Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Arash Hospital
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Protocol summary
The study is a single-blind randomized clinical trial to evaluate the effect of acupressure on nausea and vomiting of pregnant women. The study included pregnant women who referred to health care centers at Tehran. 128 eligible pregnant women who complain of nausea and vomiting related to pregnancy. Will be allocated randomly in two groups: intervention and control. The subjects won’t receive any intervention at the first two days after initial of the study and the intervention will be done between third to sixth day after initial of the study.in the intervention group, the magnetic seeds with a special adhesive latex will be attached in five effective points of ears for controlling the nausea and vomiting. Then patient will be asked for making pressure on each points for at least 30 seconds, three times a day.in the control group will be acted the same, but non effective points on nausea and vomiting will be used. Both groups will be asked for completing Rhodes questionnaire for evaluating nausea and vomiting every night for six days. Rhodez questionnaire for evaluation of nausea and vomiting on a daily basis and will be completed in six days for both groups.
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The study is a single-blind randomized clinical trial to evaluate the effect of acupressure on nausea and vomiting of pregnant women. The study included pregnant women who referred to health care centers at Tehran. 128 eligible pregnant women who complain of nausea and vomiting related to pregnancy. Will be allocated randomly in two groups: intervention and control. The subjects won’t receive any intervention at the first two days after initial of the study and the intervention will be done between third to sixth day after initial of the study.in the intervention group, the magnetic seeds with a special adhesive latex will be attached in five effective points of ears for controlling the nausea and vomiting. Then patient will be asked for making pressure on each points for at least 30 seconds, three times a day.in the control group will be acted the same, but non effective points on nausea and vomiting will be used. Both groups will be asked for completing Rhodes questionnaire for evaluating nausea and vomiting every night for six days. Rhodez questionnaire for evaluation of nausea and vomiting on a daily basis and will be completed in six days for both groups.
پژوهش حاضر از نوع کارآزمایی بالینی تصادفی یک سو کور می باشد که با هدف بررسی تاثیر طب فشاری گوش بر تهوع و استفراغ ناشی از حاملگی انجام خواهد شد. این مطالعه بر روی زنان باردار مراجعه کننده به مراکز بهداشتی درمانی شهر تهران انجام می شود. 128 خانم باردار که از تهوع و استفراغ بارداری شکایت دارند، با توجه به معیارهای ورود و خروج مطالعه انتخاب خواهند شد و بطور تصادفی در دو گروه مداخله و کنترل قرار خواهند گرفت. روش کار در گروه آزمون به این صورت است که در دو روز اول پس از ورود به مطالعه هیچ گونه مداخله ای انجام نمی شود و مداخله از روز سوم شروع و تا روز ششم ادامه دارد. در گروه مداخله پس از مراجعه در روز سوم توسط پژوهشگر، در 5 نقطه گوش که در کنترل تهوع و استفراغ موثر هستند، یک دانه مغناطیسی گذاشته و با چسب مخصوص غیر لاتکس چسبانیده می شود. سپس از بیماران خواسته می شود که هر نقطه را به مدت حداقل 30 ثانیه و سه بار در روز(صبح، ظهر و شب) فشار بدهند. در گروه کنترل نیز به همین شکل عمل می کنند با این تفاوت که نقاطی که این دانه های مغناطیسی قرار می گیرند هیچ گونه تاثیری بر تهوع و استفراغ ندارند. جهت بررسی تهوع و استفراغ بیماران پرسشنامه رودز به صورت روزانه و به مدت شش روز برای هر دو گروه تکمیل خواهد شد.
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پژوهش حاضر از نوع کارآزمایی بالینی تصادفی یک سو کور می باشد که با هدف بررسی تاثیر طب فشاری گوش بر تهوع و استفراغ ناشی از حاملگی انجام خواهد شد. این مطالعه بر روی زنان باردار مراجعه کننده به مراکز بهداشتی درمانی شهر تهران انجام می شود. 128 خانم باردار که از تهوع و استفراغ بارداری شکایت دارند، با توجه به معیارهای ورود و خروج مطالعه انتخاب خواهند شد و بطور تصادفی در دو گروه مداخله و کنترل قرار خواهند گرفت. روش کار در گروه آزمون به این صورت است که در دو روز اول پس از ورود به مطالعه هیچ گونه مداخله ای انجام نمی شود و مداخله از روز سوم شروع و تا روز ششم ادامه دارد. در گروه مداخله پس از مراجعه در روز سوم توسط پژوهشگر، در 5 نقطه گوش که در کنترل تهوع و استفراغ موثر هستند، یک دانه مغناطیسی گذاشته و با چسب مخصوص غیر لاتکس چسبانیده می شود. سپس از بیماران خواسته می شود که هر نقطه را به مدت حداقل 30 ثانیه و سه بار در روز(صبح، ظهر و شب) فشار بدهند. در گروه کنترل نیز به همین شکل عمل می کنند با این تفاوت که نقاطی که این دانه های مغناطیسی قرار می گیرند هیچ گونه تاثیری بر تهوع و استفراغ ندارند. جهت بررسی تهوع و استفراغ بیماران پرسشنامه رودز به صورت روزانه و به مدت شش روز برای هر دو گروه تکمیل خواهد شد.
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to evaluate the effect of auriculotherapy on nausea and vomiting during pregnancy.
to evaluate the effect of auriculotherapy on nausea and vomiting during pregnancy.
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تعیین تاثیر طب فشاری گوش بر تهوع و استفراغ دوران بارداری
تعیین تاثیر طب فشاری گوش بر تهوع و استفراغ دوران بارداری
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This study is a double blind randomized controlled clinical trial with parallel groups. sample of 64 individuals for each group was suggested accordingly
This study is a double blind randomized controlled clinical trial with parallel groups. sample of 64 individuals for each group was suggested accordingly
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این مطالعه از نوع کارآزمایی بالینی تصادفی شاهد دار دو سو کور است که به صورت موازی انجام شده است. تعداد نمونه 64 نفر در هر گروه محاسبه شد
این مطالعه از نوع کارآزمایی بالینی تصادفی شاهد دار دو سو کور است که به صورت موازی انجام شده است. تعداد نمونه 64 نفر در هر گروه محاسبه شد
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The research setting was the prenatal center of Arash Women’s Hospital affiliated to Tehran University of Medical Sciences. patient and a statistics expert was blind.
The research setting was the prenatal center of Arash Women’s Hospital affiliated to Tehran University of Medical Sciences. patient and a statistics expert was blind.
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محیط پژوهش مرکز پره ناتال بیمارستان زنان آرش وابسته به دانشگاه علوم پزشکی تهران بود. بیماران و متخصص امار در این مطالعه از تخصیص افراد بی اطلاع بودند
محیط پژوهش مرکز پره ناتال بیمارستان زنان آرش وابسته به دانشگاه علوم پزشکی تهران بود. بیماران و متخصص امار در این مطالعه از تخصیص افراد بی اطلاع بودند
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Inclusion criteria include mild to moderate nausea and vomiting according to Rhodes’ Standard Index; women of 18 to 35 years old; in the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography; single pregnancy; and literacy.
While exclusion criteria include severe nausea and vomiting; hyperemesis gravidarum during pregnancy; other symptoms such as diarrhea indicating pathologic nature of nausea and vomiting; and any other disease that causes or aggravates the symptoms of nausea and vomiting and results in abortion.
Inclusion criteria include mild to moderate nausea and vomiting according to Rhodes’ Standard Index; women of 18 to 35 years old; in the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography; single pregnancy; and literacy. While exclusion criteria include severe nausea and vomiting; hyperemesis gravidarum during pregnancy; other symptoms such as diarrhea indicating pathologic nature of nausea and vomiting; and any other disease that causes or aggravates the symptoms of nausea and vomiting and results in abortion.
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معیارهای ورود به مطالعه شامل: وجود تهوع و استفراغ خفیف و متوسط ناشی از بارداری بر اساس معیار مشخص استاندارد رودز Rhodes Index، زنان 18-35 سال، سن بارداری 6-16 هفته بر اساس اولین روز آخرین قاعدگی مطمئن یا سونوگرافی، بارداری تک قلو با جنین طبیعی و زنده و داشتن سواد خواندن و نوشتن.
معیارهای خروج از مطالعه شامل: بروز تهوع و استفراغ شدید، بروز تهوع و استفراغ بدخیم ناشی از حاملگی، وجود علائم دیگری مانند اسهال که نشان دهنده پاتولوژیک بودن تهوع و استفراغ است و بروز هر گونه بیماری که علائم تهوع و استفراغ را ایجاد و یا تشدید کند و ختم بارداری می باشند.
معیارهای ورود به مطالعه شامل: وجود تهوع و استفراغ خفیف و متوسط ناشی از بارداری بر اساس معیار مشخص استاندارد رودز Rhodes Index، زنان 18-35 سال، سن بارداری 6-16 هفته بر اساس اولین روز آخرین قاعدگی مطمئن یا سونوگرافی، بارداری تک قلو با جنین طبیعی و زنده و داشتن سواد خواندن و نوشتن. معیارهای خروج از مطالعه شامل: بروز تهوع و استفراغ شدید، بروز تهوع و استفراغ بدخیم ناشی از حاملگی، وجود علائم دیگری مانند اسهال که نشان دهنده پاتولوژیک بودن تهوع و استفراغ است و بروز هر گونه بیماری که علائم تهوع و استفراغ را ایجاد و یا تشدید کند و ختم بارداری می باشند.
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the intervention started from day 3 and continued until day 6. On day 3, the researcher, at first, cleaned both outer auricles using 75% alcohol and then the effective areas in controlling nausea and vomiting such as Point zero, stomach, Sympathetic Autonomic, Shen Men, and cardia were determined and the researcher placed a magnetic seed on each point and adhered the seeds using non-latex glue. The participants were then instructed by the researcher to press each spot three times a day (morning, noon, and night) and each time for at least 30 seconds. The same was true for the participants in the sham control group except that the points where these magnetic seeds were placed (e.g. the vision, knee, shoulder and eyes) had no effects on the nausea and vomiting.
the intervention started from day 3 and continued until day 6. On day 3, the researcher, at first, cleaned both outer auricles using 75% alcohol and then the effective areas in controlling nausea and vomiting such as Point zero, stomach, Sympathetic Autonomic, Shen Men, and cardia were determined and the researcher placed a magnetic seed on each point and adhered the seeds using non-latex glue. The participants were then instructed by the researcher to press each spot three times a day (morning, noon, and night) and each time for at least 30 seconds. The same was true for the participants in the sham control group except that the points where these magnetic seeds were placed (e.g. the vision, knee, shoulder and eyes) had no effects on the nausea and vomiting.
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در گروه مداخله پس از مراجعه در روز سوم توسط پژوهشگر، ابتدا هر دو لاله گوش خارجی با الکل 75 درصد تمیز شده و سپس نقاط مبدا ، معده ، سمپاتیک اتونومیک ، شن من ، قلب که بر کنترل تهوع و استفراغ موثر هستند تعیین و توسط پژوهشگر در هر نقطه یک دانه مغناطیسی گذاشته و با چسب مخصوص غیر لاتکس چسبانیده شد. سپس توسط پژوهشگر به بیماران آموزش داده شد که هر نقطه را سه بار در روز(صبح، ظهر و شب) و هر بار حداقل به مدت 30 ثانیه فشار بدهند. ت در گروه کنترل نیز به همین شکل عمل شد با این تفاوت که نقاطی که این دانه های مغناطیسی قرار می گرفتند هیچ گونه تاثیری بر تهوع و استفراغ ندارند انتخاب و دانه ها قرار داده شدند (نقاط بینایی، مفصل زانو، چشم و مفصل شانه).
در گروه مداخله پس از مراجعه در روز سوم توسط پژوهشگر، ابتدا هر دو لاله گوش خارجی با الکل 75 درصد تمیز شده و سپس نقاط مبدا ، معده ، سمپاتیک اتونومیک ، شن من ، قلب که بر کنترل تهوع و استفراغ موثر هستند تعیین و توسط پژوهشگر در هر نقطه یک دانه مغناطیسی گذاشته و با چسب مخصوص غیر لاتکس چسبانیده شد. سپس توسط پژوهشگر به بیماران آموزش داده شد که هر نقطه را سه بار در روز(صبح، ظهر و شب) و هر بار حداقل به مدت 30 ثانیه فشار بدهند. ت در گروه کنترل نیز به همین شکل عمل شد با این تفاوت که نقاطی که این دانه های مغناطیسی قرار می گرفتند هیچ گونه تاثیری بر تهوع و استفراغ ندارند انتخاب و دانه ها قرار داده شدند (نقاط بینایی، مفصل زانو، چشم و مفصل شانه).
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nausea and vomiting in pregnancy
nausea and vomiting in pregnancy
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تهوع و استفراغ بارداری
تهوع و استفراغ بارداری
General information
Single blinded
Double blinded
singldoubl
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1
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128
128
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2017-12-01, 1396/09/10
2017-12-01 00:00:00
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2018-10-01, 1397/07/09
2018-10-01 00:00:00
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2019-02-19, 1397/11/30
2019-02-19 00:00:00
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Closure of the study, the need for some modifications such as changing the study setting and blindness and also changing the name of the hospital
Closure of the study, the need for some modifications such as changing the study setting and blindness and also changing the name of the hospital
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اختتام این مطالعه و نیاز به بعضی از اصلاحات از قبیل تغییر مرکز انجام مطالعه و کور سازی می باشد وهمچنین تغییر اسم بیمارستان در گذر زمان می باشد
اختتام این مطالعه و نیاز به بعضی از اصلاحات از قبیل تغییر مرکز انجام مطالعه و کور سازی می باشد وهمچنین تغییر اسم بیمارستان در گذر زمان می باشد
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Mirza kuchak khan Hospital
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Arash Hospital
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Mirza kuchak khanArash Hospital
تعیین تاثیر طب فشاری گوش بر شدت تهوع و استفراغ در زنان باردار مبتلا به تهوع و استفراغ دوران بارداری مراجعه کننده به مرکز پره ناتال بیمارستان میرزا کوچک خان
تعیین تاثیر طب فشاری گوش بر شدت تهوع و استفراغ در زنان باردار مبتلا به تهوع و استفراغ دوران بارداری مراجعه کننده به بیمارستان آرش
تعیین تاثیر طب فشاری گوش بر شدت تهوع و استفراغ در زنان باردار مبتلا به تهوع و استفراغ دوران بارداری مراجعه کننده به مرکز پره ناتال بیمارستان میرزا کوچک خانآرش
mild to moderate nausea and vomiting according to Rhodes’ Standard Index
the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography
single pregnancy
mild to moderate nausea and vomiting according to Rhodes’ Standard Index the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography single pregnancy
داتشن تهوع و استفراغ خفیف تا متوسط بر اساس شاخص رودز
هفته 6 تا 16 بارداری بر اساس اولین روز آخرین قاعدگی و یا سونوگرافی
حاملگی تک قلویی
داتشن تهوع و استفراغ خفیف تا متوسط بر اساس شاخص رودز هفته 6 تا 16 بارداری بر اساس اولین روز آخرین قاعدگی و یا سونوگرافی حاملگی تک قلویی
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Randomized block design with the size of 4 was used for randomization. The random sequence was proposed by a statistical expert and through appropriate software. A total number of 32 blocks of four were prepared and then the samples were assigned to intervention and sham control groups
Randomized block design with the size of 4 was used for randomization. The random sequence was proposed by a statistical expert and through appropriate software. A total number of 32 blocks of four were prepared and then the samples were assigned to intervention and sham control groups
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به منظور تصادفی سازی از روش تصادفی سازی بلوکی به بلوک های 4 تایی استفاده شد. توالی این ها توسط استاد امار پیشنهاد شد و از نرم افزار مناسبی برای تهیه ان استفاده شد. تعداد کلی بلوک ها 32 تا بلوک 4 تا تشکیل شد.و بیماران در گروه مداخله و کنترل قرار گرفتند
به منظور تصادفی سازی از روش تصادفی سازی بلوکی به بلوک های 4 تایی استفاده شد. توالی این ها توسط استاد امار پیشنهاد شد و از نرم افزار مناسبی برای تهیه ان استفاده شد. تعداد کلی بلوک ها 32 تا بلوک 4 تا تشکیل شد.و بیماران در گروه مداخله و کنترل قرار گرفتند
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In order to observe the double-blindness of the study, sham points were used for patients in the sham control group so that individuals were unaware of which group they were assigned to. In addition, the statistics expert was unaware of the fact that which group was real and which were sham. Even those who were in charge of evaluation of the outcomes of the study were also unaware of the assigning of the individuals to real groups
In order to observe the double-blindness of the study, sham points were used for patients in the sham control group so that individuals were unaware of which group they were assigned to. In addition, the statistics expert was unaware of the fact that which group was real and which were sham. Even those who were in charge of evaluation of the outcomes of the study were also unaware of the assigning of the individuals to real groups
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به منظور انجام کورسازی دو سویه از گروه کنترل دروغین استفاده شد. بطوری که بیماران از اینکه در کدام گروه قرار داشتند بی اطلاع بودند. علاوه بر این متخصص اماری از گروه مداخله و کنترل بی اطلاع بود.
به منظور انجام کورسازی دو سویه از گروه کنترل دروغین استفاده شد. بطوری که بیماران از اینکه در کدام گروه قرار داشتند بی اطلاع بودند. علاوه بر این متخصص اماری از گروه مداخله و کنترل بی اطلاع بود.
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Recruitment centers
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Name of recruitment center - English: Prenatal center of Mirza Kuchak Khan Hospital
Name of recruitment center - Persian: مرکز پره ناتال بیمارستان میرزا کوچک خان
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Street address - English: First floor, Mirza Kuchak Khan Hospital, Ostad Nejatollahi St, Area 6, Tehran
Street address - Persian: خیابان استاد نجات الهی، بیمارستان میرزا کوچک خان،
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Prenatal center of Arash Hospital
Name of recruitment center - Persian: مرکز پره ناتال بیمارستان آرش
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Street address - English: Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
Street address - Persian: بزرگراه رسالت -بعد از اتوبان شهید باقری-خیابان شهید باغدارنیا(رشید شمالی)- نبش کوچه ۱۶۲ (شهید عبدالمجید)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1448634443
Phone: +98 21 7788 3284
Fax:
Email: hosp_arash@tums.ac.ir
Web page address:
Name of recruitment center - English: Prenatal center of Mirza Kuchak KhanArash Hospital Name of recruitment center - Persian: مرکز پره ناتال بیمارستان میرزا کوچک خانآرش Full name of responsible person - English: Mohamad Eghbali Full name of responsible person - Persian: محمد اقبالی Street address - English: First floorEastern 162th St.,Baghdarnia st.,Resalat Highway, Mirza Kuchak Khan Hospital, Ostad Nejatollahi St, Area 6Tehranpars, Tehran ,Iran. Street address - Persian: بزرگراه رسالت -بعد از اتوبان شهید باقری-خیابان استاد نجات الهی، بیمارستان میرزا کوچک خان،شهید باغدارنیا(رشید شمالی)- نبش کوچه ۱۶۲ (شهید عبدالمجید) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1448634443 Phone: +98 21 7788 3284 Fax: Email: hosp_arash@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Doctor Masood Younesian - Vice President of Research and Technology
Full name of responsible person - Persian: دکتر مسعود یونسیان-معاون تحقیقات و فناوری دانشگاه
Street address - English: Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz St, Tehran
Street address - Persian: تهران، خیابان کشاورز، خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، طبقه ششم
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Doctor Masood Younesian - Vice President of Research and Technology
Full name of responsible person - Persian: دکتر مسعود یونسیان-معاون تحقیقات و فناوری دانشگاه
Street address - English: Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz St, Tehran
Street address - Persian: تهران، خیابان کشاورز، خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، طبقه ششم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6649 2271
Fax:
Email: tums_edu@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Doctor Masood Younesian - Vice President of Research and Technology Full name of responsible person - Persian: دکتر مسعود یونسیان-معاون تحقیقات و فناوری دانشگاه Street address - English: Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz St, Tehran Street address - Persian: تهران، خیابان کشاورز، خیابان قدس، ساختمان مرکزی دانشگاه علوم پزشکی تهران، طبقه ششم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 6649 2271 Fax: Email: tums_edu@tums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Position - English: PhD Student in nursing
Position - Persian: دانشجوی دکتری پرستاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: kodakyar Ave., daneshjo Blvd.,Evin
Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 22180083
Mobile: +98 915 966 4788
Fax:
Email: eghbali.msn@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Position - English: PhD Student in nursing
Position - Persian: دانشجوی دکتری پرستاری
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: kodakyar Ave., daneshjo Blvd.,Evin
Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 22180083
Mobile: +98 915 966 4788
Fax:
Email: eghbali.msn@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Mohamad Eghbali Full name of responsible person - Persian: محمد اقبالی Position - English: PhD Student in nursing Position - Persian: دانشجوی دکتری پرستاری Latest degree: phd Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: kodakyar Ave., daneshjo Blvd.,Evin Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 22180083 Mobile: +98 915 966 4788 Fax: Email: eghbali.msn@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Reza Negarandeh
Full name of responsible person - Persian: دکتر رضا نگارنده
Position - English: PhD in nursing
Position - Persian: دکتری پرستاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq
Street address - Persian: میدان توحید، خیابان نصرت، دانشکده پرستاری و مامایی، مرکز مراقبت های پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 66421685
Mobile:
Fax:
Email: rnegarandeh@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran University of Medical Science
Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Dr Reza Negarandeh
Full name of responsible person - Persian: دکتر رضا نگارنده
Position - English: PhD in nursing
Position - Persian: دکتری پرستاری
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq
Street address - Persian: میدان توحید، خیابان نصرت، دانشکده پرستاری و مامایی، مرکز مراقبت های پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1419733171
Phone: +98 66421685
Mobile: +98 912 618 8175
Fax:
Email: rnegarandeh@tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran University of Medical Science Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران Full name of responsible person - English: Dr Reza Negarandeh Full name of responsible person - Persian: دکتر رضا نگارنده Position - English: PhD in nursing Position - Persian: دکتری پرستاری Latest degree: phd Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq Street address - Persian: میدان توحید، خیابان نصرت، دانشکده پرستاری و مامایی، مرکز مراقبت های پرستاری و مامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1419733171 Phone: +98 66421685 Mobile: +98 912 618 8175 Fax: Email: rnegarandeh@tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Position - English: PhD Student in nursing
Position - Persian: دانشجوی دکتری پرستاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: kodakyar Ave., daneshjo Blvd.,Evin
Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: +98 915 966 4788
Fax:
Email: eghbali.msn@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohamad Eghbali
Full name of responsible person - Persian: محمد اقبالی
Position - English: PhD Student in nursing
Position - Persian: دانشجوی دکتری پرستاری
Latest degree: phd
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: kodakyar Ave., daneshjo Blvd.,Evin
Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 21 2218 0083
Mobile: +98 915 966 4788
Fax:
Email: eghbali.msn@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Mohamad Eghbali Full name of responsible person - Persian: محمد اقبالی Position - English: PhD Student in nursing Position - Persian: دانشجوی دکتری پرستاری Latest degree: phd Area of specialty/work: 027 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: kodakyar Ave., daneshjo Blvd.,Evin Street address - Persian: اوین، بلوار دانشجو، خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴ Phone: 00+98 21 2218 0083 Mobile: +98 915 966 4788 Fax: Email: eghbali.msn@gmail.com Web page address:
Sharing plan
no
no
no
no
no
no
no
no
no
no
no
no
no
no
empty
No decision has been made by the team at this time.
No decision has been made by the team at this time.
empty
در حال حاضر تصمیمی در این خصوص از طرف تیم گرفته نشده است.
در حال حاضر تصمیمی در این خصوص از طرف تیم گرفته نشده است.
Protocol summary
Study aim
to evaluate the effect of auriculotherapy on nausea and vomiting during pregnancy.
Design
This study is a double blind randomized controlled clinical trial with parallel groups. sample of 64 individuals for each group was suggested accordingly
Settings and conduct
The research setting was the prenatal center of Arash Women’s Hospital affiliated to Tehran University of Medical Sciences. patient and a statistics expert was blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria include mild to moderate nausea and vomiting according to Rhodes’ Standard Index; women of 18 to 35 years old; in the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography; single pregnancy; and literacy.
While exclusion criteria include severe nausea and vomiting; hyperemesis gravidarum during pregnancy; other symptoms such as diarrhea indicating pathologic nature of nausea and vomiting; and any other disease that causes or aggravates the symptoms of nausea and vomiting and results in abortion.
Intervention groups
the intervention started from day 3 and continued until day 6. On day 3, the researcher, at first, cleaned both outer auricles using 75% alcohol and then the effective areas in controlling nausea and vomiting such as Point zero, stomach, Sympathetic Autonomic, Shen Men, and cardia were determined and the researcher placed a magnetic seed on each point and adhered the seeds using non-latex glue. The participants were then instructed by the researcher to press each spot three times a day (morning, noon, and night) and each time for at least 30 seconds. The same was true for the participants in the sham control group except that the points where these magnetic seeds were placed (e.g. the vision, knee, shoulder and eyes) had no effects on the nausea and vomiting.
Main outcome variables
nausea and vomiting in pregnancy
General information
Reason for update
Closure of the study, the need for some modifications such as changing the study setting and blindness and also changing the name of the hospital
Acronym
IRCT registration information
IRCT registration number:IRCT2015061415649N3
Registration date:2015-08-19, 1394/05/28
Registration timing:prospective
Last update:2020-01-29, 1398/11/09
Update count:1
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Mohammad Eghbali
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5242 1257
Email address
m-eghbali@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2017-12-01, 1396/09/10
Actual recruitment end date
2018-10-01, 1397/07/09
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Determining the effect of auricular acupressure on severity of nausea and vomiting in pregnancy among pregnant women referred to prenatal center of Arash Hospital
Public title
The effect of auricular acupressure on nausea and vomiting among pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
mild to moderate nausea and vomiting according to Rhodes’ Standard Index
the 6th to 16th week of pregnancy based on the first day of last menstrual period or sonography
single pregnancy
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design with the size of 4 was used for randomization. The random sequence was proposed by a statistical expert and through appropriate software. A total number of 32 blocks of four were prepared and then the samples were assigned to intervention and sham control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe the double-blindness of the study, sham points were used for patients in the sham control group so that individuals were unaware of which group they were assigned to. In addition, the statistics expert was unaware of the fact that which group was real and which were sham. Even those who were in charge of evaluation of the outcomes of the study were also unaware of the assigning of the individuals to real groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2015-06-25, 1394/04/04
Ethics committee reference number
IR.TUMS.REC.1394.278
Health conditions studied
1
Description of health condition studied
Nausea & vomiting in pregnancy
ICD-10 code
O21.9
ICD-10 code description
تهوع و استفراغ بارداری
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Every night for 6 days
Method of measurement
Rhodes index
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the magnetic seeds with a special adhesive latex will be attached in five effective points of ears for controlling the nausea and vomiting. Then patient will be asked for making pressure on each points for at least 30 seconds, three times a day
Category
Treatment - Other
2
Description
in the control group will be acted the same, but non effective points on nausea and vomiting will be used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal center of Arash Hospital
Full name of responsible person
Mohamad Eghbali
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1448634443
Phone
+98 21 7788 3284
Email
hosp_arash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Younesian - Vice President of Research and Technology
Street address
Sixth Floor, Central Building of Tehran University of Medical Sciences, Qods St, Keshavarz St, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.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, Tehran 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohamad Eghbali
Position
PhD Student in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 22180083
Fax
Email
eghbali.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Reza Negarandeh
Position
PhD in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 66421685
Fax
Email
rnegarandeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohamad Eghbali
Position
PhD Student in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
Email
eghbali.msn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No decision has been made by the team at this time.