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Protocol summary
This study is a clinical trial study on 90 students of Qom University of Medical Sciences. In a recall of students who have criteria for entering the study, they are continuously enrolled in the study. They were recruited by bilingual blocking method in two groups is randomly assigned. Demographic questionnaire and menstrual status are completed first by all samples. Individuals in both groups are initially examined in a basic cycle and are not involved in this intervention cycle, and only all individuals complete the course registration form. Then interventions are performed in two groups in two menstrual cycles, and the form for recording the course information, including menstruation, verbal multi-dimensional scoring system and pain ruler, is completed.
This study is a clinical trial study on 90 students of Qom University of Medical Sciences. In recall of students who have criteria for entering the study, they are continuously enrolled in the study. They were recruited by quadruple blocking method in two groups is randomly assigned. A demographic questionnaire and menstrual status are completed first by all samples. Individuals in both groups are initially examined in a basic cycle and are not involved in this intervention cycle, and only all individuals complete the course registration form. Then interventions are performed in two groups in two menstrual cycles, and the form for recording the course information, including menstruation, verbal multi-dimensional scoring system, and pain ruler, is completed.
This study is a clinical trial study on 90 students of Qom University of Medical Sciences. In a recall of students who have criteria for entering the study, they are continuously enrolled in the study. They were recruited by bilingualquadruple blocking method in two groups is randomly assigned. DemographicA demographic questionnaire and menstrual status are completed first by all samples. Individuals in both groups are initially examined in a basic cycle and are not involved in this intervention cycle, and only all individuals complete the course registration form. Then interventions are performed in two groups in two menstrual cycles, and the form for recording the course information, including menstruation, verbal multi-dimensional scoring system, and pain ruler, is completed.
این مطالعه به صورت کارآزمایی بالینی بر روی 90 نفر از دانشجویان دانشگاه علوم پزشکی قم انجام می شود.طی یک فراخوان دانشجویانی که معیار های ورود به مطالعه را دارند، به صورت مستمر وارد مطالعه می شوند و به روش بلوک دوتایی در دو گروه اوریکولوتراپی و مفنامیک اسید به صورت تصادفی تخصیص می یابند. پرسشنامه جمعیت شناختی و وضعیت قاعدگی در ابتدا توسط تمام نمونه ها تکمیل می گردد. افراد در هر دو گروه ابتدا در یک سیکل پایه مورد بررسی قرار می گیرند و در این سیکل مداخله ای انجام نشده و فقط کلیه افراد فرم ثبت اطلاعات دوره پایه را تکمیل می کنند. سپس مداخلات در دو گروه در دو سیکل قاعدگی انجام می شود و فرم ثبت اطلاعات دوره درمان که شامل وضعیت قاعدگی، سیستم امتیازدهی چند بعدی کلامی و خط کش درد می باشد تکمیل می شود.
این مطالعه به صورت کارآزمایی بالینی بر روی 90 نفر از دانشجویان دانشگاه علوم پزشکی قم انجام می شود.طی یک فراخوان دانشجویانی که معیار های ورود به مطالعه را دارند، به صورت مستمر وارد مطالعه می شوند و به روش بلوک چهارتایی در دو گروه اوریکولوتراپی و مفنامیک اسید به صورت تصادفی تخصیص می یابند. پرسشنامه جمعیت شناختی و وضعیت قاعدگی در ابتدا توسط تمام نمونه ها تکمیل می گردد. افراد در هر دو گروه ابتدا در یک سیکل پایه مورد بررسی قرار می گیرند و در این سیکل مداخله ای انجام نشده و فقط کلیه افراد فرم ثبت اطلاعات دوره پایه را تکمیل می کنند. سپس مداخلات در دو گروه در دو سیکل قاعدگی انجام می شود و فرم ثبت اطلاعات دوره درمان که شامل وضعیت قاعدگی، سیستم امتیازدهی چند بعدی کلامی و خط کش درد می باشد تکمیل می شود.
این مطالعه به صورت کارآزمایی بالینی بر روی 90 نفر از دانشجویان دانشگاه علوم پزشکی قم انجام می شود.طی یک فراخوان دانشجویانی که معیار های ورود به مطالعه را دارند، به صورت مستمر وارد مطالعه می شوند و به روش بلوک دوتاییچهارتایی در دو گروه اوریکولوتراپی و مفنامیک اسید به صورت تصادفی تخصیص می یابند. پرسشنامه جمعیت شناختی و وضعیت قاعدگی در ابتدا توسط تمام نمونه ها تکمیل می گردد. افراد در هر دو گروه ابتدا در یک سیکل پایه مورد بررسی قرار می گیرند و در این سیکل مداخله ای انجام نشده و فقط کلیه افراد فرم ثبت اطلاعات دوره پایه را تکمیل می کنند. سپس مداخلات در دو گروه در دو سیکل قاعدگی انجام می شود و فرم ثبت اطلاعات دوره درمان که شامل وضعیت قاعدگی، سیستم امتیازدهی چند بعدی کلامی و خط کش درد می باشد تکمیل می شود.
General information
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2018-12-22, 1397/10/01
2019-03-01, 1397/12/10
20182019-1203-2201 00:00:00
2019-04-21, 1398/02/01
2019-07-11, 1398/04/20
2019-0407-2111 00:00:00
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2019-03-03, 1397/12/12
2019-03-03 00:00:00
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2019-07-15, 1398/04/24
2019-07-15 00:00:00
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2019-07-15, 1398/04/24
2019-07-15 00:00:00
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- Due to the prolonged approval and coding process, start and end date recruitment were changed.
-The random allocation to each group performed using a four-block size, which explained previously in the section Randomization description. But in protocol abstract, there is a double block, a typographical error that was changed to four-block size.
- Overall, for people with different menstrual cycles according to the previously mentioned inclusion criteria (menstrual cycle 24-32 days with menstrual length 3-7 days), auriculotherapy is performed between a minimum of 2-3 and a maximum of 3-4 sessions per cycle. during implementation, we noticed that in the relevant section was corrected.
- Due to the prolonged approval and coding process, start and end date recruitment were changed. -The random allocation to each group performed using a four-block size, which explained previously in the section Randomization description. But in protocol abstract, there is a double block, a typographical error that was changed to four-block size. - Overall, for people with different menstrual cycles according to the previously mentioned inclusion criteria (menstrual cycle 24-32 days with menstrual length 3-7 days), auriculotherapy is performed between a minimum of 2-3 and a maximum of 3-4 sessions per cycle. during implementation, we noticed that in the relevant section was corrected.
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- با توجه به طولانی شدن مراحل تأیید و گرفتن کد، تاریخ شروع و پایان بیمار گیری تغییر کرد.
-تخصیص تصادفی به هر گروه با استفاده از بلوک در سایز چهار انجام شد که قبلا در بخش توصیف تصادفی سازی توضیح داده شده است. اما در چکیده پروتکل، یک بلوک دوتایی وجود دارد که یک خطای تایپی است که به بلوک در سایز چهار تغییر یافت.
- در مجموع برای افراد با سیکل های قاعدگی متفاوت طبق معیارهای ورود قبلا ذکر شده (سیکل قاعدگی 24 – 32 روز با طول قاعدگی 3 – 7 روز) اوریکولوتراپی بین حداقل 2-3 و حداکثر 3 – 4 جلسه در هر سیکل انجام می شود که حین اجرای کار متوجه این موضوع شدیم که در قسمت مربوطه اصلاح گردید.
- با توجه به طولانی شدن مراحل تأیید و گرفتن کد، تاریخ شروع و پایان بیمار گیری تغییر کرد. -تخصیص تصادفی به هر گروه با استفاده از بلوک در سایز چهار انجام شد که قبلا در بخش توصیف تصادفی سازی توضیح داده شده است. اما در چکیده پروتکل، یک بلوک دوتایی وجود دارد که یک خطای تایپی است که به بلوک در سایز چهار تغییر یافت. - در مجموع برای افراد با سیکل های قاعدگی متفاوت طبق معیارهای ورود قبلا ذکر شده (سیکل قاعدگی 24 – 32 روز با طول قاعدگی 3 – 7 روز) اوریکولوتراپی بین حداقل 2-3 و حداکثر 3 – 4 جلسه در هر سیکل انجام می شود که حین اجرای کار متوجه این موضوع شدیم که در قسمت مربوطه اصلاح گردید.
Intervention groups
#1
Intervention group: In the ariculotherapy group, it was explained to each person that ariculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the intervention was performed between 6 and 4 times in each intervention cycle. This practice was carried out by a trained researcher with a degree in ariculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated.
Intervention group: In the auriculotherapy group, it was explained to each person that auriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the ariculotherapy was performed from at least 2-3 to a maximum of 3 to 4 sessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in auriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated.
Intervention group: In the ariculotherapyauriculotherapy group, it was explained to each person that ariculotherapyauriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the interventionariculotherapy was performed between 6 andfrom at least 2-3 to a maximum of 3 to 4 times insessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in ariculotherapyauriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated.
گروه مداخله: در گروه اوریکولوتراپی برای هر فرد توضیح داده شد که اوریکولوتراپی یک بار در هفته به صورت هر 6 روز یکبار به مدت 2 سیکل قاعدگی برای هر فرد انجام می شود و مداخله از پایان یک قاعدگی آغاز و تا پایان یافتن درد قاعدگی بعد ادامه پیدا می کند. در مجموع برای افراد با سیکل های قاعدگی متفاوت طبق معیار ورود بین 6-4 مرتبه در هر سیکل مداخله انجام شد. این عمل توسط پژوهشگر آموزش دیده دارای مدرک اوریکولوتراپی، در یک محیط خصوصی که برای این منظور تعبیه شد، انجام گرفت. در آخرین جلسه اوریکولوتراپی نزدیک قاعدگی بعد در 4 نقطه در هر دو گوش سید های گیاهی تعبیه شد و به افراد توضیح داده شد که فشار دادن سیدها را در ابتدا شروع درد قاعدگی آغاز کنند و هر نقطه را برای 1 دقیقه 6-4 بار در روز به فاصله حداقل 1 ساعت فشار دهند و فشار دادن نقاط در روز را تا پایان یافتن درد قاعدگی ادامه دهند و سپس 24 ساعت بعد از رهایی از درد، سیدها برداشته شود. سید ها در محل می توانست به مدت 7 روز باقی بمانند. برای جلوگیری از فراموشی، فشردن سیدها به صورت تلفنی و از طریق گروه مجازی یادآوری شد. قدرت فشار سید ها باید تا حدی باشد که درد و سوزش در گوش خارجی ایجاد کند. به آنها همچنین اطلاع داده شد که ممکن است احساس های مختلف در حال فشار سیدها از جمله بی حسی، تورم، درد خفیف یا گرما تجربه کنند.به افراد توضیح داده شد که سیدها به راحتی کنده نمی شوند و چسب های آن نسبت به روغن بدن واکنش نشان نمی دهند و به راحتی از گوش جدا نمی شوند. در صورت حمام رفتن، گوش صرفا با آب شسته شود و تا زمان خشک شدن گوش به سید ها دست زده نشود و در صورت جدا شدن سید به محقق اطلاع داده شود.برای برداشتن سیدها بهتر است بیمار گوش خود را به سمت پایین (زمین) نگه داشته و سپس آن را جدا نماید.به ترتیب 11 نقطه برای تسکین دیسمنوره استفاده شد شامل: نقاط اصلی شن من، تالامیک، نقطه زیرو و نقطه اندوکرین و نقاط آناتومیکی رحم، ژنیتال، تخمدان و نقاط حمایت کننده کلیه، لگن، واگ و نقطه پروستاگلاندین می باشد. تحریک الکتریکی گوش پس از ضد عفونی گوش با الکل70 درصد و یک دقیقه ماساژ عمومی گوش جهت آرام سازی، از طریق پوست در نقاط با دستگاه پوینتر اکسل 2 و با فرکانس 2 هرتز و شدت جریان 4-2 میلی آمپر، به مدت 20 ثانیه روی هر نقطه، توسط پژوهشگر اعمال گردید. در جلسه آخر نزدیک قاعدگی بعدی در 4 نقطه شن من، تالامیک، رحم و لگن سید گذاشته شد.
گروه مداخله: در گروه اوریکولوتراپی برای هر فرد توضیح داده می شود که اوریکولوتراپی یک بار در هفته به صورت هر 6 روز یکبار به مدت 2 سیکل قاعدگی برای هر فرد انجام می شود و مداخله از پایان یک قاعدگی آغاز و تا پایان یافتن درد قاعدگی بعد ادامه پیدا می کند. در مجموع برای افراد با سیکل های قاعدگی متفاوت طبق معیار ورود بین حداقل 2-3 و حداکثر 3 – 4 جلسه اوریکولوتراپی در هر سیکل انجام می شود. این عمل توسط پژوهشگر آموزش دیده دارای مدرک اوریکولوتراپی، در یک محیط خصوصی که برای این منظور تعبیه شد، انجام گرفت. در آخرین جلسه اوریکولوتراپی نزدیک قاعدگی بعد در 4 نقطه در هر دو گوش سید های گیاهی تعبیه شد و به افراد توضیح داده شد که فشار دادن سیدها را در ابتدا شروع درد قاعدگی آغاز کنند و هر نقطه را برای 1 دقیقه 6-4 بار در روز به فاصله حداقل 1 ساعت فشار دهند و فشار دادن نقاط در روز را تا پایان یافتن درد قاعدگی ادامه دهند و سپس 24 ساعت بعد از رهایی از درد، سیدها برداشته شود. سید ها در محل می توانست به مدت 7 روز باقی بمانند. برای جلوگیری از فراموشی، فشردن سیدها به صورت تلفنی و از طریق گروه مجازی یادآوری شد. قدرت فشار سید ها باید تا حدی باشد که درد و سوزش در گوش خارجی ایجاد کند. به آنها همچنین اطلاع داده شد که ممکن است احساس های مختلف در حال فشار سیدها از جمله بی حسی، تورم، درد خفیف یا گرما تجربه کنند.به افراد توضیح داده شد که سیدها به راحتی کنده نمی شوند و چسب های آن نسبت به روغن بدن واکنش نشان نمی دهند و به راحتی از گوش جدا نمی شوند. در صورت حمام رفتن، گوش صرفا با آب شسته شود و تا زمان خشک شدن گوش به سید ها دست زده نشود و در صورت جدا شدن سید به محقق اطلاع داده شود.برای برداشتن سیدها بهتر است بیمار گوش خود را به سمت پایین (زمین) نگه داشته و سپس آن را جدا نماید.به ترتیب 11 نقطه برای تسکین دیسمنوره استفاده شد شامل: نقاط اصلی شن من، تالامیک، نقطه زیرو و نقطه اندوکرین و نقاط آناتومیکی رحم، ژنیتال، تخمدان و نقاط حمایت کننده کلیه، لگن، واگ و نقطه پروستاگلاندین می باشد. تحریک الکتریکی گوش پس از ضد عفونی گوش با الکل70 درصد و یک دقیقه ماساژ عمومی گوش جهت آرام سازی، از طریق پوست در نقاط با دستگاه پوینتر اکسل 2 و با فرکانس 2 هرتز و شدت جریان 4-2 میلی آمپر، به مدت 20 ثانیه روی هر نقطه، توسط پژوهشگر اعمال گردید. در جلسه آخر نزدیک قاعدگی بعدی در 4 نقطه شن من، تالامیک، رحم و لگن سید گذاشته شد.
گروه مداخله: در گروه اوریکولوتراپی برای هر فرد توضیح داده شدمی شود که اوریکولوتراپی یک بار در هفته به صورت هر 6 روز یکبار به مدت 2 سیکل قاعدگی برای هر فرد انجام می شود و مداخله از پایان یک قاعدگی آغاز و تا پایان یافتن درد قاعدگی بعد ادامه پیدا می کند. در مجموع برای افراد با سیکل های قاعدگی متفاوت طبق معیار ورود بین 6حداقل 2-3 و حداکثر 3 – 4 مرتبهجلسه اوریکولوتراپی در هر سیکل مداخله انجام شدمی شود. این عمل توسط پژوهشگر آموزش دیده دارای مدرک اوریکولوتراپی، در یک محیط خصوصی که برای این منظور تعبیه شد، انجام گرفت. در آخرین جلسه اوریکولوتراپی نزدیک قاعدگی بعد در 4 نقطه در هر دو گوش سید های گیاهی تعبیه شد و به افراد توضیح داده شد که فشار دادن سیدها را در ابتدا شروع درد قاعدگی آغاز کنند و هر نقطه را برای 1 دقیقه 6-4 بار در روز به فاصله حداقل 1 ساعت فشار دهند و فشار دادن نقاط در روز را تا پایان یافتن درد قاعدگی ادامه دهند و سپس 24 ساعت بعد از رهایی از درد، سیدها برداشته شود. سید ها در محل می توانست به مدت 7 روز باقی بمانند. برای جلوگیری از فراموشی، فشردن سیدها به صورت تلفنی و از طریق گروه مجازی یادآوری شد. قدرت فشار سید ها باید تا حدی باشد که درد و سوزش در گوش خارجی ایجاد کند. به آنها همچنین اطلاع داده شد که ممکن است احساس های مختلف در حال فشار سیدها از جمله بی حسی، تورم، درد خفیف یا گرما تجربه کنند.به افراد توضیح داده شد که سیدها به راحتی کنده نمی شوند و چسب های آن نسبت به روغن بدن واکنش نشان نمی دهند و به راحتی از گوش جدا نمی شوند. در صورت حمام رفتن، گوش صرفا با آب شسته شود و تا زمان خشک شدن گوش به سید ها دست زده نشود و در صورت جدا شدن سید به محقق اطلاع داده شود.برای برداشتن سیدها بهتر است بیمار گوش خود را به سمت پایین (زمین) نگه داشته و سپس آن را جدا نماید.به ترتیب 11 نقطه برای تسکین دیسمنوره استفاده شد شامل: نقاط اصلی شن من، تالامیک، نقطه زیرو و نقطه اندوکرین و نقاط آناتومیکی رحم، ژنیتال، تخمدان و نقاط حمایت کننده کلیه، لگن، واگ و نقطه پروستاگلاندین می باشد. تحریک الکتریکی گوش پس از ضد عفونی گوش با الکل70 درصد و یک دقیقه ماساژ عمومی گوش جهت آرام سازی، از طریق پوست در نقاط با دستگاه پوینتر اکسل 2 و با فرکانس 2 هرتز و شدت جریان 4-2 میلی آمپر، به مدت 20 ثانیه روی هر نقطه، توسط پژوهشگر اعمال گردید. در جلسه آخر نزدیک قاعدگی بعدی در 4 نقطه شن من، تالامیک، رحم و لگن سید گذاشته شد.
Protocol summary
Study aim
Determination of effect of ariculotherapy and mefenamic acid on the severity of primary dysmenorrhea and associated with it
Design
Randomized clinical trial with control group
Settings and conduct
This study is a clinical trial study on 90 students of Qom University of Medical Sciences. In recall of students who have criteria for entering the study, they are continuously enrolled in the study. They were recruited by quadruple blocking method in two groups is randomly assigned. A demographic questionnaire and menstrual status are completed first by all samples. Individuals in both groups are initially examined in a basic cycle and are not involved in this intervention cycle, and only all individuals complete the course registration form. Then interventions are performed in two groups in two menstrual cycles, and the form for recording the course information, including menstruation, verbal multi-dimensional scoring system, and pain ruler, is completed.
Participants/Inclusion and exclusion criteria
Single, Iranian, 18-35 years old, Dysmenorrhea with degrees 2- 3 according to verbal multi-dimensional criteria, absence of chronic disease , non-use of pill prevention and weight loss, lack of exercise history,lack of body mass over 30, no smoking, earlessness in ariculotherapy, lack of history of ariculotherapy.
Intervention groups
In auriculotherapy group, intervention is done once a week in 2 cycles of menstruation. At the end of the closing session, the menstrual period is placed seeds at 4 points, and squeezing the seeds 4-6 times a day initially begins the onset of menstrual pain. In the mefenamic acid group, taking the 250 mg capsule first takes 2 capsules for the first menstrual symptom, followed by a capsule every 6 hours, and continues until pain is reduced.
Main outcome variables
Severity of primary dysmenorrhea and general symptoms associated with it
General information
Reason for update
- Due to the prolonged approval and coding process, start and end date recruitment were changed.
-The random allocation to each group performed using a four-block size, which explained previously in the section Randomization description. But in protocol abstract, there is a double block, a typographical error that was changed to four-block size.
- Overall, for people with different menstrual cycles according to the previously mentioned inclusion criteria (menstrual cycle 24-32 days with menstrual length 3-7 days), auriculotherapy is performed between a minimum of 2-3 and a maximum of 3-4 sessions per cycle. during implementation, we noticed that in the relevant section was corrected.
Acronym
IRCT registration information
IRCT registration number:IRCT20181207041873N1
Registration date:2019-02-24, 1397/12/05
Registration timing:prospective
Last update:2020-02-06, 1398/11/17
Update count:1
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Seyedeh Batool Hasanpoor-Azghady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 0021
Email address
hasanpoor.sb@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
2019-03-03, 1397/12/12
Actual recruitment end date
2019-07-15, 1398/04/24
Trial completion date
2019-07-15, 1398/04/24
Scientific title
Comprasion of the Effect of Auriculotherapy and Mefenamic Acid on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it in students
Public title
Effect of Auriculotherapy a on Primary Dysmenorrhea Severity and Systemic Symptoms associated with it
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being single
Iranian nationality
Age of 35-18 years
Having regular menstrual periods (length of 3-7 days and the interval between two menstrual periods 32-32 days) in the last two cycles
Having primary dysmenorrhea with rejection of secondary dysmenorrhea with the diagnosis of a specialist
Having menstrual pain as a colic or crampy pain in the suprapubic line, sometimes spreading to the lower back and groin that begins with menstruation and lasts for 2-3 days
Primary dysmenorrhea with degrees 2 and 3 according to verbal multi-dimensional criteria
Experience primary dysmenorrhea in most menstrual cycles
External ear on both sides without lumps, swelling, infection or ulcers in the group of Auriculotherapy
Exclusion criteria:
Lack of any known chronic disease and absence of a pacemaker
No history of anemia, weakness
Non-use of contraceptive pills over the past three months
Failure to lose weight during the study
Not having a regular exercise activity during the 3 months before the start of the study
Lack of body mass index of more than 30 kg per square meter
Not having a history of pelvic inflammatory diseases, endometriosis, myoma, and pelvic tumors with the diagnosis of a doctor
Non-use of tobacco (cigarettes, hookahs and narcotics) and alcohol
No history of any abdominal and pelvic surgery or abnormal ultrasound of the uterus
Non-occurrence of severe psychological stress in the last 6 months, such as parental separation, death of first degree relatives and surgical procedures
Having no history of mood disorders with expert diagnosis
No history of treatment with Auriculotherapy in the last 6 months
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
83
Randomization (investigator's opinion)
Randomized
Randomization description
A researcher at a recall in Qom University of Medical Sciences, after his introduction, explains the sufficient information about the research, including the title of research, the goals of the study, the criteria for entering and leaving the study, the manner and manner of conducting the study for students. Individuals who wish to participate in research with primary dysmenorrhea and inclusion criteria are referred to the researcher by telephone for their research, and are included in the continuous sampling method. The research units are then assigned to the two groups of Auricolotherapy and Mefenamic acid by randomization. In a block random method, quadrilateral blocks are created, in which randomly, half of each block is placed in one group and the other half in the other group. In this study, we want to identify 90 people in two groups of 45 patients with Auricolotherapy and Mefenamic acid, first we identify all four-state states in which half of the people are assigned in the Auricolotherapy group and the other half in the Mefenamic acid group. Then, to each of these four-state combinations that include six modes, we assign one of the digits 1-6. Then we select 25 randomly random numbers from 1 to 6, and we write the combinations of it in succession, and the subjects enter into two groups.
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 Committees of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.IUMS.REC.1397.550
Health conditions studied
1
Description of health condition studied
Primary Dysmenorrhea and Systemic Symptoms associated with it
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of primary dysmenorrhea
Timepoint
Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention
Method of measurement
Visual Analogue Scale
2
Description
General symptoms associated with dysmenorrhea
Timepoint
Measurement in three cycles of menstruation including basal cycle, first and second cycle of menstruation in intervention
Method of measurement
Verbal Multidimensional Scoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the auriculotherapy group, it was explained to each person that auriculotherapy is started once every 6 days for 2 cycles of menstruation for each person, and the intervention begins at the end of a menstrual period and continues until the end of the menstrual period. . Totally, for women with different menstrual cycles, the ariculotherapy was performed from at least 2-3 to a maximum of 3 to 4 sessions per cycle each intervention cycle. This practice was carried out by a trained researcher with a degree in auriculotherapy, in a private environment that was designed for this purpose. At the last session of near-menstrual at 4 drops, both ears of herbs were inserted into the ear and explained to people that initiating the onset of the syndrome initially began the onset of menstrual pain, and each point for 1 minute 6 to 4 times a day Press at intervals of at least 1 hour and continue pressing the dots until the end of the menstrual period, and then remove the acne from the pain for 24 hours after relieving pain. Seed in place could stay for 7 days. To avoid forgetting, squeezing the syndas was reminded by telephone and through the virtual group. The strength of the seizures should be such as to cause pain and burning in the outer ear. They were also informed that various feelings might be felt by the pressure of the blood vessels, such as numbness, swelling, mild pain, or heat. People were told that the cheeks were not easily removed and their adhesives relative to body oil They do not react and can not be easily removed from the ear. In the case of going to the bath, the ears should only be washed with water, and until the drying of the ears, do not touch the syringes and inform the researcher if Seyed is detached. To remove the worms, it is best for the patient to put his ears down (ground) The 11 points used to relieve dysmenorrhea were used: the main points of my gravel, thalamic, ziro point and endocrine point, and the anatomical points of the uterus, genitals, ovaries, and the supporting regions of the kidneys, pelvis, vagus, and The prostaglandin is the point. Electric stimulation of the ear after ear disinfection with 70% alcohol and 1 minute of general massage of the ear for relaxation, through the skin at points with a 2-point pointer machine, with a frequency of 2 Hz and a current of 4-2 mA for 20 seconds. Each point was applied by the researcher. At the end of the closing session, the next menstrual period was placed at 4 points in my gravel, thalamic, uterus, and pelvic seated.
Category
Treatment - Other
2
Description
Control group: In the mefenamic acid group, people were told to use a 250 mg mefenamic acid capsule during the two menstrual cycles to make the Amin Pharmaceuticals company with the first symptom of menstrual start, such as cramp, pain or bleeding. How to use it was that the first time 2 capsules and then every 6 hours to take a capsule and continue until pain relief. The study units were told to follow this intervention for both menstruation cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
دانشگاه علوم پزشکی قم
Full name of responsible person
معصومه واحدی
Street address
Shahid Lavasani St. (Coastal) - Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
m.vahedi_89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayed Kazem Malekoti
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Vahedi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No, 98, 1 Aly. Sadogh Ave, Qom Town
City
Qom
Province
Tehran
Postal code
3716647859
Phone
+98 25 3290 1223
Email
m.vahedi_89@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1907755551
Phone
+98 21 2286 0021
Email
hasanpoor.sb@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Vahedi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No, 98, 1 Aly. Sadogh Ave, Qom Town
City
Qom
Province
Ghoum
Postal code
3716647859
Phone
+98 25 3290 1223
Email
m.vahedi_89@yahoo.com
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
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
Yes - There is 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
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Data for researchers and people who are engaged in treatment can apply for them
Under which criteria data/document could be used
Data for researchers and people who are engaged in treatment can apply for them
From where data/document is obtainable
by Email
m.vahedi_89@yahoo.com
What processes are involved for a request to access data/document