسیم می شوند. .افراد گروه مداخله ی A در 4 جلسه به صورت حضوری و گروه B همان محتوای آموزشی را از طریق کانال تلگرام دریافت می کنند.
    محل نمونه گیری مراکز بهداشتی درمانی جنوب تهران می باشد.از مراجعین واجد معیار های ورود، 40 زن به همراه همسرانشان و 40 زن به صورت تنها که دچار کاهش میل جنسی می باشند وارد مطالعه می شوند.زوجین با روش بلوک بندی تصادفی به دو گروه 40 نفری مداخله A و B تقسیم می شوند. هر دو گروه یک محتوی آموزشی را به صورت مجازی دریافت می کنند.
    Sexual counseling based on the GES model, which will include the following content:(An overview of the anatomy and physiology of the female and male reproductive system, the sexual response cycle, the factors influencing this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge,Explain the importance of sex as an important element of life, creating realistic expectations, emphasizing physical health and healthy behavioral habits on sexual health recovery, training and counseling behavioral exercises (concentration) -counseling to overcome sexual fears and anxieties, .These trainings are in the A group in the form of face-to-face meetings and in the B group in the virtual form and through the Telegram channel.
    Sexual counseling based on the GES model, which will include the following content:(An overview of the anatomy and physiology of the female and male reproductive system, the sexual response cycle, the factors influencing this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge,Explain the importance of sex as an important element of life, creating realistic expectations, emphasizing physical health and healthy behavioral habits on sexual health recovery, training and counseling behavioral exercises (concentration) -counseling to overcome sexual fears and anxieties.In group A, couples and in group B, women are trained. Trainings in both groups are done virtually.
    مشاوره جنسی براساس مدل GES که شامل محتوای زیر خواهد بود: (مروری برآناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، ایجاد انتظارات واقع بینانه،تاکید بر سلامت جسمی و عادات رفتاری سالم بر احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس) و مشاوره جهت غلبه بر ترس ها و نگرانی های جنسی .این آموزش ها در گروه A به صورت جلسات حضوری و در گروه B به صورت مجازی و از طریق کانال تلگرام می باشد.
    مشاوره جنسی براساس مدل GES که شامل محتوای زیر خواهد بود: (مروری برآناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، ایجاد انتظارات واقع بینانه،تاکید بر سلامت جسمی و عادات رفتاری سالم بر احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس) و مشاوره جهت غلبه بر ترس ها و نگرانی های جنسی .در گروه A زوجین و در گروه B زنان آموزش می بینند . آموزش ها در هر دو گروه به صورت مجازی صورت می گیرد.
  • General information

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    Changing the questionnaires and changing the intervention method from face to face to virtual Due to the prevalence Corona virus epidemic
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    تغییر پرسشنامه ها و تغییر روش مداخله از حضوری به مجازی به علت شیوع اپیدمی ویروس کرونا
    Having at least three DSM-5 diagnostic criteria For SIAD And having problems for at least 6 months And In (100-75%) Of sexual intercourse.
    Having Sexual Distress
    The presence of an orgasmic disorder that is less important than the SIAD disorder ( if the orgasmic disorder is more important and primary, it goes away).
    SIAD disorder is secondary, meaning that the person has not had the problem from the beginning with the question, "Have you felt that your sexual desire has decreased compared to before?" Is measured.
    SIAD disorder is generalized, meaning that decreased of Sexual Desire is not just because of the spouse.
    Ability to attend In all training sessions
    Age range 18 years before menopause
    Spouse presence in the past month provided you have sex
    Lack of addiction in the participant and his wife
    Lack of recent emotional crisis in life
    Having at least three DSM-5 diagnostic criteria For SIAD And having problems for at least 6 months And In (100-75%) Of sexual intercourse.
    Having Sexual Distress
    The presence of an orgasmic disorder that is less important than the SIAD disorder ( if the orgasmic disorder is more important and primary, it goes away).
    SIAD disorder is secondary, meaning that the person has not had the problem from the beginning with the question, "Have you felt that your sexual desire has decreased compared to before?" Is measured.
    SIAD disorder is generalized, meaning that decreased of Sexual Desire is not just because of the spouse.
    Age range 18 years before menopause
    Spouse presence in the past month provided you have sex
    Lack of addiction in the participant and his wife
    Lack of recent emotional crisis in life
    داشتن حداقل سه مورد از معیارهای تشخیصی DSM-5 برای کاهش میل جنسی و داشتن مشکل به مدت حداقل 6 ماه و در (100-75%) برخورد های جنسی
    داشتن دیسترس جنسی
    وجود اختلال ارگاسم که اهمیت آن کمتر از اختلال SIAD بوده و یا بعد از آن بوجود آمده است( اما اگر اختلال ارگاسم مهم تر و اولیه باشد خارج می شود).
    اختلال SIAD از نوع ثانویه باشد به این معنی که فرد از ابتدا این مشکل را نداشته است و با یک سوال" آیا احساس کرده اید که میل جنسی شما نسبت به قبل کاهش یافته است؟" سنجیده می شود.
    اختلالSIAD از نوع عمومی(Generalized) باشد به این معنی که کاهش میل جنسی تنها به خاطر همسر نباشد.
    توانایی شرکت در همه ی جلسات آموزشی
    محدوده ی سنی 18 سال تا قبل از یائسگی
    حضور همسر در یک ماه گذشته به شرط داشتن رابطه جنسی
    فقدان اعتیاد در شرکت کننده و همسرش
    نبود بحران عاطفی اخیر در زندگی
    داشتن حداقل سه مورد از معیارهای تشخیصی DSM-5 برای کاهش میل جنسی و داشتن مشکل به مدت حداقل 6 ماه و در (100-75%) برخورد های جنسی
    داشتن دیسترس جنسی
    وجود اختلال ارگاسم که اهمیت آن کمتر از اختلال SIAD بوده و یا بعد از آن بوجود آمده است( اما اگر اختلال ارگاسم مهم تر و اولیه باشد خارج می شود).
    اختلال SIAD از نوع ثانویه باشد به این معنی که فرد از ابتدا این مشکل را نداشته است و با یک سوال" آیا احساس کرده اید که میل جنسی شما نسبت به قبل کاهش یافته است؟" سنجیده می شود.
    اختلالSIAD از نوع عمومی(Generalized) باشد به این معنی که کاهش میل جنسی تنها به خاطر همسر نباشد.
    محدوده ی سنی 18 سال تا قبل از یائسگی
    حضور همسر در یک ماه گذشته به شرط داشتن رابطه جنسی
    فقدان اعتیاد در شرکت کننده و همسرش
    نبود بحران عاطفی اخیر در زندگی
    Menopause
    having depression : Diagnosis with questionnaire 2 PHQ-2 questionnaire
    presence of chronic and severe diseases affecting sexual issues
    taking any drug that affects sexual desire such as antidepressants
    having serious marital problems with the spouse that may lead to divorce
    Sexual pain
    unwillingness to continue participating in the Intervention
    not attending In 2 or more counseling sessions
    Menopause
    having depression : Diagnosis with questionnaire 2 PHQ-2 questionnaire
    presence of chronic and severe diseases affecting sexual issues
    taking any drug that affects sexual desire such as antidepressants
    having serious marital problems with the spouse that may lead to divorce
    Sexual pain
    unwillingness to continue participating in the Intervention
    یائسگی
    داشتن افسردگی : تشخیص با پرسشنامه 2 سوالی PHQ-2
    حضور بیماری های مزمن و شدید موثر بر مسائل جنسی
    مصرف هر گونه داروی اثرگذار بر میل جنسی مانند داروهای ضد افسردگی
    دارا بودن مشکلات جدی زناشویی با همسر که ممکن است به طلاق منجر شود
    درد جنسی
    عدم تمایل برای ادامه مشارکت در مداخله
    عدم حضور در 2یا بیش از 2جلسه مشاوره
    یائسگی
    داشتن افسردگی : تشخیص با پرسشنامه 2 سوالی PHQ-2
    حضور بیماری های مزمن و شدید موثر بر مسائل جنسی
    مصرف هر گونه داروی اثرگذار بر میل جنسی مانند داروهای ضد افسردگی
    دارا بودن مشکلات جدی زناشویی با همسر که ممکن است به طلاق منجر شود
    درد جنسی
    عدم تمایل برای ادامه مشارکت در مداخله
    Accidental allocation to intervention and control groups: Describe how to randomize: Eighty women with SIAD who are eligible to Intervention are selected with their spouses to enter the study. These Couples are then randomly divided into two groups of 40 pairs of intervention A and intervention B using random blocking with the size of four blocks. For random allocation by blocking method and allocating individuals to 2 intervention groups (A) and Intervention B (B), there are six modes for blocks, including: ABAB ،BBAA, AABB, BABA, ABBA and BAAB. We create random numbers using a computer. For the number 1 of the combination 1 (BAAB), for the number 2 the combination 2 (BBAA), for the number 3 of the combination 3 (ABBA), for the number 4 of the combination 4 (ABAB), for the number 5 of the combination 5 (BAAB) and for the number 6 of We use a combination of 6 (AABB).
    Random assignment to intervention and control groups Description of how to randomize: 80 women with eligibility criteria(SIAD) who meet the inclusion criteria are selected. 40 women participate in the study with their husbands (couples) and 40 women individually. Then, these two groups are randomly divided into two groups of 40 (even) and 40 women, using intervention A and intervention B, using random block sizes of four blocks. For random allocation by block method and assigning individuals to 2 intervention groups (A) and intervention group (B), there are six modes for blocks, including: AABB, ABAB, ABBA, BBAA, BABA and BAAB. We create random numbers using a computer .For number 1 of combination 1 (BAAB), for number 2 of combination 2 (BBAA), for number 3 of combination 3 (ABBA), for number 4 of combination 4 (ABAB), for number 5 of combination 5 (BAAB) and for Number 6 We use combination 6 (AABB).
    تخصیص تصادفی به گروه‌های مداخله و کنترل توصیف نحوه تصادفی سازی: از زنان مراجعه کننده دارای اختلال کاهش میل جنسی 80 نفر که دارای معیارهای ورود به مطالعه هستند به همراه همسرشان برای ورود به مطالعه انتخاب میشوند. سپس این زوجین به صورت تصادفی با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به دو گروه 40زوجی مداخله ی A و مداخله ی B تقسیم میشوند. برای تخصیص تصادفی با روش بلوک بندی و تخصیص افراد به 2 گروه مداخله(A) و گروه مداخله (B) ، شش حالت برای بلوک ها وجود دارد، شامل : AABB، ABAB،ABBA ،BBAA،BABA و BAAB. با استفاده از کامپیوتر اعداد تصادفی ایجاد میکنیم. برای عدد1 از ترکیب 1 (BAAB ) ، برای عدد 2 از ترکیب 2 (BBAA) ، برای عدد 3 از ترکیب 3 (ABBA)، برای عدد 4 از ترکیب 4 (ABAB) ، برای عدد 5 از ترکیب 5(BAAB) و برای عدد6 از ترکیب 6 ( AABB) استفاده میکنیم.
    تخصیص تصادفی به گروه‌های مداخله و کنترل توصیف نحوه تصادفی سازی: از زنان مراجعه کننده دارای اختلال کاهش میل جنسی 80 نفر که دارای معیارهای ورود به مطالعه هستند انتخاب میشوند. 40 زن به همراه همسرشان ( زوج) و 40 زن به صورت منفرد در مطالعه شرکت می کنند . سپس این دو گروه به صورت تصادفی با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به دو گروه 40 (زوج) و 40 زن و به عبارتی مداخله ی A و مداخله ی B تقسیم میشوند. برای تخصیص تصادفی با روش بلوک بندی و تخصیص افراد به 2 گروه مداخله(A) و گروه مداخله (B) ، شش حالت برای بلوک ها وجود دارد، شامل : AABB، ABAB،ABBA ،BBAA،BABA و BAAB. با استفاده از کامپیوتر اعداد تصادفی ایجاد میکنیم. برای عدد1 از ترکیب 1 (BAAB ) ، برای عدد 2 از ترکیب 2 (BBAA) ، برای عدد 3 از ترکیب 3 (ABBA)، برای عدد 4 از ترکیب 4 (ABAB) ، برای عدد 5 از ترکیب 5(BAAB) و برای عدد6 از ترکیب 6 ( AABB) استفاده میکنیم.
  • Primary outcomes

    #1
    Sexual Interest/Arousal Disorders
    Sexual Desire
    کاهش میل جنسی
    میل جنسی
    #2
    The Female Sexual Function Index
    The Female Sexual Function Index(19)
    پرسشنامه مقیاس عملکرد جنسی زنان
    پرسشنامه مقیاس عملکرد جنسی زنان(19)
    #3
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    The Sexual Satisfaction
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    رضایت جنسی
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    Before intervention and 3 months after intervention
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    قبل از مداخله و 3 ماه پس از مداخله
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    The Global Measure of Sexual Satisfaction
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    پرسشنامه سنجش سطح کلی رضایت جنسی
  • Secondary outcomes

    #1
    Wrong sexual beliefs
    Sexual Distress
    عقاید جنسی غلط
    دیسترس جنسی
    قبل از شروع مداخله و 3 ماه پس از پایان مداخله
    قبل از شروع مداخله و 3 ماه پس از پایان مداخله
    The Sexual Dysfunction Beliefs Questionnaire
    The Female Sexual Distress Scale-Revised(13)
    پرسشنامه ی عقاید جنسی غلط
    شاخص بازبینی شده دیسترس جنسی زنان(13)
    #2
    Sexual Distress
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    دیسترس جنسی
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    Before Intervention And 3 Months After The End Of The Intervention
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    قبل از شروع مداخله و 3 ماه پس از پایان مداخله
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    The Female Sexual Distress Scale-Revised
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    شاخص بازبینی شده دیسترس جنسی زنان
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    #3
    The Sexual Satisfaction Events
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    پیشامدهای جنسی رضایت بخش
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    One month Before and one month after the intervention
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    یک ماه قبل و یک ماه پس از از مداخله
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    Sexual Satisfaction Events
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    پرسشنامه پیشامد های جنسی رضایت بخش
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    #4
    Sexual Satisfaction
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    رضایت جنسی
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    Before Intervention And 3 Months After The End Of The Intervention
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    قبل از شروع مداخله و 3 ماه پس از پایان مداخله
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    Index Of Sexual Satisfaction
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    مقیاس رضایت جنسی
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  • Intervention groups

    #1
    Intervention Group A: These individuals undergo sexual counseling and training in 4 face-to-face sessions based on the concepts of GES treatment model. The content of the first and second sessions includes an overview of anatomy and physiology of the female and male reproductive system, sexual response cycle, factors Affecting this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge, explaining the importance of sex as an important element of life, the importance of quality and sexual satisfaction in couples' sexual development and the third and fourth sessions on realistic expectations, physical health And healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome sexual fears and anxieties, and training to have flexible sexual experiences, etc.) are emphasized based on the dimensions of the treatment model.
    Intervention group A: couples receive sexual counseling and training in 4 virtual sessions per week for 90 minutes based on the concepts of the treatment model.. The content of the first and second sessions includes an overview of anatomy and physiology of the female and male reproductive system, sexual response cycle, factors Affecting this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge, explaining the importance of sex as an important element of life, the importance of quality and sexual satisfaction in couples' sexual development and the third and fourth sessions on realistic expectations, physical health And healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome sexual fears and anxieties, and training to have flexible sexual experiences, etc.) are emphasized based on the dimensions of the treatment model.
    گروه مداخله A:این افراد در 4 جلسه ی حضوری طی 4 هفته تحت مشاوره و آموزش جنسی بر اساس مفاهیم مدل درمانی GES قرار می گیرند.محتوی جلسه اول و دوم شامل مروری برآناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، اهمیت کیفیت و رضایت جنسی در رشد جنسی زوجین و جلسه سوم و چهارم بر ایجاد انتظارات واقع بینانه، سلامت جسمی و عادات رفتاری سالم برای احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس)، مشاوره در جهت غلبه بر ترس ها و نگرانی های جنسی و آموزش داشتن تجارب جنسی انعطاف پذیر و غیره) بر اساس ابعاد مدل درمانی تاکید می شود.
    گروه مداخله A:زوجین در 4 جلسه ی مجازی 90 دقیقه ای، طی 4 هفته تحت مشاوره و آموزش جنسی بر اساس مفاهیم مدل درمانی GES قرار می گیرند.محتوی جلسه اول و دوم شامل مروری برآناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، اهمیت کیفیت و رضایت جنسی در رشد جنسی زوجین و جلسه سوم و چهارم بر ایجاد انتظارات واقع بینانه، سلامت جسمی و عادات رفتاری سالم برای احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس)، مشاوره در جهت غلبه بر ترس ها و نگرانی های جنسی و آموزش داشتن تجارب جنسی انعطاف پذیر و غیره) بر اساس ابعاد مدل درمانی تاکید می شود.
    #2
    Intervention Group B: These individuals Content of sex education that includes an overview of the anatomy and physiology of the male and female reproductive system, the sexual response cycle, the factors influencing this cycle and the factors affecting the reduction of women's sexual desire and the need for sexual self-knowledge. The title of the important element of life, the importance of quality and sexual satisfaction in sexual development of couples, creating realistic expectations, having physical health and healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome fears and Sexual worries and learning to have flexible sexual experiences, etc.) are received through the Telegram channel and virtually.
    Intervention group B: Women containing sexual education and counseling, which includes an overview of the anatomy and physiology of the male and female reproductive system, sexual response cycle, factors affecting this cycle and factors affecting the reduction of female libido and the need for sexual self-knowledge Sex as an important element of life, the importance of quality and sexual satisfaction in the sexual development of couples, creating realistic expectations, having physical health and healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (mindfulness), counseling to overcome fear Sexual concerns and training to have flexible sexual experiences, etc.) are received virtually as in group A in 4 weekly sessions.
    گروه مداخله B:این افراد محتوی آموزشی جنسی که شامل مروری بر آناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی ، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، اهمیت کیفیت و رضایت جنسی در رشد جنسی زوجین ، ایجاد انتظارات واقع بینانه، داشتن سلامت جسمی و عادات رفتاری سالم برای احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس)، مشاوره در جهت غلبه بر ترس ها و نگرانی های جنسی و آموزش داشتن تجارب جنسی انعطاف پذیر و غیره) می باشد را از طریق کانال تلگرام و به صورت مجازی دریافت می کنند.
    گروه مداخله B:زنان محتوی آموزش و مشاوره ی جنسی که شامل مروری بر آناتومی و فیزیولوژی دستگاه تناسلی زن و مرد،سیکل پاسخ جنسی ،عوامل اثر گذار بر این سیکل و عوامل موثر بر ایجاد کاهش میل جنسی زنان و لزوم خودشناسی جنسی ، تشریح اهمیت سکس به عنوان عنصر مهم زندگی، اهمیت کیفیت و رضایت جنسی در رشد جنسی زوجین ، ایجاد انتظارات واقع بینانه، داشتن سلامت جسمی و عادات رفتاری سالم برای احیای سلامت جنسی، آموزش و مشاوره تمرینات رفتاری (تمرکز حواس)، مشاوره در جهت غلبه بر ترس ها و نگرانی های جنسی و آموزش داشتن تجارب جنسی انعطاف پذیر و غیره) می باشد را همانند گروه A در 4 جلسه ی هفتگی به صورت مجازی دریافت میکنند.
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Tehran University of Medical Science
    Name of organization / entity - Persian: عاونت پژوهشی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی تهران
    Full name of responsible person - English: محمد علی صحرائیان
    Full name of responsible person - Persian: Mohammad Ali Sahraian
    Street address - English: Tohid Square، Nosrat st,Tehran, Reproductive Health Department, Tehran University of Medical sciences
    Street address - Persian: میدان توحید، خیابان نصرت، دانشگاه علوم پزشکی تهران،گروه سلامت باروری
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733181
    Phone: +98 21 6105 4000
    Fax:
    Email: zfarahi1374@gmail.com
    Web page address: http://fnm.tums.ac.ir
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Tehran University of Medical Science
    Name of organization / entity - Persian: عاونت پژوهشی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی تهران
    Full name of responsible person - English: Mohammad Ali Sahraian
    Full name of responsible person - Persian: محمد علی صحرائیان
    Street address - English: School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
    Street address - Persian: ميدان توحيد، خيابان دکتر میرخانی (نصرت شرقی)، دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733181
    Phone: +98 21 6105 4000
    Fax:
    Email: zfarahi1374@gmail.com
    Web page address: http://fnm.tums.ac.ir

Protocol summary

Study aim
Determination of the effect of sexual counseling based on GES model on On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction.
Design
Randomized Controlled Trial with parallel groups
Settings and conduct
The sampling center is located in the south of Tehran city. Of the eligible clients, 40 women with their husbands and 40 women alone with reduced libido are included in the study. Couples are randomly divided into two groups of 40 intervention A and B. Both groups receive an educational content virtually.
Participants/Inclusion and exclusion criteria
Inclution Criteria: Having at least three DSM-5 diagnostic criteria For SIAD having dysfunction for at least 6 months and in ( 75-100%) Of sexual intercourse having sexual distress the absence of a recent emotional crisis in life exclution criteria: menopause the presence of chronic diseases affecting sexual issues
Intervention groups
Sexual counseling based on the GES model, which will include the following content:(An overview of the anatomy and physiology of the female and male reproductive system, the sexual response cycle, the factors influencing this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge,Explain the importance of sex as an important element of life, creating realistic expectations, emphasizing physical health and healthy behavioral habits on sexual health recovery, training and counseling behavioral exercises (concentration) -counseling to overcome sexual fears and anxieties.In group A, couples and in group B, women are trained. Trainings in both groups are done virtually.
Main outcome variables
Sexual Interest And Arousal Disorders

General information

Reason for update
Changing the questionnaires and changing the intervention method from face to face to virtual Due to the prevalence Corona virus epidemic
Acronym
GES
IRCT registration information
IRCT registration number: IRCT20120609009975N9
Registration date: 2020-06-23, 1399/04/03
Registration timing: prospective

Last update: 2020-12-15, 1399/09/25
Update count: 2
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Farnaz Farnam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4217
Email address
fz.farnam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of sexual counseling based on GES model on On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction
Public title
Determination of the effect of sexual counseling On Sexual satisfaction And Sexual Function of Couple with Sexual Dysfunction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least three DSM-5 diagnostic criteria For SIAD And having problems for at least 6 months And In (100-75%) Of sexual intercourse. Having Sexual Distress The presence of an orgasmic disorder that is less important than the SIAD disorder ( if the orgasmic disorder is more important and primary, it goes away). SIAD disorder is secondary, meaning that the person has not had the problem from the beginning with the question, "Have you felt that your sexual desire has decreased compared to before?" Is measured. SIAD disorder is generalized, meaning that decreased of Sexual Desire is not just because of the spouse. Age range 18 years before menopause Spouse presence in the past month provided you have sex Lack of addiction in the participant and his wife Lack of recent emotional crisis in life
Exclusion criteria:
Menopause having depression : Diagnosis with questionnaire 2 PHQ-2 questionnaire presence of chronic and severe diseases affecting sexual issues taking any drug that affects sexual desire such as antidepressants having serious marital problems with the spouse that may lead to divorce Sexual pain unwillingness to continue participating in the Intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups Description of how to randomize: 80 women with eligibility criteria(SIAD) who meet the inclusion criteria are selected. 40 women participate in the study with their husbands (couples) and 40 women individually. Then, these two groups are randomly divided into two groups of 40 (even) and 40 women, using intervention A and intervention B, using random block sizes of four blocks. For random allocation by block method and assigning individuals to 2 intervention groups (A) and intervention group (B), there are six modes for blocks, including: AABB, ABAB, ABBA, BBAA, BABA and BAAB. We create random numbers using a computer .For number 1 of combination 1 (BAAB), for number 2 of combination 2 (BBAA), for number 3 of combination 3 (ABBA), for number 4 of combination 4 (ABAB), for number 5 of combination 5 (BAAB) and for Number 6 We use combination 6 (AABB).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee In Research, School of Nursing And Midwifery, Tehran University of Medical Sciences
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.TUMS.FNM.REC.1399.035

Health conditions studied

1

Description of health condition studied
Female Sexual Interest/Arousal Disorders
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder

2

Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

3

Description of health condition studied
Sex Counseling
ICD-10 code
Z70.9
ICD-10 code description
Sex counseling, unspecified

Primary outcomes

1

Description
Sexual Desire
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
The Sexual Interest And Desire Inventory

2

Description
sexual function
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
The Female Sexual Function Index(19)

3

Description
The Sexual Satisfaction
Timepoint
Before intervention and 3 months after intervention
Method of measurement
The Global Measure of Sexual Satisfaction

Secondary outcomes

1

Description
How couples Sexualy Interact
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
Dyadic Sexual Communication Scale

2

Description
Sexual Distress
Timepoint
Before Intervention And 3 Months After The End Of The Intervention
Method of measurement
The Female Sexual Distress Scale-Revised(13)

Intervention groups

1

Description
Intervention group A: couples receive sexual counseling and training in 4 virtual sessions per week for 90 minutes based on the concepts of the treatment model.. The content of the first and second sessions includes an overview of anatomy and physiology of the female and male reproductive system, sexual response cycle, factors Affecting this cycle and the factors influencing the reduction of women's sexual desire and the need for sexual self-knowledge, explaining the importance of sex as an important element of life, the importance of quality and sexual satisfaction in couples' sexual development and the third and fourth sessions on realistic expectations, physical health And healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (concentration), counseling to overcome sexual fears and anxieties, and training to have flexible sexual experiences, etc.) are emphasized based on the dimensions of the treatment model.
Category
Behavior

2

Description
Intervention group B: Women containing sexual education and counseling, which includes an overview of the anatomy and physiology of the male and female reproductive system, sexual response cycle, factors affecting this cycle and factors affecting the reduction of female libido and the need for sexual self-knowledge Sex as an important element of life, the importance of quality and sexual satisfaction in the sexual development of couples, creating realistic expectations, having physical health and healthy behavioral habits to restore sexual health, training and counseling behavioral exercises (mindfulness), counseling to overcome fear Sexual concerns and training to have flexible sexual experiences, etc.) are received virtually as in group A in 4 weekly sessions.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Southern Health Centers
Full name of responsible person
Farnaz Farnam
Street address
South Kargar Street
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Fax
Email
f_farnam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Science
Full name of responsible person
Mohammad Ali Sahraian
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 6105 4000
Email
zfarahi1374@gmail.com
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Farahi
Position
Master of Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
zfarahi1374@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Assistant Professor in Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Dr. Mirkhani St, Tohid Square, School of Nursing and Midwifery,Tehran
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
f_farnam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Farahi
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing Midwifery, Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
zfarahi1374@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We're going to publish the results and not distribute the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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