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Protocol summary
A study with parallel clinical trial. We have two in-person and virtual groups and the in-group is control group.
Clinical trial of control group, with randomized double-blind randomized parallel groups on 60 patients. Use of random number table for randomization
A study with parallel clinicalClinical trial. We have two in-person and virtual groups and the in-group is of control group, with randomized double-blind randomized parallel groups on 60 patients. Use of random number table for randomization
مطالعه به روش کارآزمایی بالینی موازی.دو گروه حضوری و مجازی داریم و گروه حضوری گروه کنترل میباشد
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی دو سویه کور تصادفی شده بر روی 60 بیمار.استفاده از جدول اعداد تصادفی برای تصادفی سازی
مطالعه به روش کارآزمایی بالینی موازی.دو گروه حضوری و مجازی داریم و گروه حضوریدارای گروه کنترل میباشد، با گروه های موازی دو سویه کور تصادفی شده بر روی 60 بیمار.استفاده از جدول اعداد تصادفی برای تصادفی سازی
After obtaining informed consent from women undergoing polycystic ovary syndrome, they were then randomly assigned to two groups of virtual mind-body intervention (n = 30) and control group (n = 30). The two groups of 15 people are divided.
The intervention group received 8 sessions of 2-hour counseling with physical therapy approach.
Yazd Diabetes Clinic Study Place
After obtaining informed consent from women undergoing polycystic ovary syndrome, they were then randomly assigned to two groups of virtual mind-body intervention (n = 30) and control group (n = 30). The two groups of 15 people are divided.
The intervention group received 8 sessions of 2-hour counseling with physical therapy approach.Also, fasting blood glucose was measured in the laboratory of the Diabetes Polyclinic twice for the beginning of the study and at the end of week 8 in both groups for free.
Yazd Diabetes Clinic Study Place
After obtaining informed consent from women undergoing polycystic ovary syndrome, they were then randomly assigned to two groups of virtual mind-body intervention (n = 30) and control group (n = 30). The two groups of 15 people are divided. The intervention group received 8 sessions of 2-hour counseling with physical therapy approachapproach.Also, fasting blood glucose was measured in the laboratory of the Diabetes Polyclinic twice for the beginning of the study and at the end of week 8 in both groups for free. Yazd Diabetes Clinic Study Place
پس از اخذ رضایت نامه آگاهانه از زنان تحت درمان سندرم تخمدان پلی کیستیک ، سپس با استفاده از جدول اعداد تصادفی کامپیوتری این زنان به دو گروه مداخله ذهن بدن مجازی (30 نفر= دو گروه پانزده نفره) و شاهد مداخله ذهن بدن حضوری ( 30نفر= دو گروه 15 نفره) تقسیم می گردند.
گروه مداخله طی 8 جلسه مشاوره 2 ساعته با رویکرد درمان ذهنی بدنی قرار گرفتند.
محل انجام مطالعه کلینیک دیابت یزد
پس از اخذ رضایت نامه آگاهانه از زنان تحت درمان سندرم تخمدان پلی کیستیک ، سپس با استفاده از جدول اعداد تصادفی کامپیوتری این زنان به دو گروه مداخله ذهن بدن مجازی (30 نفر= دو گروه پانزده نفره) و شاهد مداخله ذهن بدن حضوری ( 30نفر= دو گروه 15 نفره) تقسیم می گردند.
گروه مداخله طی 8 جلسه مشاوره 2 ساعته با رویکرد درمان ذهنی بدنی قرار گرفتند.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری شد
محل انجام مطالعه کلینیک دیابت یزد
پس از اخذ رضایت نامه آگاهانه از زنان تحت درمان سندرم تخمدان پلی کیستیک ، سپس با استفاده از جدول اعداد تصادفی کامپیوتری این زنان به دو گروه مداخله ذهن بدن مجازی (30 نفر= دو گروه پانزده نفره) و شاهد مداخله ذهن بدن حضوری ( 30نفر= دو گروه 15 نفره) تقسیم می گردند. گروه مداخله طی 8 جلسه مشاوره 2 ساعته با رویکرد درمان ذهنی بدنی قرار گرفتند.گرفتند.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری شد محل انجام مطالعه کلینیک دیابت یزد
Married women of childbearing age, Iranian, literate, for both intervention groups, virtual and mobile, and Internet or iPhone Operating System(ios) for both groups, Polycystic Ovary Syndrome based on Rotterdam criteria and treated Being in a diabetes clinic
Exclusion: Participation in another study, self-reported history of other chronic mental and physical illnesses, use of other medications
Married women of childbearing age, Iranian, literate, for both intervention groups, virtual and mobile, and Internet or iPhone Operating System(ios) for both groups, Polycystic Ovary Syndrome based on Rotterdam criteria and treated Being in a diabetes clinic.Willingness to have a fasting blood sugar test before the study and after the end of week 8
Exclusion: Participation in another study, self-reported history of other chronic mental and physical illnesses, use of other medications
Married women of childbearing age, Iranian, literate, for both intervention groups, virtual and mobile, and Internet or iPhone Operating System(ios) for both groups, Polycystic Ovary Syndrome based on Rotterdam criteria and treated Being in a diabetes clinicclinic.Willingness to have a fasting blood sugar test before the study and after the end of week 8 Exclusion: Participation in another study, self-reported history of other chronic mental and physical illnesses, use of other medications
زنان متاهل سنین باروری، ایرانی، برخورداری از سواد خواندن و نوشتن، برای هردو گروه مداخله مجازی و حضوری و برخورداری از سواد اینترنتی و تلفن همراه اندروید یا سیستم عامل آیفون
(آی او اس ) برای هردو گروه ، داشتن پرونده ابتلاء به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام و تحت درمان قرار داشتن در کلینیک دیابت
عدم ورود:شرکت همزمان در مطالعه دیگر،سابقه ابتلا به سایر بیماری های روانی و جسمی مزمن به اظهار خود فرد،مصرف سایر داروها
زنان متاهل سنین باروری، ایرانی، برخورداری از سواد خواندن و نوشتن، برای هردو گروه مداخله مجازی و حضوری و برخورداری از سواد اینترنتی و تلفن همراه اندروید یا سیستم عامل آیفون
(آی او اس ) برای هردو گروه ، داشتن پرونده ابتلاء به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام و تحت درمان قرار داشتن در کلینیک دیابت.•داشتن تمایل به انجام آزمایش قند خون ناشتا قبل از انجام مطالعه و بعد از اتمام هفته 8
عدم ورود:شرکت همزمان در مطالعه دیگر،سابقه ابتلا به سایر بیماری های روانی و جسمی مزمن به اظهار خود فرد،مصرف سایر داروها
زنان متاهل سنین باروری، ایرانی، برخورداری از سواد خواندن و نوشتن، برای هردو گروه مداخله مجازی و حضوری و برخورداری از سواد اینترنتی و تلفن همراه اندروید یا سیستم عامل آیفون (آی او اس ) برای هردو گروه ، داشتن پرونده ابتلاء به سندرم تخمدان پلی کیستیک بر اساس معیار روتردام و تحت درمان قرار داشتن در کلینیک دیابت.•داشتن تمایل به انجام آزمایش قند خون ناشتا قبل از انجام مطالعه و بعد از اتمام هفته 8 عدم ورود:شرکت همزمان در مطالعه دیگر،سابقه ابتلا به سایر بیماری های روانی و جسمی مزمن به اظهار خود فرد،مصرف سایر داروها
Determining and comparing mean quality of life scores
. Determining and comparing mean scores of satisfaction with virtual and in-person counseling
Quality of Life,
Satisfaction with the virtual and face-to-face counseling method,
Fasting blood sugar
Determining and comparing mean qualityQuality of life scores . Determining and comparing mean scores of satisfactionLife, Satisfaction with the virtual and inface-personto-face counseling method, Fasting blood sugar
تعیین و مقایسه میانگین نمرات کیفیت زندگی
. تعیین و مقایسه میانگین نمرات رضایتمندی از روش مشاوره مجازی و حضوری
کیفیت زندگی،
رضایتمندی از روش مشاوره مجازی و حضوری،
قند خون ناشتا
تعیین و مقایسه میانگین نمرات کیفیت زندگی . تعیین و مقایسه میانگین نمرات، رضایتمندی از روش مشاوره مجازی و حضوری، قند خون ناشتا
General information
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60
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2019-10-09, 1398/07/17
2019-10-23, 1398/08/01
2019-10-0923 00:00:00
2020-01-07, 1398/10/17
2019-12-24, 1398/10/03
20202019-0112-0724 00:00:00
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2020-04-27, 1399/02/08
2020-04-27 00:00:00
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2020-06-23, 1399/04/03
2020-06-23 00:00:00
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2020-09-23, 1399/07/02
2020-09-23 00:00:00
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Restriction of words and failure to include a blood sugar test
Restriction of words and failure to include a blood sugar test
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محدودیت کلمات و عدم وارد کردن سنجش قند خون
محدودیت کلمات و عدم وارد کردن سنجش قند خون
Secondary outcomes
#1
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Fasting blood sugar
Fasting blood sugar
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قند خون ناشتا
قند خون ناشتا
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At the beginning of the study and after the end of week 8
At the beginning of the study and after the end of week 8
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در ابتدای مطالعه و بعد از اتمام هفته 8
در ابتدای مطالعه و بعد از اتمام هفته 8
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Glucometer device
Glucometer device
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دستگاه گلوکومتر
دستگاه گلوکومتر
Intervention groups
#1
Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.
Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMSSMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
گروه مداخله: مشاوره مجازی ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک . برای گروه مجازی مشاوره بعد از تشکیل کانال در نرم افزار شبکه مجازی واتساپ (پروتکل مشاوره طی هشت جلسه مشاوره دوساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) انجام میشود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا میشود. به این ترتیب که زنان در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری می شود.
گروه مداخله: مشاوره مجازی ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک . برای گروه مجازی مشاوره بعد از تشکیل کانال در نرم افزار شبکه مجازی واتساپ (پروتکل مشاوره طی هشت جلسه مشاوره دوساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) انجام میشود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا میشود. به این ترتیب که زنان در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری می شود.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری میشود
گروه مداخله: مشاوره مجازی ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک . برای گروه مجازی مشاوره بعد از تشکیل کانال در نرم افزار شبکه مجازی واتساپ (پروتکل مشاوره طی هشت جلسه مشاوره دوساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) انجام میشود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا میشود. به این ترتیب که زنان در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری می شود.شود.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری میشود
#2
control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.
control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMSSMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
گروه کنترل: مشاوره حضوری ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک. در گروه حضوری جلسات (پروتکل مشاوره طی هشت جلسه مشاوره دو ساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) مشاوره بصورت حضوری برای دو گروه پانزده نفره در کلینیک دیابت یزد به علت دارا بودن امکانات و فضای کافی انجام می شود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا می شود. به این ترتیب که زنان در مشاوره حضوری در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری شد.
گروه کنترل: مشاوره حضوری ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک. در گروه حضوری جلسات (پروتکل مشاوره طی هشت جلسه مشاوره دو ساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) مشاوره بصورت حضوری برای دو گروه پانزده نفره در کلینیک دیابت یزد به علت دارا بودن امکانات و فضای کافی انجام می شود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا می شود. به این ترتیب که زنان در مشاوره حضوری در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری شد.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری میشود
گروه کنترل: مشاوره حضوری ذهنی بدنی برای زنان مبتلا به سندرم تخمدان پلی کیستیک. در گروه حضوری جلسات (پروتکل مشاوره طی هشت جلسه مشاوره دو ساعته با رویکرد درمانی مبتنی بر ذهن بدن و تکنیک های این روش شامل ذهن آگاهی، مراقبه، تکنیک های تنفس، تجسم خلاق و مواجهه می باشد) مشاوره بصورت حضوری برای دو گروه پانزده نفره در کلینیک دیابت یزد به علت دارا بودن امکانات و فضای کافی انجام می شود. این مطالعه به صورت پیش آزمون، پس آزمون (هفته 8 و هفته 12 بعد از مداخله) اجرا می شود. به این ترتیب که زنان در مشاوره حضوری در ابتدای مطالعه، اتمام هفته هشت، اتمام هفته دوازده علاوه بر سوالات دموگرافیک، پرسشنامه گونه ایرانی کیفیت زندگی و نیز پذیرش و رضایتمندی از رویکرد و روش مشاوره ای را به صورت خودگزارش دهی تکمیل کردند و تکالیف خانگی هر روز از طریق پیامک به افراد یادآوری شد.شد.همچنین اندازه گیری قندخون ناشتا در آزمایشگاه پلی کلینیک دیابت دو مرتبه ابتدای مطالعه و اتمام هفته 8 در دو گروه به صورت رایگان اندازه گیری میشود
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.tahmineh farajkhoda
Full name of responsible person - Persian: دکتر تهمینه فرج خدا
Street address - English: boali Ave
Street address - Persian: خیابان بوعلی
City - English: yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915878818
Phone: +98 35 3724 0171
Fax:
Email: info@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Yazd University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی یزد
Full name of responsible person - English: Dr. Massoud Mirzaei
Full name of responsible person - Persian: دکتر مسعود میرزایی
Street address - English: Yazd Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address - Persian: یزد میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد طبقه سوم
City - English: yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173143
Phone: +98 35 3726 3733
Fax:
Email: info@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Yazd University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی یزد Full name of responsible person - English: Dr.tahmineh farajkhodaDr. Massoud Mirzaei Full name of responsible person - Persian: دکتر تهمینه فرج خدامسعود میرزایی Street address - English: boali AveYazd Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Street address - Persian: خیابان بوعلییزد میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد طبقه سوم City - English: yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 89158788188915173143 Phone: +98 35 3724 01713726 3733 Fax: Email: info@ssu.ac.ir Web page address:
Yazd University of Medical Sciences
Vice chancellor for research, Yazd University of Medical Sciences
Vice chancellor for research, Yazd University of Medical Sciences
دانشگاه علوم پزشکی یزد
معاونت پژوهشی دانشگاه علوم پزشکی یزد
معاونت پژوهشی دانشگاه علوم پزشکی یزد
#2
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Yazd University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی یزد
Full name of responsible person - English: Dr. Massoud Mirzaei
Full name of responsible person - Persian: دکتر مسعود میرزایی
Street address - English: Yazd Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address - Persian: یزد میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد طبقه سوم
City - English: yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: 8915173143
Phone: +98 35 3726 3733
Fax:
Email: info@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Yazd University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی یزد Full name of responsible person - English: Dr. Massoud Mirzaei Full name of responsible person - Persian: دکتر مسعود میرزایی Street address - English: Yazd Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran Street address - Persian: یزد میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد طبقه سوم City - English: yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: 8915173143 Phone: +98 35 3726 3733 Fax: Email: info@ssu.ac.ir Web page address:
Yes
empty
1
60
empty
60
Public
empty
public
Domestic
empty
domestic
Academic
empty
academic
Vice chancellor for research, Yazd University of Medical Sciences
empty
Vice chancellor for research, Yazd University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی یزد
empty
معاونت پژوهشی دانشگاه علوم پزشکی یزد
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Tahmineh Farajkhoda
Full name of responsible person - Persian: دکتر تهمینه فرج خدا
Position - English: استادیار
Position - Persian: Assistant Professor
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: BOALI AVE
Street address - Persian: خیابان بوعلی
City - English: YAZD
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8915878818
Phone: +98 35 3725 8770
Mobile: +98 913 353 3125
Fax:
Email: Farajkhoda_t@Yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Tahmineh Farajkhoda
Full name of responsible person - Persian: دکتر تهمینه فرج خدا
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Boali Ave
Street address - Persian: خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8915878818
Phone: +98 35 3725 8770
Mobile: +98 913 353 3125
Fax:
Email: Farajkhoda_t@Yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Tahmineh Farajkhoda Full name of responsible person - Persian: دکتر تهمینه فرج خدا Position - English: استادیارAssistant Professor Position - Persian: Assistant Professorاستادیار Latest degree: phd Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: BOALI AVEBoali Ave Street address - Persian: خیابان بوعلی City - English: YAZDYazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8915878818 Phone: +98 35 3725 8770 Mobile: +98 913 353 3125 Fax: Email: Farajkhoda_t@Yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.tahmineh faraj khoda
Full name of responsible person - Persian: دکتر تهمینه فرج خدا
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Boali ave
Street address - Persian: خیابان بوعلی
City - English: yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8915878818
Phone: +98 35 3725 8770
Mobile: +98 913 353 3125
Fax:
Email: farajkhoda_t@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Tahmineh Farajkhoda
Full name of responsible person - Persian: دکتر تهمینه فرج خدا
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Boali Ave
Street address - Persian: خیابان بوعلی
City - English: Yazd
City - Persian: یزد
Province: Yazd
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8915878818
Phone: +98 35 3725 8770
Mobile: +98 913 353 3125
Fax:
Email: farajkhoda_t@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.tahmineh faraj khodaDr.Tahmineh Farajkhoda Full name of responsible person - Persian: دکتر تهمینه فرج خدا Position - English: Assistant Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Boali aveAve Street address - Persian: خیابان بوعلی City - English: yazdYazd City - Persian: یزد Province: Yazd Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8915878818 Phone: +98 35 3725 8770 Mobile: +98 913 353 3125 Fax: Email: farajkhoda_t@yahoo.com Web page address:
Protocol summary
Study aim
Determining and Comparing the Effectiveness of Mind-Body Intervention in Two Virtual-in-person Methods on Quality of Life in Women with Polycystic Ovary Syndrome
Design
Clinical trial of control group, with randomized double-blind randomized parallel groups on 60 patients. Use of random number table for randomization
Settings and conduct
After obtaining informed consent from women undergoing polycystic ovary syndrome, they were then randomly assigned to two groups of virtual mind-body intervention (n = 30) and control group (n = 30). The two groups of 15 people are divided.
The intervention group received 8 sessions of 2-hour counseling with physical therapy approach.Also, fasting blood glucose was measured in the laboratory of the Diabetes Polyclinic twice for the beginning of the study and at the end of week 8 in both groups for free.
Yazd Diabetes Clinic Study Place
Participants/Inclusion and exclusion criteria
Married women of childbearing age, Iranian, literate, for both intervention groups, virtual and mobile, and Internet or iPhone Operating System(ios) for both groups, Polycystic Ovary Syndrome based on Rotterdam criteria and treated Being in a diabetes clinic.Willingness to have a fasting blood sugar test before the study and after the end of week 8
Exclusion: Participation in another study, self-reported history of other chronic mental and physical illnesses, use of other medications
Intervention groups
Intervention group: Virtual physical counseling group. Control group: Physical Mental Counseling (8 sessions of two-hour physical counseling) before and after the eighth and twelfth week of quality of life in women with polycystic ovary syndrome
Main outcome variables
Quality of Life,
Satisfaction with the virtual and face-to-face counseling method,
Fasting blood sugar
General information
Reason for update
Restriction of words and failure to include a blood sugar test
Acronym
IRCT registration information
IRCT registration number:IRCT20190916044783N1
Registration date:2020-04-19, 1399/01/31
Registration timing:prospective
Last update:2021-01-03, 1399/10/14
Update count:1
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
maryam javanbakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5748 8268
Email address
m.javanbakht@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-24, 1398/10/03
Actual recruitment start date
2020-04-27, 1399/02/08
Actual recruitment end date
2020-06-23, 1399/04/03
Trial completion date
2020-09-23, 1399/07/02
Scientific title
Effectiveness Comparison of Body- Mind Intervention in Virtual and Face to Face Method on Quality of Life in Polycystic Ovary Syndrome
Public title
Effectiveness of Body- Mind Intervention in Virtual and Face to Face Method on Quality of Life in Polycystic Ovary Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women of childbearing age
Iranian ethnicity
Literacy for reading and writing
Internet literacy and android or i o s mobile phone for both group
Having a pco case based on Rotterdam criteria and being treated at a diabetes clinic
Having a tendency to do FBS test before study and after 8 week
Willingness to participate in the study
Exclusion criteria:
pregnancy
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer random number table
The researcher will begin to provide you with a framework for your statistical community, and you can guide yourself to 60 people who are known and invited as an official source. The researcher used to schedule tables for the visible sample of his eyes in the form of tables and fingers or the tip of a pen. Move between different levels or columns using this and employers to request funding. The selected number is actually the personality code of the budget community that is chosen by the sample. Each code, for example, was assigned to members of a virtual counseling group or face-to-face counseling so that you could arrange your samples in each group of 30 people.The final samples were called to a specific location, the purpose and method of work, and the right to freely participate or not to participate in the research were explained to them. Samples that did not wish to attend the sessions were excluded from the study. Then the required number of samples (30 people for each group) was selected. We again divided the members of each group by throwing coins into two groups of fifteen (B and A) so that if the milk procedure was visible, it belonged to group A, and if the line procedure appeared, it would belong to group B.
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
Ethics Committee of Yazd University of Medical Sciences
Street address
Shahid ghandi Ave, negin complex
City
yazd
Province
Yazd
Postal code
8915878818
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.SSU.REC.1398.004
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Quality of Life in Patients with Polycystic Ovary Syndrome
Timepoint
Evaluation of quality of life in patients with polycystic ovary syndrome before study and after 8 and 12 weeks
Method of measurement
Iranian Amini et al. Quality of Life Questionnaire
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after the end of week 8
Method of measurement
Glucometer device
Intervention groups
1
Description
Intervention group:virtual counseling of body-mind intervention on quality of life in polycystic ovary syndrome . For the virtual consulting team after forming a channel in the WhatsApp Virtual Network Software (Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ) Is done. This study is performed as pre-test, post-test (week 8 and week 12 after intervention). At the beginning of the study, women completed eight weeks, twelve weeks in addition to demographic questions, a questionnaire of Iranian quality of life, as well as acceptance and satisfaction of a counseling approach and method of self-reporting. Reminds people via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
Category
N/A
2
Description
control group:face to face counseling of body-mind intervention on quality of life in polycystic ovary syndrome . In-person group sessions (eight two-hour sessions) In-person counseling is provided for two groups of 15 in the Yazd Diabetes Clinic due to lack of facilities and space. This study is a pre-test, post-test(Consultation protocol over 8 sessions of 2-hour counseling with mind-body-based therapeutic approach and techniques of this method include mindfulness, meditation, breathing techniques, creative visualization and exposure. ). Thus, women completed in-person counseling at the beginning of the study, completion of week 8, completion of twelve weeks in addition to demographic questions, Iranian quality of life questionnaire, and acceptance and satisfaction of the counseling approach and method of self-reporting and homework assignments. People were reminded daily via SMS.Also, fasting blood sugar measurement in the laboratory of Diabetes Polyclinic is measured twice at the beginning of the study and at the end of week 8 in both groups for free.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd ِDiabetes Polyclinic
Full name of responsible person
Dr,M. Rahmanian
Street address
Bahonar Ave
City
YAZD
Province
Yazd
Postal code
8915878818
Phone
+98 35 3728 0226
Email
Ghadiriam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Yazd Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3726 3733
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Yazd University of Medical Sciences
Proportion provided by this source
60
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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Tahmineh Farajkhoda
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Boali ave
City
Yazd
Province
Yazd
Postal code
8915878818
Phone
+98 35 3725 8770
Email
Farajkhoda_t@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Tahmineh Farajkhoda
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Boali Ave
City
Yazd
Province
Yazd
Postal code
8915878818
Phone
+98 35 3725 8770
Email
Farajkhoda_t@Yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Tahmineh Farajkhoda
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Boali Ave
City
Yazd
Province
Yazd
Postal code
8915878818
Phone
+98 35 3725 8770
Email
farajkhoda_t@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available