History
# Registration date Revision Id
3 2019-05-15, 1398/02/25 90584
2 2014-01-19, 1392/10/29 14662
1
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  • Protocol summary

    This randomized control clinical trial will be conducted on 65 hemodialysis patients in Vasei hospitals in Sabzevar. This study is planned to evaluate the effect of Benson relaxation on fatigue and depression in hemodialysis patients. the trail will be performed in 65 patients between 18 to 65 years of age Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease Exclusion criteria: Reluctance to continue participating in the exercises; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Kidney transplant; Death . After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. No intervention will be made in control group. Brief Fatigue Inventory (BFI) questionnaire and Beck depression questionnaire will complete by all patients before and 2 week and 4 week after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
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    این مطالعه کارآزمایی بالینی تصادفی شده شاهد دار با هدف تاثیر آرام سازی بنسون بر میزان خستگی و افسردگی بر روی 65 بیمار همودیالیزی بین 18 تا 65 سال در بیمارستان واسعی شهر سبزوارانجام خواهد شد. معیار ورود به مطالعه: سن بین 18 تا 65 سال داشته باشند; حداقل 6 ماه سابقه دیالیز داشته باشد; دارای پرونده فعال دیالیز در مرکز دیالیز سبزوار باشند (بیمار دیالیزی مهمان یا دیالیزی دوره ای نباشند); ناتوانی جسمی یا بیماری مزمن نداشته باشند. معیار های خروج از مطالعه: عدم تمایل بیمار; بروز هر گونه بیماری یا ناتوانی شدید (غیر از دیابت و پرفشاری خون) پیوند کلیه؛ فوت بیمار . پس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، بیماران به روش تخصیص تصادفی به دو گروه ،(33 نفر )گروه مداخله و (32 نفر)گروه کنترل تقسیم خواهند شد. پس از کسب رضایت از بیماران، به بیماران گروه مداخله آموزش آرام سازی بنسون با نوار ویدیویی داده می شود و جهت استفاده در منزل یک نسخه نوار ویدیویی و پمفلت آموزشی را در اختیار بیمار گذاشته می شود. آرام سازی بنسون بمدت یک ماه ، هر روز دو بار و هر بار 15 دقیقه توسط بیماران در گروه مداخله انجام خواهد شد. در گروه کنترل هیچگونه مداخله ای انجام نخواهد شد. سپس پرسشنامه خستگی و افسردگی بک قبل از مداخله، دوهفته و چهار هفته بعد از مداخله توسط کلیه بیماران در هر دو گروه پر خواهد شد و در صورت عدم توانایی بیمار در خواندن یا نوشتن، پرسشنامه توسط محقق و بر اساس اظهارات بیمار پر می شود.
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    evaluate the effect of Benson relaxation on fatigue, depression and daily activities in hemodialysis patients.
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    هدف تاثیر آرام سازی بنسون بر میزان خستگی، افسردگی و فعالیت های روزانه بیماران تحت درمان با همودیالیز
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    This study was a clinical trial with control group with parallel design. The sample size of 65 patients was randomly divided into two equal groups.
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    این مطالعه از نوع کارآزمایی بالینی دارای گروه کنترل، با طرح موازی است که با حجم نمونه 65 بیمار به روش تصادفی شده به دو گروه مساوی تقسیم شدند.
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    Vasei Hospital in Sabzevar
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    بیمارستان واسعی شهر سبزوار
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    Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease.
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    سن بین 18 تا 65 سال داشته باشند; حداقل 6 ماه سابقه دیالیز داشته باشد; دارای پرونده فعال دیالیز در مرکز دیالیز سبزوار باشند (بیمار دیالیزی مهمان یا دیالیزی دوره ای نباشند)، ناتوانی جسمی یا بیماری مزمن نداشته باشند.
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    After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. No intervention will be made in control group. Brief Fatigue Inventory (BFI) questionnaire, Beck depression and Nottingham Questionnaire questionnaire will complete by all patients before and 2 week and 4 week after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
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    پس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، بیماران به روش تخصیص تصادفی به دو گروه ،(33 نفر )گروه مداخله و (32 نفر)گروه کنترل تقسیم خواهند شد. پس از کسب رضایت از بیماران، به بیماران گروه مداخله آموزش آرام سازی بنسون با نوار ویدیویی داده می شود و جهت استفاده در منزل یک نسخه نوار ویدیویی و پمفلت آموزشی را در اختیار بیمار گذاشته می شود. آرام سازی بنسون بمدت یک ماه ، هر روز دو بار و هر بار 15 دقیقه توسط بیماران در گروه مداخله انجام خواهد شد. در گروه کنترل هیچگونه مداخله ای انجام نخواهد شد. سپس پرسشنامه خستگی، افسردگی بک و پرسشنامه ناتینگهام قبل از مداخله، دوهفته و چهار هفته بعد از مداخله توسط کلیه بیماران در هر دو گروه پر خواهد شد و در صورت عدم توانایی بیمار در خواندن یا نوشتن، پرسشنامه توسط محقق و بر اساس اظهارات بیمار پر می شود.
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    Fatigue, depression and daily activities
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    خستگی، افسردگی و فعالیت های روزانه
  • General information

    Effect of benson relaxation on fatigue and depression
    Effect of benson relaxation on fatigue, depression and Daily Activities
    تأثیر آرامسازی بنسون بر خستگی و افسردگی همودیالیز
    تأثیر آرامسازی بنسون بر خستگی، افسردگی و فعالیت های روزانه همودیالیز
    Effect of benson relaxation on fatigue and depression in hemodialysis patients
    Effect of benson relaxation on fatigue, depression and Daily Activities in hemodialysis patients
    بررسی تأثیر آرامسازی بنسون بر خستگی و افسردگی بیماران همودیالیزی
    بررسی تأثیر آرامسازی بنسون بر خستگی، افسردگی و فعالیت های روزانه بیماران همودیالیزی
    Aged between 18 to 65 years
    History of hemodialysis more than 6 months
    ; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers
    Absent of disability or chronic disease
    سن بین 18 تا 65 سال داشته باشند
    حداقل 6 ماه سابقه دیالیز داشته باشد
    دارای پرونده فعال دیالیز در مرکز دیالیز سبزوار باشند (بیمار دیالیزی مهمان یا دیالیزی دوره ای نباشند)
    ناتوانی جسمی یا بیماری مزمن نداشته باشند
    Reluctance to continue participating in the exercises
    Presence of disability or chronic disease, Except diabetes or hypertension
    Kidney transplant
    Death
    عدم تمایل به ادامه شرکت در تمرینات
    بروز هر گونه بیماری یا ناتوانی شدید (غیر از دیابت و پرفشاری خون)
    پیوند کلیه
    فوت بیمار
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    Random allocation with random numbers
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    تخصیص تصادفی با جدول اعداد تصادفی
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    65 number
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    65
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  • Primary outcomes

    #1
    Brief Fatigue Inventory (BFI)
    Brief Fatigue Inventory (BFI), Beck Depression and Nottingham
    پرسشنامه خلاصه شده خستگی(BFI)
    پرسشنامه خلاصه شده خستگی(BFI)، افسردگی بک و ناتینگهام
  • Intervention groups

    #1
    After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month.Brief Fatigue Inventory (BFI) questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements. After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, patients will be divided randomly into two equal groups:33 patients in experimental and 32 in control group.NO intervention in control group. Brief Fatigue Inventory (BFI) questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements.
    After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month.Brief Fatigue Inventory (BFI), Depression and daily activities questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements. After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, patients will be divided randomly into two equal groups:33 patients in experimental and 32 in control group.No intervention in control group.
    :گروه مداخله پس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، تعداد 65 بیمار به دو گروه مساوی ( 33 نفر گروه مداخله و 32 نفر گروه کنترل) تقسیم خواهند شد. ابتدا به بیماران گروه مداخله آموزش آرام سازی بنسون با نوار ویدیویی داده می شود و یک نسخه نوار ویدیویی و پمفلت آموزشی جهت استفاده در منزل در اختیار بیمار گذاشته می شود که بمدت یک ماه ، هر روز دو بار و هر بار 15 دقیقه آرام سازی بنسون توسط بیمار انجام می گردد . سپس پرسشنامه خلاصه شده خستگی قبل و 2 هفته بعد او 4 هفته بعد ز مداخله توسط بیماران گروه مداخله پر می گردد. پرسشنامه توسط محقق و بر اساس اظهارات دقیق بیمار پر می شود گروه کنترل:. پس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، تعداد 65بیمار به دو گروه مساوی ( 33 نفر گروه مداخله و 32 نفر گروه کنترل) تقسیم خواهند شد در گروه كنترل هيچگونه مداخله اي انجام نخواهد شد. سپس پرسشنامه خلاصه شده خستگی قبل و 2 هفته بعد او 4 هفته بعد ز مداخله توسط بیماران گروه مداخله پر می گردد. پرسشنامه توسط محقق و بر اساس اظهارات دقیق بیمار پر می شود.
    :گروه مداخلهپس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، تعداد 65 بیمار به دو گروه مساوی ( 33 نفر گروه مداخله و 32 نفر گروه کنترل) تقسیم خواهند شد. ابتدا به بیماران گروه مداخله آموزش آرام سازی بنسون با نوار ویدیویی داده می شود و یک نسخه نوار ویدیویی و پمفلت آموزشی جهت استفاده در منزل در اختیار بیمار گذاشته می شود که بمدت یک ماه ، هر روز دو بار و هر بار 15 دقیقه آرام سازی بنسون توسط بیمار انجام می گردد . سپس پرسشنامه خلاصه شده خستگی، افسردگی و فعالیت های روزانه قبل و 2 هفته بعد او 4 هفته بعد ز مداخله توسط بیماران گروه مداخله پر می گردد. پرسشنامه توسط محقق و بر اساس اظهارات دقیق بیمار پر می شودگروه کنترل: پس از اخذ مجوز از کمیته اخلاق معاونت پژوهشی دانشگاه علوم پزشکی سبزوار و کسب رضایت از بیماران همودیالیزی جهت ورود به مطالعه، تعداد 65بیمار به دو گروه مساوی ( 33 نفر گروه مداخله و 32 نفر گروه کنترل) تقسیم خواهند شد در گروه كنترل هيچگونه مداخله اي انجام نخواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Sabzevar Vasei hospital
    Name of recruitment center - Persian: بیمارستان واسعی سبزوار
    Full name of responsible person - English: Mehran Hosseini
    Full name of responsible person - Persian: مهران حسینی
    Street address - English:
    Street address - Persian:
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Sabzevar Vasei hospital
    Name of recruitment center - Persian: بیمارستان واسعی سبزوار
    Full name of responsible person - English: Mehran Hosseini
    Full name of responsible person - Persian: مهران حسینی
    Street address - English: Shohadaye Hasteii Boulevard, Sabzevar Vasei hospital
    Street address - Persian: بلوار شهدای هسته ای، بیمارستان واسعی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913114
    Phone: +98 51 4401 1000
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Moosa Reza Tadayonfar
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر
    Street address - English: Sabzevar University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moosa Reza Tadayonfar
    Full name of responsible person - Persian: آقای موسی الرضا تدین فر
    Street address - English: Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
    Street address - Persian: سبزوار - بلوار شهدای هسته ای- بالاتر از مزار شهدای گمنام -پردیس دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Narjes Heshmatifar
    Full name of responsible person - Persian: نرجس حشمتی فر
    Position - English: Student of MSc Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
    Street address - Persian: سبزوار، جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 915 174 1810
    Mobile: 00
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Narjes Heshmatifar
    Full name of responsible person - Persian: نرجس حشمتی فر
    Position - English: Student of MSc Nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
    Street address - Persian: سبزوار - بلوار شهدای هسته ای- بالاتر از مزار شهدای گمنام -پردیس دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Mobile: +98 915 174 1810
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Scinces
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Mohsen Koushan
    Full name of responsible person - Persian: محسن کوشان
    Position - English: MSc./Member of Faculty
    Position - Persian: کارشناسی ارشد/ عضو هیئت علمی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Sabzevar University of Medical Science
    Street address - Persian: دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 57 1444 6070
    Mobile: 00
    Fax:
    Email: mkoushan@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohsen Koushan
    Full name of responsible person - Persian: محسن کوشان
    Position - English: MSc./Member of Faculty
    Position - Persian: کارشناسی ارشد/ عضو هیئت علمی
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
    Street address - Persian: سبزوار - بلوار شهدای هسته ای- بالاتر از مزار شهدای گمنام -پردیس دانشگاه علوم پزشکی سبزوار
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Mobile: +98 915 174 1810
    Fax:
    Email: mkoushan@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Sabzevar University of Medical Scinces
    Name of organization / entity - Persian: دانشگاه علوم پزشکی سبزوار
    Full name of responsible person - English: Narjes Heshmati Far
    Full name of responsible person - Persian: نرجس حشمتی فر
    Position - English: Student of MSc Nursing
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
    Street address - Persian: سبزوار،جنب پلیس راه شاهرود، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: +91 51741810
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Narjes Heshmati Far
    Full name of responsible person - Persian: نرجس حشمتی فر
    Position - English: Faculty member of Sabzevar University
    Position - Persian: عضو هیئت علمی دانشگاه علوم پزشکی سبزوار
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
    Street address - Persian: سبزوار، بلوار شهدای هسته ای، دانشکده پرستاری و مامایی
    City - English: Sabzevar
    City - Persian: سبزوار
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9617913112
    Phone: +98 51 4401 1000
    Mobile: +91 51741810
    Fax:
    Email: nheshmatifar@yahoo.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    There is no more information.
    empty
    اطلاعات بیشتری وجود ندارد.

Protocol summary

Study aim
evaluate the effect of Benson relaxation on fatigue, depression and daily activities in hemodialysis patients.
Design
This study was a clinical trial with control group with parallel design. The sample size of 65 patients was randomly divided into two equal groups.
Settings and conduct
Vasei Hospital in Sabzevar
Participants/Inclusion and exclusion criteria
Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease.
Intervention groups
After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. No intervention will be made in control group. Brief Fatigue Inventory (BFI) questionnaire, Beck depression and Nottingham Questionnaire questionnaire will complete by all patients before and 2 week and 4 week after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
Main outcome variables
Fatigue, depression and daily activities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2014011115393N2
Registration date: 2014-01-19, 1392/10/29
Registration timing: registered_while_recruiting

Last update: 2019-05-19, 1398/02/29
Update count: 1
Registration date
2014-01-19, 1392/10/29
Registrant information
Name
Narjes Heshmati Far
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
nheshmatifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of benson relaxation on fatigue, depression and Daily Activities in hemodialysis patients
Public title
Effect of benson relaxation on fatigue, depression and Daily Activities
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 65 years History of hemodialysis more than 6 months ; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers Absent of disability or chronic disease
Exclusion criteria:
Reluctance to continue participating in the exercises Presence of disability or chronic disease, Except diabetes or hypertension Kidney transplant Death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation with random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2013-12-06, 1392/09/15
Ethics committee reference number
92.7.medsab.Rec

Health conditions studied

1

Description of health condition studied
End stage renal failure
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
Fatigue in hemodialysis patients
Timepoint
before, 2week and 4 week after intervention
Method of measurement
Brief Fatigue Inventory (BFI), Beck Depression and Nottingham

Secondary outcomes

empty

Intervention groups

1

Description
After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month.Brief Fatigue Inventory (BFI), Depression and daily activities questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements. After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, patients will be divided randomly into two equal groups:33 patients in experimental and 32 in control group.No intervention in control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabzevar Vasei hospital
Full name of responsible person
Mehran Hosseini
Street address
Shohadaye Hasteii Boulevard, Sabzevar Vasei hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Email
nheshmatifar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
nheshmatifar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Narjes Heshmatifar
Position
Student of MSc Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Fax
Email
nheshmatifar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohsen Koushan
Position
MSc./Member of Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Fax
Email
mkoushan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Narjes Heshmati Far
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Fax
Email
nheshmatifar@yahoo.com
Web page address

Sharing plan

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