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The effect of Mindfulness Based Stress Reduction (MBSR) hope and spirituality well-being of women with breast cancer

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History
# Registration date Revision Id
2 2022-05-22, 1401/03/01 227818
1 2018-01-02, 1396/10/12 31781
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  • Protocol summary

    - Efficacy of mindfulness based stress reduction on depression, anxiety, stress, anger, spirituality well being and hope in women with breast cancer
    The effect of Mindfulness Based Stress Reduction (MBSR) on hope and spirituality well-being of women with breast cancer
    - تعیین اثر بخشی مداخله درمانی کاهش استرس براساس بهوشیاری (MBSR) بر روی افسردگی، اضطراب، استرس، خشم، بهزیستی معنوی و امیدواری زنان مبتلا به سرطان پستان
    اثر بخشی مداخله درمانی کاهش استرس براساس بهوشیاری (MBSR) بر امیدواری و بهزیستی معنوی زنان مبتلا به سرطان پستان
    The sample consists of 30 breast cancer patients who will be selected from among the respondents and then will be randomly assigned to two groups (15 in the experimental group: the group that will be trained in meditation exercise and 15 People for the control group).
    The sample of this study included 68 breast cancer patients selected from patients at Tabriz Hospitals and randomly allocated into two groups: MBSR group (n=34) and usual care, waitlist group (n=34).
    نمونه پژوهش حاضر شامل 30 بیمار مبتلا به سرطان پستان هستند که بصورت در دسترس از بین مراجعه کنندگان انتخاب خواهند شد وسپس به صورت تصادفی در دو گروه جایگزین خواهند شد (15 نفر در گروه آزمایش: گروهی که تحت آموزش مراقبه بهوشیاری قرار خواهند گرفت و 15 نفر هم برای گروه کنترل).
    نمونه پژوهش حاضر شامل 68 بیمار مبتلا به سرطان پستان هستند که از بین بیماران بیمارستان های شهر تبریز انتخاب و سپس به صورت تصادفی در دو گروه جایگزین شدند: 34 نفر در گروه MBSR و 34 نفر برای گروه لیست انتطار یعنی کنترل.
    After studying and signing consent form, participants are randomly replaced in groups. Subsequently, the test group members will undergo a stress-based education training, after a full explanation of their research and satisfaction from them for 8 weeks, weekly in one session and about two hours and a half to three hours. All subjects will complete all research tools in two rounds. Upon completion of the eight sessions of Mindfulness Training, again, both the test (test and control) will be tested by research tools. The site of the project in the hospital's oncology section Civilized will be Tabriz.
    After the randomization, participants will respond to the informed consent form. Patients in the intervention condition will receive a modified MBSR program for 8 sessions. Prior to performing the intervention, both experimental and control groups will complete the research questionnaires, and after completing 8 sessions of mindfulness training, they will respond to the questionnaires again. The project will be conducted in the oncology department of Tabriz Shahid Madani Hospital.
    پس از مطالعه و امضای فرم رضایت نامه، شرکت کننده ها بصورت تصادفی در گروه ها جایگزین می شوند. پس از آن اعضای گروه آزمایش پس از توضیح کامل در مورد پژوهش و اعلام رضایت از جانب آنها به مدت 8 هفته، بصورت هفته ای یک جلسه و در حدود دوساعت و نیم الی سه ساعت تحت آموزش بهوشیاری مبتنی بر کاهش استرس قرار خواهند گرفت . کلیه آزمودنی ها تمام ابزار پژوهش را در دو نوبت تکمیل خواهند نمود و پس از اتمام 8 جلسه آموزش ذهن آگاهی نیز بار دیگر هر دو گرو(آزمایش و کنترل) به وسیله ابزار های پژوهش، آزمون خواهند شد.محل انجام طرح در بخش آنکولوژی بیمارستان مدنی تبریز خواهد بود.
    پس از جایگزینی تصادفی، شرکت کنندگان فرم رضایت آگاهانه را پاسخ خواهند داد. پس از آن اعضای گروه آزمایش به مدت 8 جلسه، بصورت هفتگی تحت آموزش ذهن آگاهی مبتنی بر کاهش استرس قرار خواهند گرفت . قبل از اجرای مداخله هر دو گروه آزمایش و کنترل ابزاهای پژوهش را تکمیل خواهند کرد و پس از اتمام 8 جلسه آموزش ذهن آگاهی نیز بار دیگر به ابزار های پژوهش را پاسخ خواهند داد.محل انجام طرح در بخش آنکولوژی بیمارستان مدنی تبریز خواهد بود.
    Inclusion criteria: aged over 30; diagnosis of cancer in stages 1 and 2; having at least the literacy; satisfaction to participate in research Exclusion criteria: history of medical diseases; history of psychiatric disorder
    Inclusion criteria: (a) oncologist approved clinical diagnosis of stage I to IV breast cancer; (b) receiving the usual cancer interventions, (c) between 20 to 60 years of age, (d) having at least a high school diploma or equivalent. Exclusion criteria: (a) other chronic diseases; (b) experience practicing yoga and/or meditations; and (c) a history of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
    شرایط ورود به مطالعه: سن بالای 30؛ تشخیص سرطان در مراحل 1 و 2؛ داشتن حداقل سواد؛ تمایل و رضایت برای شرکت در پژوهش شرایط خروج از مطالعه: ابتلا به سایر بیماری های پزشکی؛ ابتلا به یک اختلال روانپزشکی
    شرایط ورود به مطالعه: تشخیص سرطان سینه مراحل یک تا چهار توسط آنکولوژیست، دریافت مداخلات معمول سرطان، سن بین 20 تا 60 ساله، داشتن وضعیت تحصیلی حداقل دیپلم یا برابر آن شرایط خروج از مطالعه: ابتلا به سایر بیماری های مزمن، تجربه تمرین یوگا و یا مدیتیشن، سابقه سوءمصرف الکل، دارو و مواد و همچنین، سابقه اختلالات شخصیت، دمانس و یا اختلالات تحولی
    Experimental group will have mindfulness based stress reduction and control group don't have any interventions.
    Experimental group will have mindfulness based stress reduction and control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions or from participating in any meditations during the trial period. Patients in the waitlist group (control) were invited to take part in the 8-week MBSR program administered by the research team after the study period.
    گروه آزمایش مداخله بهوشیاری مبتنی بر کاهش استرس را دریافت خواهند کرد و گروه کنترل هیچ مداخله ای دریافت نخواهند کرد.
    گروه آزمایش مداخله بهوشیاری مبتنی بر کاهش استرس را دریافت خواهند کرد و از گروه کنترل خواسته شد در طول دوره آزمایشی از شرکت در هر نوع مداخله مبتنی بر ذهن آگاهی یا شرکت در هر مدیتیشن خودداری کنند. بیماران در گروه لیست انتظار (کنترل) برای شرکت در برنامه 8 هفته ای MBSR که توسط تیم تحقیقاتی پس از دوره مطالعه اجرا می شود، دعوت شدند.
    -regulating of negative emotions of breast cancer patients - Improve the hope of these patients -Improve the spiritual well-being of these patients
    -Spiritual well-being - Hope
    -تنظیم عواطف منفی بیماران مبتلا به سرطان پستان -بهبود امیدواری این بیماران -بهبود بهزیستی منفی این بیماران
    -بهزیستی معنوی - امیدواری

  • General information

    MBSR
    30
    20
    Not blinded
    Single blinded
    1
    Supportive
    Treatment
    30
    68
    2018-01-05, 1396/10/15
    2019-09-03, 1398/06/12
    2018-03-06, 1396/12/15
    2019-12-29, 1398/10/08
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    During the recruitment process, the hospital authorities allowed us to have a larger number of patients, and we increased the sample size to increase the generalizability of the findings. We also changed some of the eligibility criteria and outcomes.
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    در طول فرایند انتخاب آزمودنی ها، مسئولین بیمارستان این امکان را در اختیار ما قرار دادند که حجم بیشتری از بیماران را در اختیار داشته باشیم و ما به منظور افزایش میزان تعمیم پذیری یافته ها حجم نمونه را افزایش دادیم. همچنین، تغییراتی را هم در معیارهای واجد شرایط بودن و پیامدها داده ایم.
    Effectiveness of mindfulness Based Stress Reduction (MBSR) on negative emotions, hope and spirituality well-being of women with breast cancer
    The effect of Mindfulness Based Stress Reduction (MBSR) hope and spirituality well-being of women with breast cancer
    اثر بخشی مداخله درمانی کاهش استرس براساس بهوشیاری(MBSR) بر هیجان های منفی، امیدواری و بهزیستی معنوی زنان مبتلا به سرطان پستان
    اثر بخشی مداخله درمانی کاهش استرس براساس بهوشیاری(MBSR) امیدواری و بهزیستی معنوی زنان مبتلا به سرطان پستان
    age up to 30
    Cancer diagnosis in stages 1 and 2
    willingness and Satisfaction to participate in research
    Having at least literacy
    Oncologist approved clinical diagnosis of stage I to IV breast cancer
    Receiving the usual cancer interventions
    Between 20 to 60 years of age
    having at least a high school diploma or equivalent
    سن بالای 30
    تشخیص سرطان در مراحل 1 و 2
    تمایل و رضایت برای شرکت در پژوهش
    داشتن حداقل سواد
    تشخیص سرطان سینه مرحله یک تا چهار توسط آنکولوژیست
    دریافت مداخلات درمانی معمول برای سرطان
    سن بین 20 تا 60 ساله
    داشتن حداقل تحصیلات مقطع دیپلم یا برابر آن
    Getting for other medical conditions
    Having a psychiatric disorder
    Age less than 30 years
    Dissatisfaction to participate in research
    Other chronic diseases
    Experience practicing yoga and/or meditations
    History of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
    ابتلا به سایر بیماری های پزشکی
    ابتلا به یک اختلال روانپزشکی
    سن کمتر از 30 سال
    عدم رضایت برای شرکت در پژوهش
    ابتلا به سایر بیماری های مزمن
    تجربه تمرین یوگا و یا مدیتیشن
    سابقه سوءمصرف الکل، دارو یا مواد، همچنین سابقه اختلالات شخصیت، دمانس و یا اختلالات تحولی
    - simple randomization - through randomization table
    - Block randomization - A list of random numbers generated by SPSS (version 24, SPSS Inc, Chicago, IL)
    -تصادفی سازی ساده - از طریق جدول تصادفی سازی
    -تصادفی سازی بلوک -فهرستی از اعداد تصادفی تولید شده توسط SPSS (نسخه 24، SPSS Inc، شیکاگو، IL)
    empty
    The assessors of the outcome
    empty
    ارزیابی کنندگان پیامد

  • Health conditions studied

    #1
    Brest cancer
    Breast cancer

  • Primary outcomes

    #1
    depression
    Hope
    افسردگی
    امیدواری
    assessing of depression at the beginning of the study and 2 months after intervention
    Measurement of hope at the beginning of the study (before the intervention) and 2 months after intervention
    اندازه گیری افسردگی در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    اندازه گیری امیدواری در ابتدای مطالعه (قبل از شروع مداخله) و 2 ماه پس از شروع مداخله
    Depression, Anxiety and Stress scale
    The Snyder Hope Scale (SHS)
    1.مقیاس افسردگی،اضطراب، استرس داس
    مقیاس امید اشنایدر
    #2
    anxiety
    Spiritual well-being
    اضطراب
    بهزیستی معنوی
    assessing of anxiety at the beginning of the study and 2 months after intervention
    Measurement of spiritual well-being at the beginning of the study (before the intervention) and 2 months after intervention
    اندازه گیری اضطراب در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    اندازه گیری بهزیستی معنوی در ابتدای مطالعه (قبل از شروع مداخله) و 2 ماه پس از شروع مداخله
    Depression, Anxiety and Stress scale
    Spiritual Well Being Scale (SWBS)
    مقیاس افسردگی،اضطراب، استرس داس
    مقیاس بهزیستی معنوی (SWBS)
    #3
    stress
    empty
    استرس
    empty
    assessing of stress at the beginning of the study and 2 months after intervention
    empty
    اندازه گیری استرس در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    empty
    Depression, Anxiety and Stress scale
    empty
    مقیاس افسردگی،اضطراب، استرس داس
    empty
    #4
    Anger
    empty
    خشم
    empty
    assessing of anger at the beginning of the study and 2 months after intervention
    empty
    اندازه گیری خشم در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    empty
    Spielberg's Anger Scale
    empty
    مقیاس خشم اسپیلبرگر
    empty
    #5
    hope
    empty
    امیدواری
    empty
    assessing of hope at the beginning of the study and 2 months after intervention
    empty
    اندازه گیری امیدواری در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    empty
    Schneider's Hope Scale
    empty
    مقیاس امید اشنایدر
    empty
    #6
    spiritual well-being
    empty
    بهزیستی معنوی
    empty
    assessing of spiritual well-being at the beginning of the study and 2 months after intervention
    empty
    اندازه گیری بهزیستی معنوی در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    empty
    Pulotsin and Ellison Spiritual Well-being Scale
    empty
    مقیاس بهزیستی معنوی پولوتزين و اليسون
    empty

  • Secondary outcomes

    #1
    psychological well-being
    empty
    بهزیستی روان شناختی
    empty
    assessing of psychologicall well-being at the beginning of the study and 2 months after intervention
    empty
    اندازه گیری بهزیستی روان شناختی در ابتدای مطالعه و 2 ماه پس از شروع مداخله
    empty
    The Ryff Scales of Psychological Well-Being
    empty
    پرسشنامه بهزیستی روانشناختی ریف
    empty

  • Intervention groups

    #1
    Lifestyle
    Treatment - Other
    Intervention group: Mindfulness based stress reduction is an educational method in which members learn emotion control and concentration techniques once a week and three hours.
    Experimental group: This group underwent MBSR for two months.A qualified therapist, who has basic professional training in mindfulness-based intervention with ten years of experience in conducting mindfulness-based programs, implemented the MBSR program. Control group: The control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions. These patients were invited to take part in the 8-week MBSR program after the study period.
    گروه مداخله: کاهش استرس بر اساس بهوشیاری روشی آموزشی است که اعضای گروه هر هفته یک بار به مدت سه ساعت روش های تمرکز و کنترل هیجان را یاد می گیرند.
    گروه آزمایش: این گروه به مدت دو ماه تحت مداخله کاهش استرس براساس ذهن آگاهی قرار گرفتند. یک درمانگر با تجربه که دارای آموزش های حرفه ای پایه در زمینه مداخله مبتنی بر ذهن آگاهی با ده سال تجربه در اجرای برنامه های مبتنی بر ذهن آگاهی است، برنامه MBSR را اجرا کرد. گروه کنترل: از گروه کنترل خواسته شد از شرکت در هر نوع مداخله مبتنی بر ذهن آگاهی خودداری کنند. این بیماران پس از پایان دوره مطالعه برای شرکت در برنامه 8 هفته ای MBSR دعوت شدند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid madani hospital
    Name of recruitment center - Persian: بیمارستان شهید مدنی
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Street address - English: Golgasht street. Shahid madani hospital
    Street address - Persian: بیمارستان شهید مدنی، خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166616471
    Phone: +98 41 3334 4280
    Fax:
    Email: phsy.heshmati@tbzmed.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Madani Hospital
    Name of recruitment center - Persian: بیمارستان شهید مدنی
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Street address - English: Golgasht street. Shahid Madani Hospital
    Street address - Persian: بیمارستان شهید مدنی، خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166616471
    Phone: +98 41 3334 4280
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abolghasem Jouyban
    Full name of responsible person - Persian: دکتر ابوالقاسم جویبان
    Street address - English: Golgasht Street, Madani Hospital, Tabriz City.
    Street address - Persian: بیمارستان شهید مدنی،بخش آنکولوژی، خیابان گلگشت.
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166616471
    Phone: +98 41 3475 7626
    Fax:
    Email: psy.heshmati@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abolghasem Jouyban
    Full name of responsible person - Persian: دکتر ابوالقاسم جویبان
    Street address - English: Golgasht Street, Shahid Madani Hospital, Tabriz City.
    Street address - Persian: بیمارستان شهید مدنی،بخش آنکولوژی، خیابان گلگشت.
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166616471
    Phone: +98 41 3475 7626
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ّFaculty of psychology, Tabriz university, Tabriz
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده علوم تربیتی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 914 493 3866
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ّFaculty of psychology, University of Tabriz , Tabriz
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده روان شناسی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 919 826 0681
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tabriz university . faculty of psychology
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده علوم تربیتی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 914 493 3866
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Associate Professor
    Position - Persian: داشیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: University of Tabriz, faculty of psychology
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده روان شناسی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 914 826 0681
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of psychology, Tabriz university, Tabriz.
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده علوم تربیتی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 914 493 3866
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Rasoul Heshmati
    Full name of responsible person - Persian: رسول حشمتی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of psychology, University of Tabriz, Tabriz.
    Street address - Persian: تبریز. دانشگاه تبریز. دانشکده روان شناسی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5175698425
    Phone: +98 41 3475 7626
    Mobile: +98 919 826 0681
    Fax:
    Email: psy.heshmati@tabrizu.ac.ir
    Web page address:

  • Sharing plan

    6 month after result publition
    6 month after publication
    Only for the purpose of using data and protocols in other research work
    For use in other research work
    تنها به منظور استفاده از داده ها و پرتکل درمانی در کارهای پژوهشی دیگر
    به منظور استفاده در کارهای پژوهشی دیگر
    Tabriz-University of Tabriz-Department of Psychology-Mr. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com
    University of Tabriz-Department of Psychology- Prof. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com

Protocol summary

Study aim
The effect of Mindfulness Based Stress Reduction (MBSR) on hope and spirituality well-being of women with breast cancer
Design
The sample of this study included 68 breast cancer patients selected from patients at Tabriz Hospitals and randomly allocated into two groups: MBSR group (n=34) and usual care, waitlist group (n=34).
Settings and conduct
After the randomization, participants will respond to the informed consent form. Patients in the intervention condition will receive a modified MBSR program for 8 sessions. Prior to performing the intervention, both experimental and control groups will complete the research questionnaires, and after completing 8 sessions of mindfulness training, they will respond to the questionnaires again. The project will be conducted in the oncology department of Tabriz Shahid Madani Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (a) oncologist approved clinical diagnosis of stage I to IV breast cancer; (b) receiving the usual cancer interventions, (c) between 20 to 60 years of age, (d) having at least a high school diploma or equivalent. Exclusion criteria: (a) other chronic diseases; (b) experience practicing yoga and/or meditations; and (c) a history of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
Intervention groups
Experimental group will have mindfulness based stress reduction and control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions or from participating in any meditations during the trial period. Patients in the waitlist group (control) were invited to take part in the 8-week MBSR program administered by the research team after the study period.
Main outcome variables
-Spiritual well-being - Hope

General information

Reason for update
During the recruitment process, the hospital authorities allowed us to have a larger number of patients, and we increased the sample size to increase the generalizability of the findings. We also changed some of the eligibility criteria and outcomes.
Acronym
MBSR
IRCT registration information
IRCT registration number: IRCT20171203037729N1
Registration date: 2018-01-02, 1396/10/12
Registration timing: prospective

Last update: 2022-05-28, 1401/03/07
Update count: 1
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Rasoul Heshmati
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3475 7626
Email address
psy.heshmati@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-03, 1398/06/12
Expected recruitment end date
2019-12-29, 1398/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Mindfulness Based Stress Reduction (MBSR) hope and spirituality well-being of women with breast cancer
Public title
mindfulness based stress reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oncologist approved clinical diagnosis of stage I to IV breast cancer Receiving the usual cancer interventions Between 20 to 60 years of age having at least a high school diploma or equivalent
Exclusion criteria:
Other chronic diseases Experience practicing yoga and/or meditations History of alcohol, drug and substance abuse, personality disorders, dementia, and/or developmental disorders
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
- Block randomization - A list of random numbers generated by SPSS (version 24, SPSS Inc, Chicago, IL)
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessors of the outcome
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central Building No. 2, Third Floor, Research & Technology Dept. Golghast St, Tabriz University of Medical Sciences.Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
IR.TBZMED.REC.1396.719

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C00-D48
ICD-10 code description
سرطان سینه

Primary outcomes

1

Description
Hope
Timepoint
Measurement of hope at the beginning of the study (before the intervention) and 2 months after intervention
Method of measurement
The Snyder Hope Scale (SHS)

2

Description
Spiritual well-being
Timepoint
Measurement of spiritual well-being at the beginning of the study (before the intervention) and 2 months after intervention
Method of measurement
Spiritual Well Being Scale (SWBS)

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: This group underwent MBSR for two months.A qualified therapist, who has basic professional training in mindfulness-based intervention with ten years of experience in conducting mindfulness-based programs, implemented the MBSR program. Control group: The control group were requested to refrain from taking part in any type of Mindfulness-Based Interventions. These patients were invited to take part in the 8-week MBSR program after the study period.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Rasoul Heshmati
Street address
Golgasht street. Shahid Madani Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 4280
Email
psy.heshmati@tabrizu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht Street, Shahid Madani Hospital, Tabriz City.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3475 7626
Email
psy.heshmati@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Heshmati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
ّFaculty of psychology, University of Tabriz , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Heshmati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Tabriz, faculty of psychology
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rasoul Heshmati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of psychology, University of Tabriz, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Fax
Email
psy.heshmati@tabrizu.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
All data is publishable after being unidentifiable
When the data will become available and for how long
6 month after publication
To whom data/document is available
for all researchers
Under which criteria data/document could be used
For use in other research work
From where data/document is obtainable
University of Tabriz-Department of Psychology- Prof. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com
What processes are involved for a request to access data/document
Requesting from researcher and sending it by post or e-mail
Comments
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