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General information
2024-03-14, 1402/12/24
2024-04-12, 1403/01/24
2024-0304-1412 00:00:00
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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
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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
Primary outcomes
#1
Pain intensity is measured before the intervention, 10 minutes after the start of the intervention, and immediately after the end of the intervention, in cervical dilatations of 4-5 cm, 6-7 cm and 8-10 cm.
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.
Pain intensity is measured before the intervention, 10 minutes after the start of the intervention, and immediately after the end of the intervention, in cervical dilatations of 4-5 cm, 6-7 cm and 8-10 cm.
شدت درد قبل مداخله، 10 دقیقه پس از شروع مداخله، و بلافاصله پس از خاتمه مداخله، در دیلاتاسیون های سرویکس 4-5 سانتی متری، 6-7 سانتی متری و 8-10 سانتی متری اندازه گیری می شود.
شدت درد قبل مداخله و بلافاصله پس از خاتمه مداخله، در دیلاتاسیون های سرویکس 4-5 سانتی متری، 6-7 سانتی متری و 8-10 سانتی متری اندازه گیری می شود.
شدت درد قبل مداخله، 10 دقیقه پس از شروع مداخله، و بلافاصله پس از خاتمه مداخله، در دیلاتاسیون های سرویکس 4-5 سانتی متری، 6-7 سانتی متری و 8-10 سانتی متری اندازه گیری می شود.
Secondary outcomes
#1
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The duration of the second stage of labor
The duration of the second stage of labor
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طول مدت مرحله دوم زایمان
طول مدت مرحله دوم زایمان
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From the completion of cervical dilatation until the complete expulsion of the fetus
From the completion of cervical dilatation until the complete expulsion of the fetus
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از هنگام کامل شدن دیلاتاسیون سرویکس تا خروج کامل جنین
از هنگام کامل شدن دیلاتاسیون سرویکس تا خروج کامل جنین
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Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#2
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The duration of the third stage of labor
The duration of the third stage of labor
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طول مدت مرحله سوم زایمان
طول مدت مرحله سوم زایمان
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From the exit of the fetus to the complete exit of the placenta and membranes
From the exit of the fetus to the complete exit of the placenta and membranes
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از خروج جنین تا خروج کامل جفت و پرده ها
از خروج جنین تا خروج کامل جفت و پرده ها
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Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#3
empty
Need to resuscitate the baby
Need to resuscitate the baby
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نیاز به احیا نوزاد
نیاز به احیا نوزاد
empty
Postpartum
Postpartum
empty
پس از زایمان
پس از زایمان
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#4
empty
Apgar score of the baby
Apgar score of the baby
empty
امتیاز آپگار نوزاد
امتیاز آپگار نوزاد
empty
Postpartum
Postpartum
empty
پس از زایمان
پس از زایمان
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#5
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Bishop's score
Bishop's score
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نمره بیشاپ
نمره بیشاپ
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
In cervical dilatations of 4-5, 6-7 and 8-10 cm
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در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
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Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#6
empty
Frequency of uterine contractions
Frequency of uterine contractions
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فراوانی انقباضات رحمی
فراوانی انقباضات رحمی
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
In cervical dilatations of 4-5, 6-7 and 8-10 cm
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در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#7
empty
Intensity of uterine contractions
Intensity of uterine contractions
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شدت انقباضات رحمی
شدت انقباضات رحمی
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In cervical dilatations of 4-5, 6-7 and 8-10 cm
In cervical dilatations of 4-5, 6-7 and 8-10 cm
empty
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#8
empty
Duration of uterine contractions
Duration of uterine contractions
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طول مدت انقباضات رحمی
طول مدت انقباضات رحمی
empty
In cervical dilatations of 4-5, 6-7 and 8-10 cm
In cervical dilatations of 4-5, 6-7 and 8-10 cm
empty
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
در دیلاتاسیون های سرویکس 4-5 و 6-7 و 8-10 سانتی متر
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#9
empty
Need oxytocin
Need oxytocin
empty
نیاز به اکسی توسین
نیاز به اکسی توسین
empty
Postpartum
Postpartum
empty
پس از زایمان
پس از زایمان
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#10
empty
The need for pharmaceutical pain relief methods
The need for pharmaceutical pain relief methods
empty
نیاز به روش های دارویی تسکین درد
نیاز به روش های دارویی تسکین درد
empty
Postpartum
Postpartum
empty
پس از زایمان
پس از زایمان
empty
Observation and examination checklist
Observation and examination checklist
empty
چک لیست مشاهده و معاینه
چک لیست مشاهده و معاینه
#11
empty
Mother's satisfaction with pain relief
Mother's satisfaction with pain relief
empty
رضایت مادر از روش تسکین درد
رضایت مادر از روش تسکین درد
empty
Postpartum
Postpartum
empty
پس از زایمان
پس از زایمان
empty
Likert's questionnaire
Likert's questionnaire
empty
پرسشنامه لیکرت
پرسشنامه لیکرت
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: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول 1
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 911 416 3022
Fax:
Email: mahdiehaly@sbmu.ac.ir
Web page address:
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 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: Floor OneImam Khomeini Hospital, Number One, DeadThe end One,of Shahid Heidary Alley, Azadi AvenueArkhi Blvd Street address - Persian: خیابان آزادیانتهای بلوار شهید آرخی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول 1بیمارستان امام خمینی City - English: ZirabBandare- Torkman City - Persian: زیراببندرترکمن Province: MazandaranGolestan Country: Iran (Islamic Republic of) Postal code: 47818494934891674811 Phone: +98 911 416 302217 3442 4091 Fax: Email: mahdiehalymahdieh-aly@sbmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdiehaly
Full name of responsible person - Persian: مهدیه عالی
Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Fax:
Email: mahdiehaly@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Afshin Zarghi
Full name of responsible person - Persian: افشین زرقی
Street address - English: 5th floor, Building No. 2, Shahid Arabi St, Yemen St, Shahid Chamran Highway
Street address - Persian: بزرگراه شهید چمران، خیابان یمن، خیابان شهید اعرابی، ساختمان شماره 2، طبقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1373916632
Phone: +98 21 23871
Fax:
Email: info@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: MahdiehalyAfshin Zarghi Full name of responsible person - Persian: مهدیه عالیافشین زرقی Street address - English: Floor One5th floor, Number One, Dead end OneBuilding No. 2, Shahid Heidary AlleyArabi St, Azadi AvenueYemen St, Shahid Chamran Highway Street address - Persian: بزرگراه شهید چمران، خیابان آزادییمن، کوچه شهیدری حیدریخیابان شهید اعرابی، بن بست اول، پلاک یکساختمان شماره 2، طبقه اول5 City - English: ZirabTehran City - Persian: زیرابتهران Province: MazandaranTehran Country: Iran (Islamic Republic of) Postal code: 47818494931373916632 Phone: +98 11 4245 027421 23871 Fax: Email: mahdiehalyinfo@sbmu.ac.ir Web page address:
Private
Public
privatepublic
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Mobile: +98 911 416 3022
Fax:
Email: mahdiehaly@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Mobile: +98 911 416 3022
Fax:
Email: mahdieh-aly@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahdieh Aly Full name of responsible person - Persian: مهدیه عالی Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول City - English: Zirab City - Persian: زیراب Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4781849493 Phone: +98 11 4245 0274 Mobile: +98 911 416 3022 Fax: Email: mahdiehalymahdieh-aly@sbmu.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Mobile: +98 911 416 3022
Fax:
Email: mahdiehaly@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sedighe Sedigh Mobarak Abadi
Full name of responsible person - Persian: صدیقه صدیق مبارک آبادی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital, intersection of Ayat A... Hashemi Rafsanjani Highway, ali Asr St.
Street address - Persian: خیابان ولی عصر، تقاطع بزرگراه آیت ا... هاشمی رفسنجانی، مقابل بیمارستان قلب شهیدرجایی، دانشکده 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: 1996835119
Phone: +98 21 8865 5366
Mobile: +98 911 148 3013
Fax:
Email: sedighesedigh@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahdieh AlySedighe Sedigh Mobarak Abadi Full name of responsible person - Persian: مهدیه عالیصدیقه صدیق مبارک آبادی Position - English: StudentAssociate professor Position - Persian: دانشجواستادیار Latest degree: bachelorphd Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Floor OneFaculty of Nursing and Midwifery, Number One, Dead end One,in front of Shahid Heidary AlleyRajaee Heart Hospital, Azadi Avenueintersection of Ayat A... Hashemi Rafsanjani Highway, ali Asr St. Street address - Persian: خیابان آزادیولی عصر، کوچه شهیدری حیدریتقاطع بزرگراه آیت ا... هاشمی رفسنجانی، بن بست اولمقابل بیمارستان قلب شهیدرجایی، پلاک یک، طبقه اولدانشکده پرستاری و مامایی City - English: ZirabTehran City - Persian: زیرابتهران Province: MazandaranTehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 47818494931996835119 Phone: +98 11 4245 027421 8865 5366 Mobile: +98 911 416 3022148 3013 Fax: Email: mahdiehalysedighesedigh@sbmu.ac.irgmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi Avenue
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Mobile: +98 911 416 3022
Fax:
Email: mahdiealy@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdieh Aly
Full name of responsible person - Persian: مهدیه عالی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Heidary Alley, Azadi St
Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری
City - English: Zirab
City - Persian: زیراب
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4781849493
Phone: +98 11 4245 0274
Mobile: +98 911 416 3022
Fax:
Email: mahdie-aly@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahdieh Aly Full name of responsible person - Persian: مهدیه عالی Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Floor One, Number One, Dead end One, Shahid Heidary Alley, Azadi AvenueSt Street address - Persian: خیابان آزادی، کوچه شهیدری حیدری، بن بست اول، پلاک یک، طبقه اول City - English: Zirab City - Persian: زیراب Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4781849493 Phone: +98 11 4245 0274 Mobile: +98 911 416 3022 Fax: Email: mahdiealymahdie-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 primiparous women referred to Imam Khomeini Hospital in Bandar-e Torkman 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 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.
Participants/Inclusion and exclusion criteria
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
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 primiparous 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
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060761N1
Registration date:2024-02-07, 1402/11/18
Registration timing:prospective
Last update:2024-03-08, 1402/12/18
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
2024-04-12, 1403/01/24
Expected recruitment end date
2024-09-20, 1403/06/30
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 Primiparous Women
Public title
The Effect of Acupressure on Pain Intensity in the First Stage of Labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
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 primiparous women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mahdieh Aly
Street address
Imam Khomeini Hospital, The end of Shahid Arkhi Blvd