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Protocol summary
Determining the effect of acupressure of BL25 points on the intensity of active phase pain and the outcome of childbirth in primiparous women referred to Imam Khomeini Hospital in Bandar-e Torkman in 1402-1403.
Determining the effect of acupressure of BL25 points on the intensity of active phase pain and the outcome of childbirth in pregnant women referred to Imam Ali Hospital in Amol in 1402-1403.
Determining the effect of acupressure of BL25 points on the intensity of active phase pain and the outcome of childbirth in primiparouspregnant women referred to Imam KhomeiniAli Hospital in Bandar-e TorkmanAmol in 1402-1403.
تعيين تاثير طب فشاری نقاط BL25 بر شدت درد فاز فعال و پیامد زايمان در زنان نخست زاي مراجعه كننده به بيمارستان امام خمینی شهر بندر ترکمن در سال 1403-1402
تعيين تاثير طب فشاری نقاط BL25 بر شدت درد فاز فعال و پیامد زايمان زنان باردار مراجعه كننده به بيمارستان امام علی شهر آمل در سال 1403-1402
تعيين تاثير طب فشاری نقاط BL25 بر شدت درد فاز فعال و پیامد زايمان در زنان نخست زايباردار مراجعه كننده به بيمارستان امام خمینیعلی شهر بندر ترکمنآمل در سال 1403-1402
The research environment is the maternity ward of Imam Khomeini Hospital in Bandar-e Torkman. The sampling method is purpose-based sampling, the primiparous women referred for childbirth, if they are willing to participate in the study and have the characteristics of the research units, are considered as the research sample. Before the beginning of the sampling, with the help of the software, the random order of assigning people to the groups is specified by the supervisor from 1 to 90 and is placed inside the envelope. On the envelope, the number related to the sequence of the person's entry into the research is written, but the researcher will not know the type of group of people before starting the intervention.
The research environment is the maternity ward of Imam Ali Hospital in Amol. The sampling method is purpose-based sampling, the pregnant women referred for childbirth, if they are willing to participate in the study and have the characteristics of the research units, are considered as the research sample. Before the beginning of the sampling, with the help of the software, the random order of assigning people to the groups is specified by the supervisor from 1 to 90 and is placed inside the envelope. On the envelope, the number related to the sequence of the person's entry into the research is written, but the researcher will not know the type of group of people before starting the intervention.
The research environment is the maternity ward of Imam KhomeiniAli Hospital in Bandar-e TorkmanAmol. The sampling method is purpose-based sampling, the primiparouspregnant women referred for childbirth, if they are willing to participate in the study and have the characteristics of the research units, are considered as the research sample. Before the beginning of the sampling, with the help of the software, the random order of assigning people to the groups is specified by the supervisor from 1 to 90 and is placed inside the envelope. On the envelope, the number related to the sequence of the person's entry into the research is written, but the researcher will not know the type of group of people before starting the intervention.
محیط پژوهش بلوک زایمانی بیمارستان امام خمینی شهر بندر ترکمن می باشد. روش نمونه گیری به صورت نمونه گیری مبتنی بر هدف می باشد، خانم های نخست زای مراجعه کننده برای زایمان در صورت تمایل به شرکت در مطالعه و دارا بودن مشخصات واحدهای پژوهش، به عنوان نمونه پژوهش در نظر گرفته می شوند. قبل از آغاز نمونه گیری با کمک نرم افزار ترتیب توالی تصادفی انتساب افراد به گروه ها توسط استاد راهنما از یک تا 90 مشخص شده و در داخل پاکت قرار می گیرد. روی پاکت عدد مربوط به توالی ورود فرد به پژوهش قید می شود اما پژوهشگر قبل از آغاز مداخله از نوع گروه از افراد بی اطلاع خواهد بود.
محیط پژوهش بلوک زایمانی بیمارستان امام علی شهر آمل می باشد. روش نمونه گیری به صورت نمونه گیری مبتنی بر هدف می باشد، زنان باردار مراجعه کننده برای زایمان در صورت تمایل به شرکت در مطالعه و دارا بودن مشخصات واحدهای پژوهش، به عنوان نمونه پژوهش در نظر گرفته می شوند. قبل از آغاز نمونه گیری با کمک نرم افزار ترتیب توالی تصادفی انتساب افراد به گروه ها توسط استاد راهنما از یک تا 90 مشخص شده و در داخل پاکت قرار می گیرد. روی پاکت عدد مربوط به توالی ورود فرد به پژوهش قید می شود اما پژوهشگر قبل از آغاز مداخله از نوع گروه از افراد بی اطلاع خواهد بود.
محیط پژوهش بلوک زایمانی بیمارستان امام خمینیعلی شهر بندر ترکمنآمل می باشد. روش نمونه گیری به صورت نمونه گیری مبتنی بر هدف می باشد، خانم های نخست زایزنان باردار مراجعه کننده برای زایمان در صورت تمایل به شرکت در مطالعه و دارا بودن مشخصات واحدهای پژوهش، به عنوان نمونه پژوهش در نظر گرفته می شوند. قبل از آغاز نمونه گیری با کمک نرم افزار ترتیب توالی تصادفی انتساب افراد به گروه ها توسط استاد راهنما از یک تا 90 مشخص شده و در داخل پاکت قرار می گیرد. روی پاکت عدد مربوط به توالی ورود فرد به پژوهش قید می شود اما پژوهشگر قبل از آغاز مداخله از نوع گروه از افراد بی اطلاع خواهد بود.
Entry conditions: term primiparous singleton pregnancy with vertex presentation, mother's absence of chronic disease and pregnancy complications. Conditions of non-entry: the mother's unwillingness to continue participating in the study and the occurrence of adverse side effects
Entry conditions: term singleton pregnancy with vertex presentation, mother's absence of chronic disease and pregnancy complications. Conditions of non-entry: the mother's unwillingness to continue participating in the study and the occurrence of adverse side effects
Entry conditions: term primiparous singleton pregnancy with vertex presentation, mother's absence of chronic disease and pregnancy complications. Conditions of non-entry: the mother's unwillingness to continue participating in the study and the occurrence of adverse side effects
شرایط ورود: حاملگی تک قلویی نخست زا ترم با نمایش ورتکس، عدم ابتلا مادر به بیماری مزمن و عوارض حاملگی
شرایط عدم ورود: عدم تمایل مادر به ادامه شرکت در مطالعه و بروز عوارض نامطلوب
شرایط ورود: حاملگی تک قلویی ترم با نمایش ورتکس، عدم ابتلا مادر به بیماری مزمن و عوارض حاملگی
شرایط عدم ورود: عدم تمایل مادر به ادامه شرکت در مطالعه و بروز عوارض نامطلوب
شرایط ورود: حاملگی تک قلویی نخست زا ترم با نمایش ورتکس، عدم ابتلا مادر به بیماری مزمن و عوارض حاملگی شرایط عدم ورود: عدم تمایل مادر به ادامه شرکت در مطالعه و بروز عوارض نامطلوب
Pain intensity of the first stage and the outcome of childbirth in primiparous women.
Pain intensity of the first stage and the outcome of childbirth in pregnant women.
Pain intensity of the first stage and the outcome of childbirth in primiparouspregnant women.
شدت درد مرحله اول و پیامد زایمان در زنان نخست زا
شدت درد مرحله اول و پیامد زایمان در زنان باردار
شدت درد مرحله اول و پیامد زایمان در زنان نخست زاباردار
General information
2024-04-12, 1403/01/24
2024-07-04, 1403/04/14
2024-07-04-12 00:00:00
2024-09-20, 1403/06/30
2024-11-19, 1403/08/29
2024-0911-2019 00:00:00
Modification of the primary variable part of the time section field: the measurement of pain intensity before the intervention and 10 minutes after the intervention and immediately after the intervention was changed to the measurement of pain intensity before the intervention and immediately after the intervention.
Secondary variable section: The field of secondary variables was added.
Due to the delay in the expected start of sampling, the start date was changed.
Modification of the section responsible for scientific accountability was changed from the name of the student to the supervisor.
Modification of the sponsoring officer section was changed from the name of the student to the official of the university.
Correction of the address of the patient care center and the place to receive the code of ethics
Modification of the primary variable part of the time section field: the measurement of pain intensity before the intervention and 10 minutes after the intervention and immediately after the intervention was changed to the measurement of pain intensity before the intervention and immediately after the intervention.
Secondary variable section: The field of secondary variables was added.
Due to the delay in the expected start of sampling, the start date was changed.
Modification of the section responsible for scientific accountability was changed from the name of the student to the supervisor.
Modification of the sponsoring officer section was changed from the name of the student to the official of the university.
Correction of the address of the patient care center and the place to receive the code of ethics
/Change the title from primiparous women to pregnant women
/Adding pregnant women (do not have more than one vaginal delivery) In the entry criteria section
/Changing the sampling site hospital
/Sampling has not started yet and the expected date has changed.
Modification of the primary variable part of the time section field: the measurement of pain intensity before the intervention and 10 minutes after the intervention and immediately after the intervention was changed to the measurement of pain intensity before the intervention and immediately after the intervention. Secondary variable section: The field of secondary variables was added. Due to the delay in the expected start of sampling, the start date was changed. Modification of the section responsible for scientific accountability was changed from the name of the student to the supervisor. Modification of the sponsoring officer section was changed from the name of the student to the official of the university. Correction of the address of the patient care center and the place to receive the code of ethics /Change the title from primiparous women to pregnant women /Adding pregnant women (do not have more than one vaginal delivery) In the entry criteria section /Changing the sampling site hospital /Sampling has not started yet and the expected date has changed.
اصلاح بخش متغیر اولیه فیلد مقطع زمانی: اندازه گیری شدت درد از قبل مداخله و 10 دقیقه پس از مداخله و بلافاصله بعد مداخله به اندازه گیری شدت درد قبل مداخله و بلافاصله بعد مداخله تغییر یافت.
بخش متغیر ثانویه: فیلد متغیر های ثانویه اضافه شد.
با توجه به تاخیر افتادن زمان مورد انتظار شروع نمونه گیری، تاریخ شروع تغییر کرد.
اصلاح بخش مسئول پاسخگویی علمی از نام دانشجو به استاد راهنما تغییر کرد.
اصلاح بخش مسئول حمایت کننده مالی از نام دانشجو به مسئول دانشگاه تغییر کرد.
اصلاح بخش آدرس مرکز بیمارگیری و محل دریافت کد اخلاق
اصلاح بخش متغیر اولیه فیلد مقطع زمانی: اندازه گیری شدت درد از قبل مداخله و 10 دقیقه پس از مداخله و بلافاصله بعد مداخله به اندازه گیری شدت درد قبل مداخله و بلافاصله بعد مداخله تغییر یافت.
بخش متغیر ثانویه: فیلد متغیر های ثانویه اضافه شد.
با توجه به تاخیر افتادن زمان مورد انتظار شروع نمونه گیری، تاریخ شروع تغییر کرد.
اصلاح بخش مسئول پاسخگویی علمی از نام دانشجو به استاد راهنما تغییر کرد.
اصلاح بخش مسئول حمایت کننده مالی از نام دانشجو به مسئول دانشگاه تغییر کرد.
اصلاح بخش آدرس مرکز بیمارگیری و محل دریافت کد اخلاق
/اصلاح عنوان از زنان نخست زا به زنان باردار
/افزودن زنان باردار( بیشتر از یک زایمان واژینال نداشته باشد) در بخش معیار ورود
/تغییر بیمارستان محل نمونه گیری
/نمونه گیری هنوز شروع نشده و تاریخ موردنظر تغییر کرده است.
اصلاح بخش متغیر اولیه فیلد مقطع زمانی: اندازه گیری شدت درد از قبل مداخله و 10 دقیقه پس از مداخله و بلافاصله بعد مداخله به اندازه گیری شدت درد قبل مداخله و بلافاصله بعد مداخله تغییر یافت. بخش متغیر ثانویه: فیلد متغیر های ثانویه اضافه شد. با توجه به تاخیر افتادن زمان مورد انتظار شروع نمونه گیری، تاریخ شروع تغییر کرد. اصلاح بخش مسئول پاسخگویی علمی از نام دانشجو به استاد راهنما تغییر کرد. اصلاح بخش مسئول حمایت کننده مالی از نام دانشجو به مسئول دانشگاه تغییر کرد. اصلاح بخش آدرس مرکز بیمارگیری و محل دریافت کد اخلاق /اصلاح عنوان از زنان نخست زا به زنان باردار /افزودن زنان باردار( بیشتر از یک زایمان واژینال نداشته باشد) در بخش معیار ورود /تغییر بیمارستان محل نمونه گیری /نمونه گیری هنوز شروع نشده و تاریخ موردنظر تغییر کرده است.
The Effect of BL25 Acupressure on Pain Intensity in the First Stage of Labor, And Birth outcome in Primiparous Women
The Effect of BL25 Acupressure on Pain Intensity in the First Stage of Labor, And Birth outcome in Pregnant Women
The Effect of BL25 Acupressure on Pain Intensity in the First Stage of Labor, And Birth outcome in PrimiparousPregnant Women
بررسی تاثير طب فشاری نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان نخست زا
بررسی تاثير طب فشاری نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان باردار
بررسی تاثير طب فشاری نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان نخست زاباردار
Primiparous
Do not have a history of more than one miscarriage
Gestational age between 37-42 weeks (according to ultrasound before 12 weeks or LMP)
Single ton , Vertex Presentation
Dilatation 4-5 cm (at the beginning of the active phase of labor)
The presence of at least three contractions in 10 minutes
The appropriateness of the pelvic position
Failure to use analgesic drugs (chemical or herbal) in the last 8 hours
Absence of chronic disease such as cardiovascular disease, kidney disease, joint rheumatism and epilepsy
Not suffering from a known mental illness
No history of unfortunate events, such as the death of a spouse or a close relative during pregnancy
Absence of complications during pregnancy such as pre-eclampsia, chorioamnionitis, etc.
Absence of obstetric complications (such as decollement, abnormal fetal heart rate, etc.) upon entering the study
pregnant women (do not have more than one vaginal delivery)
Do not have a history of more than one miscarriage
Gestational age between 37-42 weeks (according to ultrasound before 12 weeks or LMP)
Single ton , Vertex Presentation
Dilatation 4-5 cm (at the beginning of the active phase of labor)
The presence of at least three contractions in 10 minutes
The appropriateness of the pelvic position
Failure to use analgesic drugs (chemical or herbal) in the last 8 hours
Absence of chronic disease such as cardiovascular disease, kidney disease, joint rheumatism and epilepsy
Not suffering from a known mental illness
No history of unfortunate events, such as the death of a spouse or a close relative during pregnancy
Absence of complications during pregnancy such as pre-eclampsia, chorioamnionitis, etc.
Absence of obstetric complications (such as decollement, abnormal fetal heart rate, etc.) upon entering the study
Primiparouspregnant women (do not have more than one vaginal delivery) Do not have a history of more than one miscarriage Gestational age between 37-42 weeks (according to ultrasound before 12 weeks or LMP) Single ton , Vertex Presentation Dilatation 4-5 cm (at the beginning of the active phase of labor) The presence of at least three contractions in 10 minutes The appropriateness of the pelvic position Failure to use analgesic drugs (chemical or herbal) in the last 8 hours Absence of chronic disease such as cardiovascular disease, kidney disease, joint rheumatism and epilepsy Not suffering from a known mental illness No history of unfortunate events, such as the death of a spouse or a close relative during pregnancy Absence of complications during pregnancy such as pre-eclampsia, chorioamnionitis, etc. Absence of obstetric complications (such as decollement, abnormal fetal heart rate, etc.) upon entering the study
نخست زا
سابقه بیشتر از یک سقط نداشته باشد
سن حاملگي بین 37-42 هفته(طبق سونوگرافی قبل از 12 هفته یا LMP)
تك قلو، نمايش ورتكس
ديلاتاسيون 5-4 سانتي متر(در شروع فاز فعال زایمان باشد)
وجود حداقل سه انقباض در 10 دقیقه
مناسب بودن وضعیت لگن
عدم استفاده از داروهای آنالژزیک (شیمیایی یا گیاهی) در 8 ساعت گذشته
عدم ابتلا به بيماري مزمن مثل بيماري قلبي- عروقي، بيماري كليه، روماتيسم مفصلي و صرع
عدم ابتلا به بیماری شناخته شده روانی
عدم سابقه ی حوادث ناگواری مثل فوت همسر یا یکی از نزدیکان در دوران بارداری
عدم ابتلا به عوارض دوران بارداري مثل پره اكلامپسي، كوريوآمنيونيت و...
عدم ابتلا به عوارض مامایی(مثل دکولمان، ضربان غیر طبیعی قلب جنین و...) در بدو ورود به مطالعه
زنان باردار( بیشتر از یک زایمان واژینال نداشته باشد)
سابقه بیشتر از یک سقط نداشته باشد
سن حاملگي بین 37-42 هفته(طبق سونوگرافی قبل از 12 هفته یا LMP)
تك قلو، نمايش ورتكس
ديلاتاسيون 5-4 سانتي متر(در شروع فاز فعال زایمان باشد)
وجود حداقل سه انقباض در 10 دقیقه
مناسب بودن وضعیت لگن
عدم استفاده از داروهای آنالژزیک (شیمیایی یا گیاهی) در 8 ساعت گذشته
عدم ابتلا به بيماري مزمن مثل بيماري قلبي- عروقي، بيماري كليه، روماتيسم مفصلي و صرع
عدم ابتلا به بیماری شناخته شده روانی
عدم سابقه ی حوادث ناگواری مثل فوت همسر یا یکی از نزدیکان در دوران بارداری
عدم ابتلا به عوارض دوران بارداري مثل پره اكلامپسي، كوريوآمنيونيت و...
عدم ابتلا به عوارض مامایی(مثل دکولمان، ضربان غیر طبیعی قلب جنین و...) در بدو ورود به مطالعه
نخست زازنان باردار( بیشتر از یک زایمان واژینال نداشته باشد) سابقه بیشتر از یک سقط نداشته باشد سن حاملگي بین 37-42 هفته(طبق سونوگرافی قبل از 12 هفته یا LMP) تك قلو، نمايش ورتكس ديلاتاسيون 5-4 سانتي متر(در شروع فاز فعال زایمان باشد) وجود حداقل سه انقباض در 10 دقیقه مناسب بودن وضعیت لگن عدم استفاده از داروهای آنالژزیک (شیمیایی یا گیاهی) در 8 ساعت گذشته عدم ابتلا به بيماري مزمن مثل بيماري قلبي- عروقي، بيماري كليه، روماتيسم مفصلي و صرع عدم ابتلا به بیماری شناخته شده روانی عدم سابقه ی حوادث ناگواری مثل فوت همسر یا یکی از نزدیکان در دوران بارداری عدم ابتلا به عوارض دوران بارداري مثل پره اكلامپسي، كوريوآمنيونيت و... عدم ابتلا به عوارض مامایی(مثل دکولمان، ضربان غیر طبیعی قلب جنین و...) در بدو ورود به مطالعه
Health conditions studied
#1
The effect of BL25 acupressure on pain intensity in the first stage of labor, and birth outcome in primiparous women
The effect of BL25 acupressure on pain intensity in the first stage of labor, and birth outcome in pregnant women
The effect of BL25 acupressure on pain intensity in the first stage of labor, and birth outcome in primiparouspregnant women
بررسی تاثير طب فشاري نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان نخست زا
بررسی تاثير طب فشاري نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان باردار
بررسی تاثير طب فشاري نقطه BL25 بر شدت درد مرحله اول و پیامد زایمان در زنان نخست زاباردار
Primary outcomes
#1
The pain intensity of the first stage of labor in primiparous women is measured by a numerical pain rating scale. The pain intensity scale is a number between zero and 10, where zero indicates no pain and 10 indicates the most severe pain.
The pain intensity of the first stage of labor in pregnant women is measured by a numerical pain rating scale. The pain intensity scale is a number between zero and 10, where zero indicates no pain and 10 indicates the most severe pain.
The pain intensity of the first stage of labor in primiparouspregnant women is measured by a numerical pain rating scale. The pain intensity scale is a number between zero and 10, where zero indicates no pain and 10 indicates the most severe pain.
شدت درد مرحله اول زایمان در زنان نخست زا که با مقياس درجه بندی عددی درد سنجیده می شود. مقیاس شدت درد عددی بین صفر تا 10 است که صفر نشان دهنده بدون درد و 10 نشان دهنده شدیدترین درد است.
شدت درد مرحله اول زایمان در زنان باردار که با مقياس درجه بندی عددی درد سنجیده می شود. مقیاس شدت درد عددی بین صفر تا 10 است که صفر نشان دهنده بدون درد و 10 نشان دهنده شدیدترین درد است.
شدت درد مرحله اول زایمان در زنان نخست زاباردار که با مقياس درجه بندی عددی درد سنجیده می شود. مقیاس شدت درد عددی بین صفر تا 10 است که صفر نشان دهنده بدون درد و 10 نشان دهنده شدیدترین درد است.
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Street address - English: Imam Khomeini Hospital, The end of Shahid Arkhi Blvd
Street address - Persian: انتهای بلوار شهید آرخی، بیمارستان امام خمینی
City - English: Bandare- Torkman
City - Persian: بندرترکمن
Province: Golestan
Country: Iran (Islamic Republic of)
Postal code: 4891674811
Phone: +98 17 3442 4091
Fax:
Email: mahdieh-aly@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Imam Ali Hospital
Name of recruitment center - Persian: بیمارستان امام علی
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Street address - English: Imam Ali Blvd. - Amol Chamestan
Street address - Persian: بلوار امام علی - آمل چمستان
City - English: Amol
City - Persian: آمل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4815733971
Phone: +98 11 4426 4661
Fax:
Email: mahdieh-aly@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Imam KhomeiniAli Hospital Name of recruitment center - Persian: بیمارستان امام خمینیعلی Full name of responsible person - English: Mahdieh Aly Full name of responsible person - Persian: مهدیه عالی Street address - English: Imam Khomeini Hospital, The end of Shahid ArkhiAli Blvd. - Amol Chamestan Street address - Persian: انتهای بلوار شهید آرخی، بیمارستان امام خمینیعلی - آمل چمستان City - English: Bandare- TorkmanAmol City - Persian: بندرترکمنآمل Province: GolestanMazandaran Country: Iran (Islamic Republic of) Postal code: 48916748114815733971 Phone: +98 17 3442 409111 4426 4661 Fax: Email: mahdieh-aly@sbmu.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of acupressure of BL25 points on the intensity of active phase pain and the outcome of childbirth in pregnant women referred to Imam Ali Hospital in Amol in 1402-1403.
Design
Clinical trial with control and sham groups, with parallel groups, single-blind, randomized, on 90 patients. The randomization will be done using the Random Allocation Software.
Settings and conduct
The research environment is the maternity ward of Imam Ali Hospital in Amol. The sampling method is purpose-based sampling, the pregnant women referred for childbirth, if they are willing to participate in the study and have the characteristics of the research units, are considered as the research sample. Before the beginning of the sampling, with the help of the software, the random order of assigning people to the groups is specified by the supervisor from 1 to 90 and is placed inside the envelope. On the envelope, the number related to the sequence of the person's entry into the research is written, but the researcher will not know the type of group of people before starting the intervention.
Participants/Inclusion and exclusion criteria
Entry conditions: term singleton pregnancy with vertex presentation, mother's absence of chronic disease and pregnancy complications. Conditions of non-entry: the mother's unwillingness to continue participating in the study and the occurrence of adverse side effects
Intervention groups
Intervention in the acupressure group is performed on BL25 and Sham points for 20 minutes during uterine contractions in three stages (dilatation of 4-5, 6-7, and 8-10 cm) and a total of 60 minutes. The control group will receive all the care of the intervention groups, except acupressure.
Main outcome variables
Pain intensity of the first stage and the outcome of childbirth in pregnant women.
General information
Reason for update
Modification of the primary variable part of the time section field: the measurement of pain intensity before the intervention and 10 minutes after the intervention and immediately after the intervention was changed to the measurement of pain intensity before the intervention and immediately after the intervention.
Secondary variable section: The field of secondary variables was added.
Due to the delay in the expected start of sampling, the start date was changed.
Modification of the section responsible for scientific accountability was changed from the name of the student to the supervisor.
Modification of the sponsoring officer section was changed from the name of the student to the official of the university.
Correction of the address of the patient care center and the place to receive the code of ethics
/Change the title from primiparous women to pregnant women
/Adding pregnant women (do not have more than one vaginal delivery) In the entry criteria section
/Changing the sampling site hospital
/Sampling has not started yet and the expected date has changed.
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060761N1
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:2
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
Mahdieh Aly
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4245 0274
Email address
mahdieh-aly@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-04, 1403/04/14
Expected recruitment end date
2024-11-19, 1403/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of BL25 Acupressure on Pain Intensity in the First Stage of Labor, And Birth outcome in Pregnant Women
Public title
The Effect of Acupressure on Pain Intensity in the First Stage of Labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women (do not have more than one vaginal delivery)
Do not have a history of more than one miscarriage
Gestational age between 37-42 weeks (according to ultrasound before 12 weeks or LMP)
Single ton , Vertex Presentation
Dilatation 4-5 cm (at the beginning of the active phase of labor)
The presence of at least three contractions in 10 minutes
The appropriateness of the pelvic position
Failure to use analgesic drugs (chemical or herbal) in the last 8 hours
Absence of chronic disease such as cardiovascular disease, kidney disease, joint rheumatism and epilepsy
Not suffering from a known mental illness
No history of unfortunate events, such as the death of a spouse or a close relative during pregnancy
Absence of complications during pregnancy such as pre-eclampsia, chorioamnionitis, etc.
Absence of obstetric complications (such as decollement, abnormal fetal heart rate, etc.) upon entering the study
Exclusion criteria:
Mother's unwillingness to continue participating in the study
Emergency caesarean section (after registration)
Occurrence of adverse outcomes (placental detachment, fetal distress, lack of progress in labor) (after registration)
Use of other non-pharmacological pain reduction methods (after registration)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Agreeable and eligible people will be selected to enter the study and after giving sufficient explanations about the goals and groups, written consent will be obtained from the samples. Then, randomly, people will be placed in three acupressure groups of BL25 points, Sham (placebo) acupressure points, and control. Random Allocation Software will be used to assign people to groups randomly. In this way, before the beginning of sampling with the help of the software, the order of the random sequence of assigning people to groups is determined by the supervisor from 1 to 90 and placed inside the envelope. On the envelope, the number related to the sequence of the person entering the research is written, but the researcher will not know the type of group of people before the intervention. After assigning people to groups, the envelope is opened and the type of research unit group is determined for the researcher. The research units will also be informed that they will be in the control or intervention group, but they will not be informed about whether they are in the BL25 or Sham acupressure group. Also, these numbers are recorded as codes on the observation and examination checklist and the information form of the research units so that the type of people's group is hidden during data entry into SPSS.
Blinding (investigator's opinion)
Single blinded
Blinding description
Agreeable and eligible people will be selected to enter the study and after giving sufficient explanations about the goals and groups, written consent will be obtained from the samples. Then, randomly, people will be placed in three acupressure groups of BL25 points, Sham (placebo) acupressure points, and control. Random Allocation Software will be used to assign people to groups randomly. In this way, before the beginning of sampling with the help of the software, the order of the random sequence of assigning people to groups is determined by the supervisor from 1 to 90 and placed inside the envelope. On the envelope, the number related to the sequence of the person entering the research is written, but the researcher will not know the type of group of people before the intervention. After assigning people to groups, the envelope is opened and the type of research unit group is determined for the researcher. The research units will also be informed that they will be in the control or intervention group, but they will not be informed about whether they are in the BL25 or Sham acupressure group. Also, these numbers are recorded as codes on the observation and examination checklist and the information form of the research units so that the type of people's group is hidden during data entry into SPSS.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery, Shahid Beheshti University
Street address
Shahid Beheshti School of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.194
Health conditions studied
1
Description of health condition studied
The effect of BL25 acupressure on pain intensity in the first stage of labor, and birth outcome in pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The pain intensity of the first stage of labor in pregnant women is measured by a numerical pain rating scale. The pain intensity scale is a number between zero and 10, where zero indicates no pain and 10 indicates the most severe pain.
Timepoint
Pain intensity is measured before the intervention, and immediately after the end of the intervention, in cervical dilatations of 4-5 cm, 6-7 cm and 8-10 cm.
Method of measurement
The pain intensity of the first stage of labor is measured with a numerical pain rating scale. The pain intensity scale is a number between 0 and 10, where 0 represents no pain and 10 represents the most severe pain.
Secondary outcomes
1
Description
The duration of the second stage of labor
Timepoint
From the completion of cervical dilatation until the complete expulsion of the fetus
Method of measurement
Observation and examination checklist
2
Description
The duration of the third stage of labor
Timepoint
From the exit of the fetus to the complete exit of the placenta and membranes
Method of measurement
Observation and examination checklist
3
Description
Need to resuscitate the baby
Timepoint
Postpartum
Method of measurement
Observation and examination checklist
4
Description
Apgar score of the baby
Timepoint
Postpartum
Method of measurement
Observation and examination checklist
5
Description
Bishop's score
Timepoint
In cervical dilatations of 4-5, 6-7 and 8-10 cm
Method of measurement
Observation and examination checklist
6
Description
Frequency of uterine contractions
Timepoint
In cervical dilatations of 4-5, 6-7 and 8-10 cm
Method of measurement
Observation and examination checklist
7
Description
Intensity of uterine contractions
Timepoint
In cervical dilatations of 4-5, 6-7 and 8-10 cm
Method of measurement
Observation and examination checklist
8
Description
Duration of uterine contractions
Timepoint
In cervical dilatations of 4-5, 6-7 and 8-10 cm
Method of measurement
Observation and examination checklist
9
Description
Need oxytocin
Timepoint
Postpartum
Method of measurement
Observation and examination checklist
10
Description
The need for pharmaceutical pain relief methods
Timepoint
Postpartum
Method of measurement
Observation and examination checklist
11
Description
Mother's satisfaction with pain relief
Timepoint
Postpartum
Method of measurement
Likert's questionnaire
Intervention groups
1
Description
Intervention group:BL25 acupressure group, intervention in BL25 acupressure points in dilatations of 4-5, 7-6 and 8-10 cm for 20 minutes and a total of 60 minutes, during uterine contractions, with the help of two thumbs of the researcher's hand. In order to prevent discomfort, deep and circular pressure is applied around the BL25 points until the researcher's nail changes color. In each dilatation, after the end of the contraction, the pressure will stop and start with the start of the next contraction. This action is repeated for 20 minutes during contractions. In addition, all the routine measures that are provided to the patients hospitalized in the delivery department, including FHR control, vaginal examination, administration and control of the first, second (except for delivery) and third stage of labor, assessment of labor problems, assessment of problems at birth And.... will also be done for all the people in the groups.
Category
N/A
2
Description
Intervention group: Acupressure of Sham (placebo) points, Acupressure for the Sham group was performed on points near BL25 (2.5 Cun outside of BL25) in exactly the same way as the acupressure group. In addition, all the routine measures that are provided to the patients hospitalized in the delivery department, including FHR control, vaginal examination, administration and control of the first, second (except for delivery) and third stage of labor, assessment of labor problems, assessment of problems at birth And.... will also be done for all the people in the groups.
Category
N/A
3
Description
Control group: In the control group, the researcher is present at the bedside of the pregnant mother, and all the measures that are performed for the control groups, including encouraging the continuation of breathing during contractions, without pressure on the BL25 and Sham points, are also performed for this group. Like the control groups, the researcher is with the people from the 4 cm dilatation of the cervix until the end of delivery at certain times and for the same period of time and provides them with emotional support. The intensity of pain in the intervals mentioned for this group will be measured by the numerical pain rating scale, just like the case groups.