History
# Registration date Revision Id
2 2023-10-08, 1402/07/16 282908
1 2023-04-26, 1402/02/06 262826
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  • Protocol summary

    Comparison of effectiveness sex counseling based on the GES model and the PLISSIT model on the sexual problems of menopausal women
    Comparison of effectiveness sex counseling based on the GES and PLISSIT models on the sexual problems of menopausal women
    Randomized controlled clinical trial
    A controlled clinical trial with a control group, with parallel groups, double blind, randomized, on 108 postmenopausal women, block randomization method was used for randomization.
    کارآزمایی بالینی تصادفی شاهددار
    کارآزمایی بالینی مورد شاهدی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، بر روی ۱۰۸ زن یائسه، برای تصادفی سازی از روش تصادفی سازی بلوکی (Block Randomization) استفاده شد.
    The list of all women aged 45-60 in selected Urmia health center is prepared from the Sib system and each one of them will be contacted by phone and if they agree, In the face-to-face visit at the relevant health centers, women will complete the FSFI questionnaire. If they FSFI score less than 28, they will be included in the study after obtaining written informed consent. Then, they completed Larson's sexual satisfaction instruments, women's sexual quality of life (SQOL-F), sexual intimacy and then randomly assigned to groups A, B, and C.
    The list of all women aged 45 to 60 in the selected Urmia health center has been prepared and each of them will be contacted by phone, and if they are satisfied in visiting the relevant health care centers, the women will complete the FSFI questionnaire. If the FSFI score is less than 28, they will be included in the study after obtaining written informed consent. Then they completed Larson's sexual satisfaction instruments, women's sexual quality of life (SQOL-F), sexual intimacy, and then they were randomly assigned to groups A, B, and C.
    لیست کلیه زنان 45 تا 60 ساله مرکز بهداشت منتخب ارومیه از سامانه سیب تهیه شده و با هر یک از آنها تلفنی تماس گرفته خواهد شد و در صورت رضایت در مراجعه حضوری به مراکز بهداشتی درمانی مربوطه، زنان پرسشنامه FSFI را تکمیل خواهند کرد. اگر امتیاز FSFI کمتر از 28 باشد، پس از کسب رضایت آگاهانه کتبی در مطالعه گنجانده خواهند شد. سپس ابزارهای رضایت جنسی لارسون، کیفیت زندگی جنسی زنان (SQOL-F)، صمیمیت جنسی را تکمیل کردند و سپس به‌طور تصادفی در گروه‌های A، B و C قرار گرفتند.
    لیست کلیه زنان 45 تا 60 ساله مرکز بهداشت منتخب ارومیه تهیه شده و با هر یک از آنها تلفنی تماس گرفته خواهد شد و در صورت رضایت در مراجعه حضوری به مراکز بهداشتی درمانی مربوطه، زنان پرسشنامه FSFI را تکمیل خواهند کرد. اگر امتیاز FSFI کمتر از 28 باشد، پس از کسب رضایت آگاهانه کتبی در مطالعه گنجانده خواهند شد. سپس ابزارهای رضایت جنسی لارسون، کیفیت زندگی جنسی زنان (SQOL-F)، صمیمیت جنسی را تکمیل کردند و سپس به‌طور تصادفی در گروه‌های A، B و C قرار گرفتند.
    Inclusion Criteria: women in age range between 45 and 60 years; being married; complete cessation of menstruation in the last 12 months without the use of drugs or surgery; Literacy of reading and writing; Being monogamy; having a stable sexual relationship in the last 4 weeks; scoring less than 28 in the Female Sexual Function Index (FSFI); Exclusion Criteria: addicted to drugs and alcohol; participating in any educational-counseling classes before or during the study; history of chronic physical and mental illness with self-report.
    Inclusion Criteria: Women in age range between 45 and 60 years; Being married; Complete cessation of menstruation in the last 12 months without the use of drugs or surgery; Literacy of reading and writing; Being monogamy; Having a stable sexual relationship in the last 4 weeks; scoring less than 28 in the Female Sexual Function Index (FSFI); Exclusion Criteria: Addicted to drugs and alcohol; Participating in any educational-counseling classes before or during the study; History of chronic physical and mental illness with self-report.
    Intervention group A will be treated based on the GES model. Intervention group B will be treated based on the PLISSIT model individually. The duration of treatment for both groups is similar, 4 sessions, once a week for 60 minutes. The control group does not receive any counseling intervention, and finally, after the end of the intervention and evaluations, to comply with ethical considerations, the contents of the counseling will be available to the group.
    Intervention group A will be treated based on the GES model. Intervention group B will be treated based on the PLISSIT model individually. The control group does not receive any counseling intervention and finally, after the end of the intervention, in order to comply with ethical considerations, the contents of the counseling will be provided to the group.
    گروه مداخله A تحت درمان مبتنی بر مدل GES قرار خواهد گرفت. گروه مداخله B بر اساس مدل PLISSIT به صورت جداگانه دریافت می کند. مدت زمان درمان برای هر دو گروه مشابه، 4 جلسه، یک بار در هفته به مدت 60 دقیقه است. گروه کنترل هیچ گونه مداخله مشاوره ای دریافت نمی کند و در نهایت پس از پایان مداخله و ارزیابی ها برای رعایت ملاحظات اخلاقی، مطالب مندرج در مشاوره در اختیار گروه قرار خواهد گرفت.
    گروه مداخله A تحت درمان مبتنی بر مدل GES قرار خواهد گرفت. گروه مداخله B بر اساس مدل PLISSIT به صورت جداگانه دریافت می کند. گروه کنترل هیچ گونه مداخله مشاوره ای دریافت نمی کند و در نهایت پس از پایان مداخله برای رعایت ملاحظات اخلاقی، مطالب مندرج در مشاوره در اختیار گروه قرار خواهد گرفت.
    sexual satisfaction, quality of sexual life
    Sexual satisfaction, Quality of sexual life
    رضایت جنسی;کیفیت زندگی جنسی
    رضایت جنسی; کیفیت زندگی جنسی
  • General information

    empty
    At the beginning of the study, two centers were selected as medical centers, and to speed up the study process, two medical centers were added to the list of diagnostic centers. A total of four centers were considered as study centers.
    empty
    در ابتدای مطالعه دو مرکز به عنوان مرکز بیماریابی انتخاب شده بود برای سریعتر انجام شدن روند مطالعه دو مرکز بیماریابی به لیست مراکز بیماریابی اضافه شد. در مجموع چهار مرکز به عنوان مراکز بیماریابی مطالعه در نظر گرفته شد.
    Informed written consent to participate in the study
    complete cessation of menstruation in the last 12 months without the use of drugs or surgery
    Literacy of reading and writing
    Spouse's availability in the last 4 weeks and having sex
    scoring less than 28 on the Female Sexual Function Index (FSFI)
    Having documents in health-care centers in Uromiyeh city
    Married women between 45 to 60 years old
    Being monogamy
    Informed written consent to participate in the study
    Complete cessation of menstruation in the last 12 months without the use of drugs or surgery
    Literacy of reading and writing
    Spouse's availability in the last 4 weeks and having sex
    Scoring less than 28 on the Female Sexual Function Index (FSFI)
    Having documents in health-care centers in Uromiyeh city
    Married women between 45 to 60 years old
    Being monogamy
    random assignment to one of the three study groups; (three groups A, B and C), the block randomization method with block size of 6 will be used. Then, according to the block randomization protocol (Randomization list using statistical program in R software environment version 3.6.1), the participants will be divided into one of the three groups: GES, PLISSIT, and the control group; They will be allocated with a ratio of 1:1:1, so that the researcher cannot predict which group the next person will be placed in the intervention group in each center. The participants are allocated to three groups of 36 people.
    Random assignment to one of the three study groups; (three groups A, B and C), the block randomization method with block size of 6 will be used. Then, according to the block randomization protocol (Randomization list using statistical program in R software environment version 3.6.1), the participants will be divided into one of the three groups: GES, PLISSIT, and the control group; They will be allocated with a ratio of 1:1:1, so that the researcher cannot predict which group the next person will be placed in the intervention group in each center. The participants are allocated to three groups of 36 people.
  • Primary outcomes

    #1
    female sexual function
    Female sexual function
    before the start of the intervention and two months after the end of the intervention
    Before the start of the intervention and two months after the end of the intervention
    #2
    before the start of the intervention and two months after the end of the intervention
    Before the start of the intervention and two months after the end of the intervention
  • Secondary outcomes

    #1
    before the start of the intervention and two months after the end of the intervention
    Before the start of the intervention and two months after the end of the intervention
    #2
    sexual intimacy
    Sexual intimacy
    before the start of the intervention and two months after the end of the intervention
    Before the start of the intervention and two months after the end of the intervention
  • Intervention groups

    #1
    Intervention first group: in this group, women will receive sexual counseling in 4 sessions, 60 minutes, once a week, based on the concepts of the GES treatment model in a group (maximum 8 people). One session of these sexual counseling sessions is considered as individual counseling based on the client's problem and to answer their private questions. The content of the first and second sessions includes an overview of the anatomy and physiology of the male and female reproductive system, false sexual beliefs, the definition of sexual satisfaction and the factors affecting it, the dimensions of correct sexual communication and the definition of sexual self-knowledge, sexual self-disclosure, sexual differences between men and women, the cycle Sexual response, proper conditions for correct sexual intercourse and sexual deviations. The third and fourth session on designing sexual relations based on the conditions of each couple and their desires, methods of creating diversity in sexual relations, definition of sexual fantasy, definition of sexual desire, definition of disorder of decreased desire and sexual stimulation, factors affecting sexual desire, description Physical and psychological factors affecting sexual desire, the description of social-educational and interpersonal factors affecting sexual desire will be emphasized based on the dimensions of the therapeutic model.
    Intervention first group: in this group, women will receive sexual counseling in 4 sessions, 60 minutes, once a week, based on the concepts of the GES treatment model in a group (maximum 8-10 people). The first session of implementing the first three dimensions of the GES model and explaining the importance of sexual activity, teaching the definition of satisfaction and sexual performance and the factors affecting it, explaining the 4 stages of the sexual response cycle with an emphasis on the importance of knowing the sexual "desire" cycle, explaining the effect of menopause on sexual performance and its mechanism, encouraging the participants to write down their needs and expectations from sex, correcting misconceptions and superstitions about sex and creating an optimistic attitude. GES model, teaching healthy eating and performing Kegel exercises, teaching meditation skills and concentration exercises and three-minute breathing exercises, providing a time table to note down one's thoughts and mentality during pleasant and desirable sexual experiences, unpleasant experiences, dislike, Pain and contraction in body muscles, learning to enjoy each other. The third session of implementing the 7th, 8th and 9th dimensions of the GES model, taking into consideration the problems and concerns noted by the clients during the previous weeks, counseling for the appearance of adaptation to anatomical changes, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance Flirting and making love of couples, explaining and examining the pattern of sexual changes and possible physical problems after menopause and focusing on the five goals in Kamesh, identifying the five principles for sexual relations, accepting multiple goals from the parties, avoiding one-sided and inflexible goals. and clarifying the sexual program, describing different positions of intimacy and sexual stimulation styles, combining styles and creating diversity in the relationship. The fourth session of the implementation of the 10th, 11th and 12th dimensions of the GES model, counseling and training about the physical and psychological differences between men and women in each of the stages of the sexual cycle, communication skills training, creation skills training and maintaining intimacy.
    گروه مداخله اول: در این گروه زنان مشاوره جنسی را در طی 4 جلسه، 60 دقیقه ای، هفته ای یکبار، براساس مفاهیم مدل درمانی کامش در حد کافی (GES) به صورت گروهی ( حداکثر 8 نفر ) دریافت خواهند کرد. یک جلسه از این جلسات مشاوره جنسی به صورت مشاوره فردی مبتنی بر مشکل مددجو و برای پاسخ به سوالات خصوصی آنها در نظر گرفته می شود. محتوی جلسه اول و دوم شامل مروری بر آناتومی و فیزیولوژی دستگاه تناسلی زن و مرد، عقاید جنسی غلط، تعریف رضایت جنسی و عوامل موثر بر آن، ابعاد ارتباط جنسی صحیح و تعریف خودشناسی جنسی، خود افشاگری جنسی، تفاوت های جنسی زن و مرد، سیکل پاسخ جنسی، شرایط مناسب ارتباط جنسی صحیح و انحرافات جنسی. جلسه سوم و چهارم بر طراحی رابطه ی جنسی بر اساس شرایط هر زوج و خواسته های آنها، روش های ایجاد تنوع در رابطه ی جنسی، تعریف فانتزی جنسی، تعریف میل جنسی، تعریف اختلال کاهش میل و تحریک جنسی، فاکتورهای موثر بر میل جنسی، شرح عوامل جسمی و روانشناختی موثر بر میل جنسی، شرح عوامل اجتماعی- تربیتی و بین فردی موثر میل جنسی بر اساس ابعاد مدل درمانی مورد تاکید قرار خواهد گرفت.
    گروه مداخله اول: در این گروه زنان مشاوره جنسی را در طی 4 جلسه، 60 دقیقه ای، هفته ای یکبار، براساس مفاهیم مدل درمانی کامش در حد کافی (GES) به صورت گروهی ( حداکثر 8-10 نفر ) دریافت خواهند کرد. جلسه اول اجرای سه بعد اول مدل GES و توضیح اهمیت فعالیت جنسی، آموزش تعریف رضایت و عملکرد جنسی و عوامل مؤثر بر آن،تشریح مراحل 4 گانه سیکل پاسخ جنسی با تاکید بر اهمیت شناخت چرخه "تمایل" جنسی، تبیین تاثیر یائسگی بر عملکرد جنسی و مکانیسم آن ،ترغیب مشارکت کنندگان به نوشتن نیازها و انتظاراتشان از رابطه جنسی، اصلاح باورهای غلط و خرافات در مورد رابطه جنسی و ایجاد نگرش خوش بینانه.جلسه دوم مروری بر آموخته ها و خلاصه ی جلسه قبل و اجرای ابعاد چهار، پنج و شش مدل GES، آموزش تغذیه سالم و انجام تمرینات کگل، آموزش مهارت های مراقبه و تمرینات تمرکز حواس و تمرین تنفس سه دقیقه ای،ارائه جدول زمان بندی شده جهت یادداشت افکار و ذهنیت فرد در مواقع تجارب جنسی مطلوب و خوشایند، تجارب ناخوشایند، بیزاری، درد و انقباض در عضلات بدن، آموزش لذت بردن از یکدیگر . جلسه سوم اجرای ابعاد هفتم، هشتم و نهم مدل GES ، مد نظر قرار دادن مشکلات و نگرانی های یادداشت شده مراجعین طول هفته های قبل ، مشاوره در جهت سازگاری ظاهری با تغييرات آناتومیک،کمک به حفظ رابطه کلامی و عاطفی با همسر و تاکید بر اهمیت معاشقه و عشق بازی زوجین، تشریح و بررسی الگوی تغییرات جنسی و مشکلات جسمی احتمالی پس از یائسگی و تمرکز بر هدف پنجگانه در کامش،شناسایی پنج اصل برای رابطه جنسی ، پذیرش مقاصد چندگانه از جانب طرفین، اجتناب از اهداف یک جانبه و غیر انعطاف پذیر و روشن کردن برنامه جنسی ، تشریح پوزیشن های مختلف نزدیکی و سبک های تحریک جنسی ،ترکیب سبک ها و ایجاد تنوع در رابطه. جلسه چهارم اجرای اجرای ابعاد دهم، یازدهم و دوازدهم مدل GES، مشاوره و آموزش درباره تفاوت های جسمی و روانی زن و مرد در هر یک از مراحل چرخه جنسی، آموزش مهارت های ارتباطی، آموزش مهارت‌های خلق و حفظ صمیمیت.
  • Recruitment centers

    #1
    Name of recruitment center - English: Comprehensive healthcare centers
    Name of recruitment center - Persian: مراکز بهداشتی درمانی جامع سلامت
    Full name of responsible person - English: Samira barjaste
    Full name of responsible person - Persian: سمیرا برجسته
    Street address - English: Kilometer 11 of Saro Road - Nazlo Campus - School of Nursing and Midwifery.
    Street address - Persian: كيلومتر11 جاده سرو - پرديس نازلو - دانشکده پرستاري و مامايي
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 15335-57561
    Phone: +98 914 715 5545
    Fax:
    Email: Samira_barjaste_70@yahoo.com
    Web page address:
    Name of recruitment center - English: Comprehensive Healthcare Center No 6
    Name of recruitment center - Persian: مرکز بهداشتی درمانی جامع سلامت شماره 6
    Full name of responsible person - English: Samira Barjaste
    Full name of responsible person - Persian: سمیرا برجسته
    Street address - English: Healthcare Center No 6, in front of Urmia Guest House, Kashani St.,
    Street address - Persian: خیابان كاشانی، روبروی مهمانسرای اروميه، مرکز بهداشت شماره 6
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5715799313
    Phone: +98 44 3344 6085
    Fax:
    Email: Samira_barjaste_70@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Sahih Health Center
    Name of recruitment center - Persian: مرکز بهداشت صحیه
    Full name of responsible person - English: Leila Ali Aghdami
    Full name of responsible person - Persian: لیلا علی اقدمی
    Street address - English: Sahih Health Center, Delgosha Ave., Baath 3 St. (Ataei)
    Street address - Persian: خیابان بعثت 3 (عطایی)، کوی دلگشا، مرکز بهداشت صحیه
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5715799313
    Phone: +98 44 3223 6060
    Fax:
    Email: leila_aghdami@yahoo.com
    Web page address:
    Name of recruitment center - English: Comprehensive Healthcare Center No 16
    Name of recruitment center - Persian: مرکز بهداشتی درمانی جامع سلامت شماره ۱۶
    Full name of responsible person - English: Leila Ali Aghdami
    Full name of responsible person - Persian: لیلا علی اقدمی
    Street address - English: Comprehensive Healthcare Center No 16,Opposite the egg park ,Isar St
    Street address - Persian: خیابان ایثار، روبه روی پارک تخم مرغی؛ مرکز بهداشت شماره ۱۶
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5716138636
    Phone: +98 44 3383 2223
    Fax:
    Email: leila_aghdami@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Comprehensive Healthcare Center No 17
    Name of recruitment center - Persian: مرکز بهداشتی درمانی جامع سلامت شماره ۱۷
    Full name of responsible person - English: leila ali aghdami
    Full name of responsible person - Persian: لیلا علی اقدمی
    Street address - English: Comprehensive Healthcare Center No 17, Nobovat Boulevard, Alborz St
    Street address - Persian: خیابان البرز، بلوار نبوت، مرکز بهداشت شماره ۱۷
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5719749374
    Phone: +98 44 3338 5113
    Fax:
    Email: leila_aghdami@yahoo.com
    Web page address:
    #4
    Name of recruitment center - English: Comprehensive Healthcare Center No 13
    Name of recruitment center - Persian: مرکز بهداشتی درمانی جامع سلامت شماره ۱۳
    Full name of responsible person - English: leila ali aghdami
    Full name of responsible person - Persian: لیلا علی اقدمی
    Street address - English: Comprehensive Healthcare Center No 13, Imam Reza St, Azadegan Boulevard
    Street address - Persian: بلوار آزادگان، خیابان امام رضا، مرکز بهداشت شماره ۱۳
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5715864543
    Phone: +98 44 3367 0045
    Fax:
    Email: leila_aghdami@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mehdi Rajab Nia
    Full name of responsible person - Persian: مهدی رجب نیا
    Street address - English: Ganj Afrooz St.,Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Babol, Iran
    Street address - Persian: خیابان گنج افروز، معاونت پژوهشی دانشگاه علوم پزشکی بابل، دانشگاه علوم پزشکی بابل، بابل، ایران.
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4717647745
    Phone: +98 11 3219 4720
    Fax:
    Email: Ramazan69@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Mehdi Rajab Nia
    Full name of responsible person - Persian: دکتر مهدی رجب نیا
    Street address - English: Research Vice President, Babol University of Medical Sciences,University of Medical Sciences, Ganj Afrooz Ave.
    Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل، معاون پژوهشی دانشگاه
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4717647745
    Phone: +98 11 3219 4720
    Fax:
    Email: Ramazan69@yahoo.com
    Web page address: https://isid.research.ac.ir/Mehdi_Rajabnia
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nasiri Amiri
    Full name of responsible person - Persian: فاطمه نصیری امیری
    Position - English: University associate professor
    Position - Persian: دانشیار دانشگاه
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St.,
    Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل، دانشکده پزشکی، دپارتمان مامایی،
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4717647745
    Phone: +98 11 3219 0597
    Mobile: +98 911 112 2081
    Fax:
    Email: nasiri_fa@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fatemeh Nasiri Amiri
    Full name of responsible person - Persian: فاطمه نصیری امیری
    Position - English: University associate professor
    Position - Persian: دانشیار دانشگاه
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Ave.,
    Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل، دانشکده پزشکی، دپارتمان مامایی،
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4717647745
    Phone: +98 11 3219 0597
    Mobile: +98 911 112 2081
    Fax:
    Email: nasiri_fa@yahoo.com
    Web page address:

Protocol summary

Study aim
Comparison of effectiveness sex counseling based on the GES and PLISSIT models on the sexual problems of menopausal women
Design
A controlled clinical trial with a control group, with parallel groups, double blind, randomized, on 108 postmenopausal women, block randomization method was used for randomization.
Settings and conduct
The list of all women aged 45 to 60 in the selected Urmia health center has been prepared and each of them will be contacted by phone, and if they are satisfied in visiting the relevant health care centers, the women will complete the FSFI questionnaire. If the FSFI score is less than 28, they will be included in the study after obtaining written informed consent. Then they completed Larson's sexual satisfaction instruments, women's sexual quality of life (SQOL-F), sexual intimacy, and then they were randomly assigned to groups A, B, and C.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women in age range between 45 and 60 years; Being married; Complete cessation of menstruation in the last 12 months without the use of drugs or surgery; Literacy of reading and writing; Being monogamy; Having a stable sexual relationship in the last 4 weeks; scoring less than 28 in the Female Sexual Function Index (FSFI); Exclusion Criteria: Addicted to drugs and alcohol; Participating in any educational-counseling classes before or during the study; History of chronic physical and mental illness with self-report.
Intervention groups
Intervention group A will be treated based on the GES model. Intervention group B will be treated based on the PLISSIT model individually. The control group does not receive any counseling intervention and finally, after the end of the intervention, in order to comply with ethical considerations, the contents of the counseling will be provided to the group.
Main outcome variables
Sexual satisfaction, Quality of sexual life

General information

Reason for update
At the beginning of the study, two centers were selected as medical centers, and to speed up the study process, two medical centers were added to the list of diagnostic centers. A total of four centers were considered as study centers.
Acronym
IRCT registration information
IRCT registration number: IRCT20200122046228N4
Registration date: 2023-04-26, 1402/02/06
Registration timing: registered_while_recruiting

Last update: 2023-10-24, 1402/08/02
Update count: 1
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of sex counseling based on the GES (good enough sex) model and PLISSIT ( permission, limited information, specific suggestions, and intensive therapy) model on the sexual problems of menopausal women: A controlled trial study
Public title
Comparison of the effect of sex counseling based on the GES model and the PLISSIT model on the sexual problems of menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed written consent to participate in the study Complete cessation of menstruation in the last 12 months without the use of drugs or surgery Literacy of reading and writing Spouse's availability in the last 4 weeks and having sex Scoring less than 28 on the Female Sexual Function Index (FSFI) Having documents in health-care centers in Uromiyeh city Married women between 45 to 60 years old Being monogamy
Exclusion criteria:
Having known physical and mental illnesses according to self-report and constant use of medicine under the supervision of a doctor Taking drugs that affect sexual function (Sildenafil, antidepressants, antihistamines, diazepam, barbiturates, amphetamines, antihypertensive drugs, cocaine, etc.) Addiction or habitual consumption of alcohol by women Participating in other similar studies Occurrence of an unpleasant event during the 3 months before the study (death or serious illness of close relatives
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to one of the three study groups; (three groups A, B and C), the block randomization method with block size of 6 will be used. Then, according to the block randomization protocol (Randomization list using statistical program in R software environment version 3.6.1), the participants will be divided into one of the three groups: GES, PLISSIT, and the control group; They will be allocated with a ratio of 1:1:1, so that the researcher cannot predict which group the next person will be placed in the intervention group in each center. The participants are allocated to three groups of 36 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using a block of six.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Health Research Institute-Babol University of Medical Sciences
Street address
Vice Chancellor for Research, Babol University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.255

Health conditions studied

1

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

Primary outcomes

1

Description
Female sexual function
Timepoint
Before the start of the intervention and two months after the end of the intervention
Method of measurement
The 19-question scale of the Female Sexual Performance Index (FSFI) is used to evaluate sexual performance.

2

Description
Sexual satisfaction
Timepoint
Before the start of the intervention and two months after the end of the intervention
Method of measurement
Larson's 25-question sexual satisfaction scale will be used to evaluate sexual satisfaction.

Secondary outcomes

1

Description
Quality of sexual life
Timepoint
Before the start of the intervention and two months after the end of the intervention
Method of measurement
To evaluate the quality of sexual life, the 18-question questionnaire of the quality of sexual life of women (SQOL-F) will be used.

2

Description
Sexual intimacy
Timepoint
Before the start of the intervention and two months after the end of the intervention
Method of measurement
To evaluate sexual intimacy, the 30-question sexual intimacy scale will be used.

Intervention groups

1

Description
Intervention first group: in this group, women will receive sexual counseling in 4 sessions, 60 minutes, once a week, based on the concepts of the GES treatment model in a group (maximum 8-10 people). The first session of implementing the first three dimensions of the GES model and explaining the importance of sexual activity, teaching the definition of satisfaction and sexual performance and the factors affecting it, explaining the 4 stages of the sexual response cycle with an emphasis on the importance of knowing the sexual "desire" cycle, explaining the effect of menopause on sexual performance and its mechanism, encouraging the participants to write down their needs and expectations from sex, correcting misconceptions and superstitions about sex and creating an optimistic attitude. GES model, teaching healthy eating and performing Kegel exercises, teaching meditation skills and concentration exercises and three-minute breathing exercises, providing a time table to note down one's thoughts and mentality during pleasant and desirable sexual experiences, unpleasant experiences, dislike, Pain and contraction in body muscles, learning to enjoy each other. The third session of implementing the 7th, 8th and 9th dimensions of the GES model, taking into consideration the problems and concerns noted by the clients during the previous weeks, counseling for the appearance of adaptation to anatomical changes, helping to maintain the verbal and emotional relationship with the spouse and emphasizing the importance Flirting and making love of couples, explaining and examining the pattern of sexual changes and possible physical problems after menopause and focusing on the five goals in Kamesh, identifying the five principles for sexual relations, accepting multiple goals from the parties, avoiding one-sided and inflexible goals. and clarifying the sexual program, describing different positions of intimacy and sexual stimulation styles, combining styles and creating diversity in the relationship. The fourth session of the implementation of the 10th, 11th and 12th dimensions of the GES model, counseling and training about the physical and psychological differences between men and women in each of the stages of the sexual cycle, communication skills training, creation skills training and maintaining intimacy.
Category
Treatment - Other

2

Description
The second intervention group: In this group, women will receive sexual counseling during 4 sessions, 60 minutes, once a week based on the PLISSIT sexual counseling-therapy model, which includes permission, limited information, specific suggestions, and focused treatment. First step: permission; It means that the client should talk freely about his concerns in the sexual field. Also, at this stage, many sexual behaviors without problems that the patient has previously experienced are allowed to speak. Second stage: limited information; The therapist gives limited information about the patient's concerns. Third stage: exclusive offers; The patient is given specific suggestions to enable him to manage his sexual problems. Fourth stage: focused treatment; Psycho-sexual treatment is performed by the researcher and psychiatrist of the team. In order to prevent samples from falling and respond to their treatment problems, the researcher will be in regular contact with women between visits. Interventions will be free for participants.
Category
Treatment - Other

3

Description
Control group: The control group does not receive any intervention, and they will be under routine care according to the integrated care of menopausal women, and finally, after the end of the intervention and evaluations, due to ethical considerations, the contents of the consultation will be provided to the control group in the form of a compact CD file.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Healthcare Center No 6
Full name of responsible person
Samira Barjaste
Street address
Healthcare Center No 6, in front of Urmia Guest House, Kashani St.,
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3344 6085
Fax
Email
Samira_barjaste_70@yahoo.com

2

Recruitment center
Name of recruitment center
Comprehensive Healthcare Center No 16
Full name of responsible person
Leila Ali Aghdami
Street address
Comprehensive Healthcare Center No 16,Opposite the egg park ,Isar St
City
Urmia
Province
West Azarbaijan
Postal code
5716138636
Phone
+98 44 3383 2223
Email
leila_aghdami@yahoo.com

3

Recruitment center
Name of recruitment center
Comprehensive Healthcare Center No 17
Full name of responsible person
leila ali aghdami
Street address
Comprehensive Healthcare Center No 17, Nobovat Boulevard, Alborz St
City
Urmia
Province
West Azarbaijan
Postal code
5719749374
Phone
+98 44 3338 5113
Email
leila_aghdami@yahoo.com

4

Recruitment center
Name of recruitment center
Comprehensive Healthcare Center No 13
Full name of responsible person
leila ali aghdami
Street address
Comprehensive Healthcare Center No 13, Imam Reza St, Azadegan Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5715864543
Phone
+98 44 3367 0045
Email
leila_aghdami@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajab Nia
Street address
Research Vice President, Babol University of Medical Sciences,University of Medical Sciences, Ganj Afrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
Ramazan69@yahoo.com
Web page address
https://isid.research.ac.ir/Mehdi_Rajabnia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
University associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Ave.,
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz St., Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Nasiri- Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
nasiri_fa@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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