History
# Registration date Revision Id
2 2025-07-26, 1404/05/04 349775
1 2016-05-07, 1395/02/18 19928
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    This study has been conducted to investigate the effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women.Menopause women in Ahvaz are the population of the study in this Randomized Control Trial.The samples of the study are the women with eligibility criteria and willingness to participate in this study. Inclusion criteria include: natural or surgical menopause, between at least the first and at last the fifth years after the normal menstrual cycles’ stop, being married,Without any physical disability to do the techniques and This technique has not been used in the past six months. Exclusion criteria include: a self-report of concurrent or history of psychological disorders as well as taking antipsychotic medications, taking Hormone Replacement Therapy (HRT) or vagial estrogen, Fill out the questionnaire incompletely, occurrence of misadventure in the past six months,self-report of dependence on nicotine, alcohol, opioids and other psychotropic drugs and absences of more than two sessions and Unwillingness to participate in the study any more.This RCT is recruiting 60 women (30 participants in each of the control and the intervention groups) from east and west health centers of Ahvaz. For the intervention group(5 groups comprising 6 participants), mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions, according to MBSR protocol by Jon Kabat-Zinn in 2014. For the control group, three months after the intervention and at the end of three stages of evaluation, mindfulness training will be performed in 2 sessions, because of ethical considerations. All participants will complete Menopause Specific Quality of Life questionnaire before the intervention, immediately after the intervention and three months after the intervention completion.
    empty
    هدف از پژوهش حاضر بررسی تاثیر آموزش مبتنی بر ذهن آگاهی بر کیفیت زندگی مرتبط با سلامت و دیسترس جنسی زنان یائسه است. چجامعه پژوهش در این کارازمایی بالینی زنان یائسه شهر اهواز می باشند.نمونه پژوهش شامل زنانی از جامعه پژوهش است که واجد شرایط ورود و خروج بوده و تمایل به شرکت در این مطالعه دارند.معیارهای ورود شامل یائسگی طبیعی یا ناشی از جراحی،گروه سنی 47 تا 62 سال،در فاصله حداقل 1 سال و حداکثر 5 سال از قطع طبیعی قاعدگی،متاهل بودن،نداشتن محدودیت جسمی جهت انجام تکنیک ها،نداشتن سابقه قبلی استفاده از تکنیک ها طی 6 ماه گذشته می باشد.معیارهای خروج شامل بیماری های روانشناختی بر اساس اظهار نظر شخصی خود فرد،بروز پیشامدها و اتفاقات ناگوار طی 6 ماه اخیر،عدم استفاده از درمان های جایگزینی هورمونی یا استروژن واژینال طی 6 ماه گذشته،عدم پاسخ به تمامی سوالات پرسشنامه،اعتیاد به نیکوتین،الکل، مواد مخدر و سایر داروهای روان گردان بر اساس اظهار نظر شخصی خود فرد،مصرف داروهای آنتی سایکوتیک،بیش از 2 جلسه غیبت،عدم تمایل بیمار به ادامه شرکت در مداخله می باشد.حجم نمونه در این کارازمایی بالینی تصادفی برابر 60 نفر(30 نفر در گروه مداخله و 30 نفر در گروه کنترل) و از مراکز بهداشتی- درمانی شرق و غرب اهواز می باشد.گروه مداخله(6 گروه 5 نفره) تحت 8 جلسه آموزش ذهن آگاهی بر اساس پروتکل MBSR(جان کابات زین، 2014) بصورت هفتگی و به مدت 120دقیقه قرار خواهند گرفت.گروه کنترل پس از پایان پژوهش، جهت رعایت موازین اخلاقی طی 2 جلسه آموزش ذهن آگاهی بصورت فشرده قرار خواهند گرفت.هر دو گروه در زمان های قبل از مداخله،بلافاصله پس از اتمام مداخله و 3 ماه پس از اتمام مداخله توسط پرسشنامه کیفیت زندگی مرتبط با سلامت و مقیاس دیسترس جنسی زنان ارزیابی خواهند شد.
    empty
    empty
    This study aims to evaluate the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on sexual distress and health-related quality of life among postmenopausal women.
    empty
    هدف این مطالعه، بررسی اثربخشی برنامه کاهش استرس مبتنی بر ذهن‌آگاهی (MBSR) بر پریشانی جنسی و کیفیت زندگی مرتبط با سلامت در زنان یائسه می‌باشد.
    empty
    This is a randomized controlled trial (RCT) with a pre-test, post-test, and 3-month follow-up design.
    empty
    این مطالعه از نوع کارآزمایی بالینی تصادفی (RCT) با طراحی پیش‌آزمون، پس‌آزمون و پیگیری سه‌ماهه می‌باشد.
    empty
    The study will be conducted at health centers affiliated with Ahvaz Jundishapur University of Medical Sciences. Recruitment and intervention delivery will be carried out by trained facilitators under supervision.
    empty
    مطالعه در مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی جندی‌شاپور اهواز انجام خواهد شد. فرایند جذب شرکت‌کنندگان و اجرای مداخله توسط تسهیل‌گران آموزش‌دیده و تحت نظارت انجام می‌گیرد.
    empty
    Participants will be naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Inclusion criteria include: a score >11 on the FSDS-R questionnaire, being married, no physical limitations for mindfulness practice, and no similar interventions in the past 6 months. Exclusion criteria include: acute or chronic illness affecting menopausal symptoms, recent major life stressors, hormone therapy in the past 6 months, substance abuse, use of antipsychotics, or engagement in professional physical activity.
    empty
    شرکت‌کنندگان، زنان یائسه طبیعی در محدوده سنی ۴۷ تا ۶۲ سال هستند که بین ۱ تا ۵ سال از آخرین قاعدگی آن‌ها گذشته باشد. معیارهای ورود شامل: نمره بالاتر از ۱۱ در پرسشنامه FSDS-R، متأهل بودن، نداشتن محدودیت جسمی برای انجام تمرینات ذهن‌آگاهی، و عدم شرکت در مداخلات مشابه در شش ماه گذشته است. معیارهای خروج شامل: ابتلا به بیماری‌های حاد یا مزمن مؤثر بر علائم یائسگی، تجربه استرس شدید در شش ماه گذشته، استفاده از درمان‌های هورمونی یا استروژن موضعی در شش ماه اخیر، سوءمصرف مواد، مصرف داروهای ضدروان‌پریشی، یا فعالیت بدنی حرفه‌ای می‌باشد.
    empty
    The intervention group will participate in eight weekly 90-minute sessions of MBSR training. The sessions include body scan, mindful breathing, yoga-based movements, and group discussion. The control group will receive no intervention during the study period.
    empty
    گروه مداخله در هشت جلسه ۹۰ دقیقه‌ای هفتگی آموزش کاهش استرس مبتنی بر ذهن‌آگاهی (MBSR) شرکت خواهد کرد. این جلسات شامل اسکن بدن، تنفس آگاهانه، حرکات مبتنی بر یوگا و بحث گروهی می‌باشد. گروه کنترل در طول مدت مطالعه هیچ‌گونه مداخله‌ای دریافت نخواهد کرد.
    empty
    Primary outcomes include changes in sexual distress (measured by FSDS-R) and health-related quality of life (measured by SF-36) from baseline to post-intervention and 3-month follow-up.
    empty
    متغیرهای اصلی شامل تغییرات در پریشانی جنسی (با استفاده از پرسشنامه FSDS-R) و کیفیت زندگی مرتبط با سلامت (با استفاده از پرسشنامه SF-36) از زمان پیش‌آزمون تا پس‌آزمون و پیگیری سه‌ماهه می‌باشد.
  • General information

    Not blinded
    Single blinded
    1
    Parallel
    Other
    empty
    60
    2015-12-31, 1394/10/10
    2016-01-30, 1394/11/10
    2015-12-31, 1394/10/10
    2016-06-30, 1395/04/10
    empty
    2019-07-01, 1398/04/10
    empty
    2019-12-01, 1398/09/10
    empty
    2019-12-01, 1398/09/10
    empty
    Dear Respected Director, At the end of 2015, due to my marriage, relocation from Ahvaz, subsequent pregnancy, the passing of my mother, and later my father's heart disease and surgery (along with the mild depression that naturally followed), I was unable to return to Ahvaz. After my circumstances and emotional state improved, I was finally able to resume my work and sampling in Ahvaz in 2019. Thank you for your understanding.
    empty
    با سلام و خسته نباشید خدمت مدیر محترم در انتهای سال 94 به علت ازدواج و خارج شدن از اهواز و بارداری متعاقب و فوت همزمان مادر و متعاقبا بیمایر قلبی پدرم و جراحی قلب ایشان(و یقینا افسردگی مختصر ایجاد شده) توانایی بازگشت به اهواز برایم مقدور نشد. پس از بهبود شرایط و روحیه ام، مجدد در سال 98 موفق به بازگشت به اهواز و و نمونه گیری و ادامه کارم شدم. سپاسگزارم.
    Eligible participants were naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Additional inclusion criteria were: a score >11 on the FSDS-R questionnaire during pretest screening, being married, having no physical limitations for performing mindfulness exercises, and no prior participation in similar interventions within the previous six months.
    شرکت‌کنندگان واجد شرایط، زنان یائسه طبیعی در محدوده سنی ۴۷ تا ۶۲ سال بودند که بین ۱ تا ۵ سال از آخرین قاعدگی آن‌ها گذشته بود. سایر معیارهای ورود به مطالعه شامل موارد زیر بودند: کسب نمره‌ای بیش از ۱۱ در پرسشنامه پریشانی جنسی (FSDS-R) در مرحله غربالگری اولیه، متأهل بودن، نداشتن محدودیت جسمی برای انجام تمرینات ذهن‌آگاهی، و عدم مشارکت در مداخلات مشابه طی شش ماه گذشته.
    Exclusion criteria included: presence of acute or chronic diseases or conditions affecting menopausal symptoms (e.g., thyroid disorders, cognitive impairment), recent adverse life events (within six months), use of hormone replacement therapy or topical estrogens (within six months), alcohol or drug abuse, antipsychotic medication use, and professional physical activity. Participants who missed more than two sessions, experienced a major stressor during the intervention, or expressed unwillingness to continue were withdrawn from the study.
    معیارهای خروج از مطالعه شامل موارد زیر بودند: وجود بیماری‌های حاد یا مزمن یا شرایطی که بر علائم یائسگی تأثیر می‌گذارند (مانند اختلالات تیروئید، ناتوانی‌های شناختی)، تجربه رویدادهای ناخوشایند زندگی طی شش ماه گذشته، مصرف درمان جایگزینی هورمونی یا استروژن‌های موضعی در شش ماه اخیر، سوءمصرف الکل یا مواد مخدر، مصرف داروهای ضدروان‌پریشی، و فعالیت بدنی حرفه‌ای. همچنین، شرکت‌کنندگانی که بیش از دو جلسه را از دست دادند، در طول مداخله دچار استرس شدید شدند، یا تمایلی به ادامه همکاری نداشتند، از مطالعه خارج شدند.
    empty
    Participants were randomly assigned to either the intervention or control group using permuted block randomization with varying block sizes of 4, 6, and 8. Due to the nature of the intervention, blinding of participants and facilitators was not possible. However data analysts were blinded to group assignments.
    empty
    شرکت‌کنندگان به‌صورت تصادفی و با استفاده از روش تصادیسازی بلوکی متناوب با اندازه بلوک‌های متفاوت (۴، ۶ و ۸) به یکی از دو گروه مداخله یا کنترل تخصیص داده شدند. به دلیل ماهیت مداخله، امکان کورسازی شرکت‌کنندگان و تسهیل‌گران وجود نداشت، اما تحلیل‌گران داده نسبت به تخصیص گروهی شرکت‌کنندگان کور بودند.
    empty
    Data analysts were blinded to group assignments.
    empty
    تحلیل‌گران داده نسبت به تخصیص گروهی شرکت‌کنندگان کور بودند.
    empty
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: East Health Centers of Ahvaz
    Name of recruitment center - Persian: مرکز بهداشتی شرق اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: East Health Centers of Ahvaz
    Name of recruitment center - Persian: مرکز بهداشتی شرق اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61357-15794
    Phone: +98 61 3311 0000
    Fax:
    Email: eduaum@ajums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: West Health Centers of Ahvaz
    Name of recruitment center - Persian: مرکز بهداشتی غرب اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: West Health Centers of Ahvaz
    Name of recruitment center - Persian: مرکز بهداشتی غرب اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61357-15794
    Phone: +98 61 3311 0000
    Fax:
    Email: eduaum@ajums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Nader Saki
    Full name of responsible person - Persian: دکتر نادر صاکی
    Street address - English: Golestan Blvd, Ahvaz Jundishapur University of Medical Science
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Nader Saki
    Full name of responsible person - Persian: دکتر نادر صاکی
    Street address - English: Golestan Blvd, Ahvaz Jundishapur University of Medical Science
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135715794
    Phone: +98 61 3311 0000
    Fax:
    Email: eduaum@ajums.ac.ir
    Web page address:
    -
    MARC-9407
    empty
    Public
    empty
    Domestic
    empty
    Academic
    -
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Position - English: MSc. Student of Counseling in Midwifery
    Position - Persian: دانشجوی کارشناسی ارشد رشته مشاوره در مامایی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of Jundishapur University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: 00
    Mobile: +98 911 157 1204
    Fax: -
    Email: Yazdani_mw89@yahoo.comYazdani.m@ajums.ac.ir
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Position - English: Ph.D Student of Reproductive Health
    Position - Persian: دانشجوی دکترای بهداشت باروری
    Latest degree: master
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal AleAhmad, Nasr bridge
    Street address - Persian: جلال آل احمد، پل نصر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: 00
    Mobile: +98 911 157 1204
    Fax:
    Email: yazdani.mw89@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Mojgan Javadnoori
    Full name of responsible person - Persian: دکتر مژگان جوادنوری
    Position - English: PhD of Reproductive Health, Assistant Professor
    Position - Persian: دکتری بهداشت باروری، استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of Jundishpur University of Medical Science
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: 00
    Mobile: +98 916 308 2048
    Fax: -
    Email: mozhganjavadnoori@yahoo.com
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Dr. Mojgan Javadnoori
    Full name of responsible person - Persian: دکتر مژگان جوادنوری
    Position - English: PhD of Reproductive Health, Assistant Professor
    Position - Persian: دکتری بهداشت باروری، استاد
    Latest degree: phd
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of Jundishpur University of Medical Science
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: -
    Mobile: +98 916 308 2048
    Fax:
    Email: mozhganjavadnoori@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jundishapur University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Position - English: MSc. Student of Counseling in Midwifery
    Position - Persian: دانشجوی کارشناسی ارشد رشته مشاوره در مامایی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golestan Blvd, Golestane Enghelab Dormitory of Jundishapur University of Medical Science
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی جندی شاپور
    City - English: Ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: 00
    Mobile: +98 911 157 1204
    Fax:
    Email: Yazdani_mw89@yahoo.com
    Web page address: -
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Masoomeh Yazdani Aliabadi
    Full name of responsible person - Persian: معصومه یزدانی علی آبادی
    Position - English: Ph.D Student of Reproductive Health
    Position - Persian: دانشجوی دکترای بهداشت باروری
    Latest degree: master
    Area of specialty/work: 53
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Jalal AleAhmad, Nasr bridge
    Street address - Persian: بلوار گلستان، خوابگاه گلستان انقلاب دانشگاه علوم پزشکی جندی شاپور
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: 00
    Mobile: +98 911 157 1204
    Fax:
    Email: yazdani.mw89@gmail.com
    Web page address:
  • Sharing plan

    no
    no
    no
    no
    no
    no
    no
    empty
    Concerning about data privacy
    empty
    نگرانی از حریم خصوصی داده‌ها

Protocol summary

Study aim
This study aims to evaluate the effectiveness of a Mindfulness-Based Stress Reduction (MBSR) program on sexual distress and health-related quality of life among postmenopausal women.
Design
This is a randomized controlled trial (RCT) with a pre-test, post-test, and 3-month follow-up design.
Settings and conduct
The study will be conducted at health centers affiliated with Ahvaz Jundishapur University of Medical Sciences. Recruitment and intervention delivery will be carried out by trained facilitators under supervision.
Participants/Inclusion and exclusion criteria
Participants will be naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Inclusion criteria include: a score >11 on the FSDS-R questionnaire, being married, no physical limitations for mindfulness practice, and no similar interventions in the past 6 months. Exclusion criteria include: acute or chronic illness affecting menopausal symptoms, recent major life stressors, hormone therapy in the past 6 months, substance abuse, use of antipsychotics, or engagement in professional physical activity.
Intervention groups
The intervention group will participate in eight weekly 90-minute sessions of MBSR training. The sessions include body scan, mindful breathing, yoga-based movements, and group discussion. The control group will receive no intervention during the study period.
Main outcome variables
Primary outcomes include changes in sexual distress (measured by FSDS-R) and health-related quality of life (measured by SF-36) from baseline to post-intervention and 3-month follow-up.

General information

Reason for update
Dear Respected Director, At the end of 2015, due to my marriage, relocation from Ahvaz, subsequent pregnancy, the passing of my mother, and later my father's heart disease and surgery (along with the mild depression that naturally followed), I was unable to return to Ahvaz. After my circumstances and emotional state improved, I was finally able to resume my work and sampling in Ahvaz in 2019. Thank you for your understanding.
Acronym
IRCT registration information
IRCT registration number: IRCT2015121623344N2
Registration date: 2016-05-07, 1395/02/18
Registration timing: prospective

Last update: 2025-07-31, 1404/05/09
Update count: 1
Registration date
2016-05-07, 1395/02/18
Registrant information
Name
Masoomeh Yazdani Aliabadi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 911 157 1204
Email address
yazdani.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Jundishapur University of Medical Science
Expected recruitment start date
2016-01-30, 1394/11/10
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2019-12-01, 1398/09/10
Scientific title
The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
Public title
The effect of mindfulness-based training on health related quality of life and female sexual distress in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eligible participants were naturally postmenopausal women aged 47–62 years, with 1 to 5 years since their last menstrual period. Additional inclusion criteria were: a score >11 on the FSDS-R questionnaire during pretest screening, being married, having no physical limitations for performing mindfulness exercises, and no prior participation in similar interventions within the previous six months.
Exclusion criteria:
Exclusion criteria included: presence of acute or chronic diseases or conditions affecting menopausal symptoms (e.g., thyroid disorders, cognitive impairment), recent adverse life events (within six months), use of hormone replacement therapy or topical estrogens (within six months), alcohol or drug abuse, antipsychotic medication use, and professional physical activity. Participants who missed more than two sessions, experienced a major stressor during the intervention, or expressed unwillingness to continue were withdrawn from the study.
Age
From 47 years old to 62 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to either the intervention or control group using permuted block randomization with varying block sizes of 4, 6, and 8. Due to the nature of the intervention, blinding of participants and facilitators was not possible. However data analysts were blinded to group assignments.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analysts were blinded to group assignments.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394. 564

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause

Primary outcomes

1

Description
Health related quality of life
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Health related quality of life(SF36)

2

Description
Female sexual distress
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Female sexual distress scale(FSDS)

Secondary outcomes

1

Description
Physical functioning(PF)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 3 to 12 of SF36

2

Description
Role physical(RF)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 13 to 16 of SF36

3

Description
Role emotional(RE)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
Questions 17 to 19 of SF36

4

Description
Vitaity(VT)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 23, 27, 29 and 31 of SF36

5

Description
Mental health(MH)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 24, 25, 26, 28 and 30 of SF36

6

Description
Social functioning
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 20 and 32 of SF36

7

Description
Bodily pain(BP)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 21 and 22 of SF36

8

Description
General health(GH)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
questions 1, 33 and 36 of SF36

9

Description
The Physical Component of Summary(PCS)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
PF+RF+BP+GH dimensions of SF36 Questionnaire

10

Description
The Mental Component Summary(MCS)
Timepoint
Before the intervention, Immediately after the intervention, Three months after the intervention completion
Method of measurement
SF+RE+MH+VT dimentions of SF36 Questionnaire

Intervention groups

1

Description
Intervention group: According to MBSR protocol (Jon Kabat-Zinn, 2014) mindfulness training will be performed just once a week, in 120 minutes and during 8 sessions for each of 5 groups.
Category
Behavior

2

Description
Control group: Because of ethical considerations, mindfulness training will be performed in 2 sessions, three months after the intervention and at the end of three stages of evaluation.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
East Health Centers of Ahvaz
Full name of responsible person
Masoomeh Yazdani Aliabadi
Street address
Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir

2

Recruitment center
Name of recruitment center
West Health Centers of Ahvaz
Full name of responsible person
Masoomeh Yazdani Aliabadi
Street address
Golestan Blvd, Golestane Enghelab Dormitory of University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Nader Saki
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
eduaum@ajums.ac.ir
Grant name
Grant code / Reference number
MARC-9407
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Ahvaz Jundishapur 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
Tarbiat Modares University
Full name of responsible person
Masoomeh Yazdani Aliabadi
Position
Ph.D Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Jalal AleAhmad, Nasr bridge
City
Tehran
Province
Tehran
Postal code
-
Phone
00
Fax
Email
yazdani.mw89@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Mojgan Javadnoori
Position
PhD of Reproductive Health, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan Blvd, Golestane Enghelab Dormitory of Jundishpur University of Medical Science
City
Ahvaz
Province
Khouzestan
Postal code
-
Phone
-
Fax
Email
mozhganjavadnoori@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoomeh Yazdani Aliabadi
Position
Ph.D Student of Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Jalal AleAhmad, Nasr bridge
City
Tehran
Province
Tehran
Postal code
-
Phone
00
Fax
Email
yazdani.mw89@gmail.com
Web page address

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
Concerning about data privacy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Loading...