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The effect of yoga on women’s premenstrual syndrome

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History
# Registration date Revision Id
3 2018-10-04, 1397/07/12 76783
2 2015-03-15, 1393/12/24 7039
1
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  • Protocol summary

    Premenstrual syndrome (PMS) consists of regular and repetitive mental and physical symptoms that influences individual’s life. Regarding the side-effects of current medication, there are other approaches to control premenstrual symptoms and yoga is one of them. This randomized clinical trial study will be carried out on 62 subjects of woman who are recognized to have PMS by filling Premenstrual Symptoms Screening Tool (PSST) in two consecutive months. The subjects will allocate into intervention (yoga) and control group using block randomization method. The yoga group will do exercise the designed protocol of yoga with educater for PMS for 10 weeks of three 60-minute sessions for each week. The control group will not have any intervention. At the end of the tenth week, PSST will be filled again for each group and yoga book will be given to control group at the end of the study. The data will be analyzed by chi-square, independent t-test, paired t-test and analysis of covariance will be used for adjusting the confounding variables
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    سندرم پيش از قاعدگي (Premenstrual syndrome, PMS) شامل علائم منظم رواني و بدني تكراري مي باشد كه زندگي افراد را تحت تاثير قرار مي دهد. با توجه به عوارض دارو درمانی رایج، رهیافت های دیگر جهت کنترل علائم پیش از قاعدگی مطرح شده اند که یوگا یکی از آنها می باشد. این کارآزمایی بالینی بر روی 62 نفر از زنان که با پر کردن پرسشنامه PSST (Premenstrual Symptoms Screening Tool) در طی دو ماه متوالی، مبتلا به PMS تشخیص داده شده و مایل به شرکت در مطالعه باشند، انجام خواهد گرفت. نمونه ها با بلوک بندی به دو گروه مداخله (یوگا) و کنترل تخصیص خواهند یافت. گروه یوگا بمدت 10 هفته، هفته ای سه جلسه 60 دقیقه ای با هدایت مربی ، پروتکل یوگای طراحی شده برای PMS را تمرین خواهند نمود و گروه کنترل هیچ مداخله ای دریافت نخواهد کرد. در پایان هفته دهم پرسشنامه PSST مجددا برای هر دو گروه پر خواهند شد در پایان مطالعه به گروه کنترل کتاب یوگا تقدیم خواهد شد داده ها با آزمون کای دو، t مستقل، t زوجی وبرای گروه کنترل متغیرهای مخدوشگر از تحلیل کوواریانس استفاده خواهد شد.
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    1. The effect of yoga on premenstrual syndrome 2. The effect of yoga on sleep quality in women with premenstrual syndromeyoga on premenstrual syndrome 3.Yoga effect on anxiety in women with premenstrual syndrome 4.Yoga effect on depression and Blood Pressure in women with premenstrual syndrome 5. The effect of yoga on quality of life in women with premenstrual syndrome
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    1. تاثیر یوگا بر سندرم پیش از قاعدگی 2. تاثیر یوگا بر کیفیت خواب در زنان مبتلا سندرم پیش از قاعدگی 3. تاثیر یوگا بر اضطراب در زنان مبتلا سندرم پیش از قاعدگی 4. تاثیر یوگا بر افسردگی و فشارخون در زنان مبتلا سندرم پیش از قاعدگی 5. تاثیر یوگا بر کیفیت زندگی در زنان مبتلا سندرم پیش از قاعدگی
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    This is a double-blind, randomized controlled trial. Allotment in the yoga and control group will be done randomly in blocks 4 and 6 with an assignment ratio of 1 to 1. The sample size will be 62, which will be selected in each group of 31
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    این مطالعه یک کارآزمایی بالینی تصادفی شاهددار دو سوکور بود. تخصیص در گروه یوگا و شاهد به صورت تصادفی در بلوک های 4 و 6 تایی با نسبت تخصیص 1 به 1 انجام گرفت. حجم نمونه 62 نفر بود که در هر گروه 31 انتخاب خواهند گردید.
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    In this double-blind randomized clinical trial, among women referring At the private clinics of Tabriz women and delivery, those who were admitted to study with their desire to ask for a PSN PSK screening questionnaire for one month, and asked those who were diagnosed with PSAs with premenstrual syndrome, after obtaining informed consent, 61 Persons selected in a class and randomly assigned 4 and 6 blocked blocks to 31 yoga groups and 31 control group. Yoga moves for 10 weeks and each week in 3 60-minute sessions. Finally, the data on the variables of mood, behavior, physical and pms effects on the life of the questionnaires were analyzed using covariance analysis.
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    در این کار آزمایی بالینی تصادفی شاهددار دو سوکور، از بین زنان مراجعه کننده به مطبهای خصوصی زنان و زایمان تبریز، افراد حائز شرایط ورود به مطالعه با تمایل خود به مدت1 ماه پرسشنامه غربالگری علائم پیش از قاعدگیPSST را پرخواهند نمودند و از بین افرادیکه توسطPSST مبتلا به سندرم پیش از قاعدگی تشخیص داده شدند بعد از کسب رضایت آگاهانه ، 61 نفربطور طبقه ای انتخاب شده و بطور تصادفی با بلوک بندی 4 و 6 تایی به دو گروه یوگا 31 نفر وگروه کنترل 31 نفر تخصیص خواهند یافتند. حرکات یوگا به مدت 10 هفته و هر هفته در 3 جلسه 60 دقیقه ای انجام خواهد گرفت. در نهایت داده های متغیرهای خلقی، رفتاری، جسمی و تاثیر pms بر زندگی بدست آمده از پرسشنامه ها با استفاده از تحلیل کوواریانس مورد تجزیه و تحلیل قرار گرفت.
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    1. Women aged 18 to 45 2. Having a regular menstrual period 3.Catching PMS
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    1. زنان سنین 18 الی 45 سالگی 2. داشتن سابقه عادت ماهیانه منظم 3. ابتلا به PMS
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    Yoga exercises are conducted by a yoga instructor for a period of 10 weeks and each week for 3 sessions of 60 minutes. The samples will be applied and no intervention will be performed for the control group.
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    تمرینات یوگا توسط مربی یوگا طی یک دوره 10 هفته ای و هر هفته 3جلسه 60 دقیقه ای روی نمونه ها اعمال خواهد شد و برای گروه کنترل هیچ مداخله ای انجام نخواهد شد.
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    Yoga affects mood, behavior and physical symptoms in women with premenstrual syndrome.
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    یوگا بر نشانه خلقی، رفتاری و جسمی در زنان مبتلا به سندرم پیش از قاعدگی تاثیر دارد.

  • General information

    1
    1
    The effect of yoga on women’s premenstrual syndrome referring to private clinics in Tabriz
    The effect of yoga on women’s premenstrual syndrome
    تاثير يوگا بر سندرم پیش از قاعدگی در زنان مراجعه کننده به مطبهای خصوصی متخصصین زنان تبریز
    تاثير يوگا بر سندرم پیش از قاعدگی در زنان
    Inclusion criteria: age range of 20 till 45 years old
    Having regular history of menstruation
    Suffering from PMS according to the results of PSST questionnaire in two periods before intervention
    No consumption of effective medication on premenstrual syndrome and anti-pregnancy drugs three months before entering the study
    No history of depression based on the patients’ self representation
    No history of diseases related to genital organs based on the patients’ own representation
    No consumption of herbal drugs effective for premenstrual syndrome during last three months
    No consumption of alcohol, cigars and other impermissible materials based on the patients’ own representation
    No history of joints diseases and arthritis based on the patients’ own representation
    No history of surgery in body organs preventing individual from doing yoga practices
    No athletes; No consumption of caffeine; Tendency to participate in the research
    محدود سنی 20 الی 45 سالگی
    داشتن سابقه عادت ماهیانه منظم
    ابتلا به PMS طبق نتیجه بدست آمده از پرسشنامه PSST در دو سیکل قبل از مداخله
    عدم مصرف داروهاي موثر بر سندرم پيش از قاعدگي و قرص هاي ضد باروري سه ماه قبل از ورود به مطالعه
    عدم ابتلا به افسردگی بنا به اظهار بیمار
    عدم ابتلا به بيماري هاي دستگاه ژنیتال بنا به اظهار بیمار، عدم مصرف گیاهان دارویی تاثیر گذار بر PMS مانند روغن گل مغربی(بلک کوهوش) در سه ماه گذشته
    عدم مصرف الکل، سيگار، قلیان یا مواد غیرمجاز بنا به اظهار بیمار
    عدم ابتلا به بيماري هاي مفصلی و آرتریت روماتوئید بنا به اظهار بیمار
    عدم داشتن سابقه جراحی در اعضایی که مانع از انجام حرکات یوگا بشوند
    افراد غیر ورزشکار
    عدم مصرف کافئین
    تمایل به شرکت در مطالعه
    No tendency to remain in the study
    Having a history of yoga practices
    Occurrence of any influential incidence to the study trend, occurrence of stressful incidents like the death of close relatives during last 6 months
    عدم تمایل به ادامه حضور در مطالعه
    سابقه انجام تمرینات یوگا
    بروز هر حادثه ای تاثیر گذار بر مطالعه، وقوع حوادث استرس زا همانند مرگ نزديكان در 6 ماه اخیر
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    ندارد
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    Allocations in yoga and control groups will be done randomly in blocks 4 and 6 with a 5: 5 assignment ratio. In order to hide the allocation of opaque envelopes, which will be numbered sequentially. These packs are already prepared by the non-involved researcher in the data collection and the first envelope will be given to the first person with the inclusion criteria and will continue to complete the sample volume.
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    تخصیص در گروه یوگا و کنترل به صورت تصادفی در بلوک های 4 و 6 تایی با نسبت تخصیص 5:5 انجام خواهد گرفت. به منظور پنهان سازی تخصیص از پاکتهای دربسته مات که به ترتیب شماره گذاری خواهند شد استفاده خواهد شد. این پاکتها قبلا توسط پژوهشگر غیر درگیر در جمع آوری داده ها آماده و اولین پاکت به اولین فرد دارای معیارهای ورود به مطالعه داده خواهد شد و تا تکمیل حجم نمونه مورد نظر ادامه خواهد یافت.
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    This study was an interventional study of double-blind randomized controlled clinical trial, in which the data collector and analyzer were blind.
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    این مطالعه از نوع مطالعه مداخله ای کارآزمایی بالینی تصادفی شاهددار دو سوکور بود بطوریکه جمع آوری کننده و تجزیه و تحلیل کننده داده ها کور بودند.

  • Ethics committees

    #1
    93184
    IRCT201501216582N9

  • Health conditions studied

    #1
    Premenstrual syndrome
    Depression
    سندرم پیش از قاعدگی
    افسردگی

  • Primary outcomes

    #1
    the emotional symptoms-behavioral symptoms -physical symptoms- effect of PMS on life
    Symptoms of premenstrual syndrome
    نشانه های خلقی- نشانه های رفتاری- نشانه های جسمی- تاثیر PMS بر زندگی
    نشانه های سندرم پیش از قاعدگی
    befor intervention and ten weeks after the intervention
    Before intervention and 10 weeks after intervention
    psst questionary
    PSST Questionnaire
    پرسشنامه psst
    پرسشنامه PSST

  • Secondary outcomes

    #1
    The effect of yoga on qualiy of sleep women’s premenstrual syndrome referring to private clinics in Tabriz
    The Effect of Yoga on Quality of Sleep of Women with Premenstrual Syndrome
    تاثیر یوگا بر کیفیت خواب زنان مبتلا به سندرم پیش از قاعدگی مراجعه کننده به مطبهای خصوصی متخصصین زنان تبریز
    تاثیر یوگا بر کیفیت خواب زنان مبتلا به سندرم پیش از قاعدگی
    befor intervention and ten weeks after the intervention
    Before intervention and 10 weeks after intervention
    psst questionary
    PSST Questionnaire
    پرسشنامه psst
    پرسشنامه PSST
    #2
    Added at 2016-10-11: Quality of sleep questionnaire
    Added at 2016-10-11: Quality of Sleep Questionnaire
    #3
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    The Effect of Yoga on Depression and Blood Pressure of Women with Premenstrual Syndrome
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    تاثیر یوگا بر افسردگی و فشارخون زنان مبتلا به سندرم پیش از قاعدگی
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    Before intervention and 10 weeks after intervention
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    قبل از شروع مداخله و 10 هفته بعد از شروع مداخله
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    Beck Depression Questionnaire
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    پرسشنامه افسردگی بک
    #4
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    The Effect of Yoga on Anxiety and Vital Signs of Women with Premenstrual Syndrome
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    تاثیر یوگا بر اضطراب زنان مبتلا به سندرم پیش از قاعدگی
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    Before Intervention and 10 Weeks After Intervention
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    قبل از شروع مداخله و 10 هفته بعد از شروع مداخله
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    Hamilton Anxiety Rating Scale
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    پرسشنامه اضطراب هامیلتون
    #5
    empty
    The Effect of Yoga on Quality of Life of Women with Premenstrual Syndrome
    empty
    تاثیر یوگا بر کیفیت زندگی زنان مبتلا به سندرم پیش از قاعدگی
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    Before Intervention and 10 Weeks After Intervention
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    قبل از شروع مداخله و 10 هفته بعد از شروع مداخله
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    Quality of Life SF36 Questionnaire
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    پرسشنامه کیفیت زندگی SF36

  • Intervention groups

    #1
    Other
    Treatment - Other
    The yoga group will do exercise the designed protocol of yoga with educater for PMS for 10 weeks of three 60-minute sessions for each week.
    The yoga group will exercise the designed movements under supervision of the yoga coach for 10 weeks in three sessions and each session for 60-minute every week.
    #2
    Treatment - Drugs
    Treatment - Other
    The control group will not have any intervention
    The control group will not receive intervention.
    گروه کنترل هیچ مداخله ای دریافت نخواهد کرد
    گروه کنترل هیچ مداخله ای دریافت نخواهد کرد.

  • Recruitment centers

    #1
    Name of recruitment center - English: tabriz university of medical sinences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: mahin kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Street address - English:
    Street address - Persian:
    City - English: tabriz
    City - Persian: تبریز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Tabriz University of Medical Scinences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: mahin kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Street address - English: Golghasht st.
    Street address - Persian: خیابان گلگشت
    City - English: tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 51767-63663
    Phone: +98 41 3445 7624
    Fax: +98 41 3445 7624
    Email: KAMALIFARDM@tbzmed.ac.ir
    Web page address: https://www.tbzmed.ac.ir/

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tabriz University of Medical Sinences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Street address - English: Faculty of Nursing and Midwifery
    Street address - Persian: دانشکده پرستاری مامایی
    City - English: Tabriz
    City - Persian: تبریز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tabriz University of Medical Sinences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Street address - English: Faculty of Nursing and Midwifery
    Street address - Persian: دانشکده پرستاری مامایی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 51767-63663
    Phone: +98 41 3445 7624
    Fax: +98 41 3445 7624
    Email: KAMALIFARDM@tbzmed.ac.ir
    Web page address: https://www.tbzmed.ac.ir/
    N/A
    Yes
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    Public
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    Domestic
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    Persons
    Deputy of Scientific and Research of Nursing and Midwifery Faculty
    معاونت علمی و پژوهشی دانشکده پرستاری و مامایی
    Tabriz University of Medical Sinences
    Tabriz University of Medical Sinence

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Position - English: Professor
    Position - Persian: هیئت علمی
    Latest degree: master
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golghasht Ave.
    Street address - Persian: خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 51767-63663
    Phone: +98 41 3445 7624
    Mobile: +98 914 405 8245
    Fax: +98 41 3445 7624
    Email: kamalifardm@tbzmed.ac.ir
    Web page address: http://tbzmed.ac.ir/

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Academic member of Tabriz Medical scienses
    Name of organization / entity - Persian: عضو هیت علمی دانشگاه علوم پزشکی تبریز
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Position - English: MS
    Position - Persian: کارشناسی ارشد
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing and Midwifery
    Street address - Persian: دانشکده پرستاری و مامایی
    City - English: Tabriz
    City - Persian: تبریز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 41 3479 6770
    Mobile: +98 914 314 6763
    Fax:
    Email: kamalifardm@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Position - English: MS
    Position - Persian: کارشناسی ارشد
    Latest degree: master
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing and Midwifery
    Street address - Persian: دانشکده پرستاری و مامایی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 51767-63663
    Phone: +98 41 3479 6770
    Mobile: +98 914 314 6763
    Fax: +98 41 3479 6770
    Email: kamalifardm@tbzmed.ac.ir
    Web page address: https://www.tbzmed.ac.ir/

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahin Kamalifard
    Full name of responsible person - Persian: مهین کمالی فرد
    Position - English: Professor
    Position - Persian: هیدت علمی
    Latest degree: master
    Area of specialty/work: 1
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Golghasht Ave.
    Street address - Persian: خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 51767-63663
    Phone: +98 41 3445 7624
    Mobile: +98 914 405 8245
    Fax: +98 41 3445 7624
    Email: kamalifardm@tbzmed.ac.ir
    Web page address: https://www.tbzmed.ac.ir/

  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    Information on the main outcome
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    اطلاعات مربوط به پیامد اصلی
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    2016
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    1395
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    People working in academic institutions
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    محققین شاغل در موسسات دانشگاهی و علمی
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    To check the results and the relationship of data
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    برای بررسی نتایج و ارتباط داده ها
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    00989144058245 Ghafoureh ghaffarilaleh ghafoureh@gmail.com
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    غفوره غفاری لاله 00989144058245 ghafoureh@gmail.com
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    Email or mobile will be sent within two weeks.
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    در صورت تماس با ایمیل یا موبایل در عرض دو هفته ارسال میشود.
    empty
    I would share my scientific information.
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    تمایل به اشتراک گذاری اطلاعات علمی دارم

Protocol summary

Study aim
1. The effect of yoga on premenstrual syndrome 2. The effect of yoga on sleep quality in women with premenstrual syndromeyoga on premenstrual syndrome 3.Yoga effect on anxiety in women with premenstrual syndrome 4.Yoga effect on depression and Blood Pressure in women with premenstrual syndrome 5. The effect of yoga on quality of life in women with premenstrual syndrome
Design
This is a double-blind, randomized controlled trial. Allotment in the yoga and control group will be done randomly in blocks 4 and 6 with an assignment ratio of 1 to 1. The sample size will be 62, which will be selected in each group of 31
Settings and conduct
In this double-blind randomized clinical trial, among women referring At the private clinics of Tabriz women and delivery, those who were admitted to study with their desire to ask for a PSN PSK screening questionnaire for one month, and asked those who were diagnosed with PSAs with premenstrual syndrome, after obtaining informed consent, 61 Persons selected in a class and randomly assigned 4 and 6 blocked blocks to 31 yoga groups and 31 control group. Yoga moves for 10 weeks and each week in 3 60-minute sessions. Finally, the data on the variables of mood, behavior, physical and pms effects on the life of the questionnaires were analyzed using covariance analysis.
Participants/Inclusion and exclusion criteria
1. Women aged 18 to 45 2. Having a regular menstrual period 3.Catching PMS
Intervention groups
Yoga exercises are conducted by a yoga instructor for a period of 10 weeks and each week for 3 sessions of 60 minutes. The samples will be applied and no intervention will be performed for the control group.
Main outcome variables
Yoga affects mood, behavior and physical symptoms in women with premenstrual syndrome.

General information

Reason for update
Acronym
PMS
IRCT registration information
IRCT registration number: IRCT201501216582N9
Registration date: 2015-03-15, 1393/12/24
Registration timing: prospective

Last update: 2019-01-26, 1397/11/06
Update count: 1
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences branch aras
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on women’s premenstrual syndrome
Public title
The effect of yoga on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: age range of 20 till 45 years old Having regular history of menstruation Suffering from PMS according to the results of PSST questionnaire in two periods before intervention No consumption of effective medication on premenstrual syndrome and anti-pregnancy drugs three months before entering the study No history of depression based on the patients’ self representation No history of diseases related to genital organs based on the patients’ own representation No consumption of herbal drugs effective for premenstrual syndrome during last three months No consumption of alcohol, cigars and other impermissible materials based on the patients’ own representation No history of joints diseases and arthritis based on the patients’ own representation No history of surgery in body organs preventing individual from doing yoga practices No athletes; No consumption of caffeine; Tendency to participate in the research
Exclusion criteria:
No tendency to remain in the study Having a history of yoga practices Occurrence of any influential incidence to the study trend, occurrence of stressful incidents like the death of close relatives during last 6 months
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Allocations in yoga and control groups will be done randomly in blocks 4 and 6 with a 5: 5 assignment ratio. In order to hide the allocation of opaque envelopes, which will be numbered sequentially. These packs are already prepared by the non-involved researcher in the data collection and the first envelope will be given to the first person with the inclusion criteria and will continue to complete the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was an interventional study of double-blind randomized controlled clinical trial, in which the data collector and analyzer were blind.
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of tabriz university of medical sinences
Street address
golgasht st.
City
tabriz
Province
East Azarbaijan
Postal code
51767-63663
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
IRCT201501216582N9

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Symptoms of premenstrual syndrome
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
PSST Questionnaire

Secondary outcomes

1

Description
The Effect of Yoga on Quality of Sleep of Women with Premenstrual Syndrome
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
PSST Questionnaire

2

Description
Added at 2016-10-11: quality of sleep
Timepoint
Added at 2016-10-11: 2015/4/29 to 2015/7/11
Method of measurement
Added at 2016-10-11: Quality of Sleep Questionnaire

3

Description
The Effect of Yoga on Depression and Blood Pressure of Women with Premenstrual Syndrome
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
Beck Depression Questionnaire

4

Description
The Effect of Yoga on Anxiety and Vital Signs of Women with Premenstrual Syndrome
Timepoint
Before Intervention and 10 Weeks After Intervention
Method of measurement
Hamilton Anxiety Rating Scale

5

Description
The Effect of Yoga on Quality of Life of Women with Premenstrual Syndrome
Timepoint
Before Intervention and 10 Weeks After Intervention
Method of measurement
Quality of Life SF36 Questionnaire

Intervention groups

1

Description
The yoga group will exercise the designed movements under supervision of the yoga coach for 10 weeks in three sessions and each session for 60-minute every week.
Category
Treatment - Other

2

Description
The control group will not receive intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Scinences
Full name of responsible person
mahin kamalifard
Street address
Golghasht st.
City
tabriz
Province
East Azarbaijan
Postal code
51767-63663
Phone
+98 41 3445 7624
Fax
+98 41 3445 7624
Email
KAMALIFARDM@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sinences
Full name of responsible person
Mahin Kamalifard
Street address
Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
51767-63663
Phone
+98 41 3445 7624
Fax
+98 41 3445 7624
Email
KAMALIFARDM@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Deputy of Scientific and Research of Nursing and Midwifery Faculty
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sinence
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golghasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51767-63663
Phone
+98 41 3445 7624
Fax
+98 41 3445 7624
Email
kamalifardm@tbzmed.ac.ir
Web page address
http://tbzmed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
MS
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
51767-63663
Phone
+98 41 3479 6770
Fax
+98 41 3479 6770
Email
kamalifardm@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golghasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
51767-63663
Phone
+98 41 3445 7624
Fax
+98 41 3445 7624
Email
kamalifardm@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
2016
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
To check the results and the relationship of data
From where data/document is obtainable
00989144058245 Ghafoureh ghaffarilaleh ghafoureh@gmail.com
What processes are involved for a request to access data/document
Email or mobile will be sent within two weeks.
Comments
I would share my scientific information.
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