History
# Registration date Revision Id
2 2019-07-29, 1398/05/07 112745
1 2018-04-17, 1397/01/28 42609
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  • Protocol summary

    Investigating the effect of pressure on GB21 on labor pain
    Investigating the effect of pressure on GB21 on labor pain severity and length of delivery
    بررسی تاثیر فشار در نقطه GB21 بر درد زایمان
    بررسی تاثیر فشار در نقطه GB21 بر شدت درد و طول مدت زایمان
    Mothers who are admitted to the active phase of labor, selected according to inclosion criteria. After giving explanations to individuals, they are randomly divided into separate rooms. Intervention teams are unaware of how to intervene. How to handle the pain assessment The pain intensity before the intervention, immediately after the intervention, is 30 minutes and 60 minutes after the intervention using a pain reliever. The results are recorded in the checklist and the examination is recorded.
    Mothers who are admitted to the active phase of labor, selected according to inclosion criteria. After giving explanations to individuals, they are randomly divided into separate rooms. Intervention teams are unaware of how to intervene. How to handle the pain assessment The pain intensity before the intervention, immediately after the intervention, is 30 minutes and 60 minutes after the intervention using a pain reliever. The results are recorded in the checklist and the examination is recorded. although during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages will measured
    افراد مورد پژوهش مادران بستری شده در فاز فعال زایمانی ، که با رعایت معیار های ورود انتخاب شده اند ، می باشند. بعد از ارائه توضیحات به افراد، انها به صورت تصادفی تقسیم و در اتاق های جداگانه قرار داده می شوند.گروه های مداخله ای از نحوه مداخله آگاهی ندارند. نحوه انجام مداحله ارزیابی شدت درد قبل از مداخله، بلافاصله بعد از مداخله، 30 دقیقه و 60 دقیقه بعد از مداخله با استفاده از خط کش درد می باشد. نتایج در چک لیست مشاهده و معاینه ثبت میگردد.
    افراد مورد پژوهش مادران بستری شده در فاز فعال زایمانی ، که با رعایت معیار های ورود انتخاب شده اند ، می باشند. بعد از ارائه توضیحات به افراد، انها به صورت تصادفی تقسیم و در اتاق های جداگانه قرار داده می شوند.گروه های مداخله ای از نحوه مداخله آگاهی ندارند. نحوه انجام مداحله ارزیابی شدت درد قبل از مداخله، بلافاصله بعد از مداخله، 30 دقیقه و 60 دقیقه بعد از مداخله با استفاده از خط کش درد می باشد. نتایج در چک لیست مشاهده و معاینه ثبت میگردد. همچنین درطی 3دوره مختلف درمرحله اول زایمان دیلاتاسیونهای 3-5سانت، 6-7سانت و 8-10سانت مداخله اعمال و طول مدت مراحل زایمانی اندازه گیری میشود
    Severity of labor pain؛ Satisfaction of the treatment course
    Severity of labor pain؛ Satisfaction of the treatment course, length of delivery
    شدت درد زایمان؛ رضایت از دوره درمان
    شدت درد زایمان؛ رضایت از دوره درمان، طول مدت زایمان
  • General information

    0
    empty
    2018-01-21, 1396/11/01
    2018-02-20, 1396/12/01
    2018-05-20, 1397/02/30
    2018-09-21, 1397/06/30
    The effect of pressure on bile duct 21 on labor pain in primiparous women
    The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
    تاثیر فشار بر نقطه کیسه صفراوی 21 بر درد زایمان در زنان نخست زا
    تاثیر فشار بر نقطه کیسه صفراوی 21 بر شدت درد و طول مدت زایمان در زنان نخست زا
    The effect of pressure on bile duct 21 on labor pain in primiparous women
    The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
    بررسی تاثیر فشار بر نقطه کیسه صفراوی 21 بر درد زایمان در زنان نخست زا
    بررسی تاثیر فشار بر نقطه کیسه صفراوی 21 بر شدت درد و طول مدت زایمان در زنان نخست زا
    empty
    empty
  • Primary outcomes

    #1
    empty
    Length of Delivery
    empty
    طول مدت زایمان
    empty
    during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage
    empty
    درمرحله اول زایمان دیلاتاسیونهای 3-5سانت، 6-7سانت و 8-10سانت
    empty
    minutes
    empty
    دقیقه
  • Intervention groups

    #1
    first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.
    first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured.
    گروه اول مداخله: در گروه مداخله با طب فشاری برنقطه کیسه صفراوی 21 ، فشار به مدت یک دقیقه بر نقطه مورد نظر در طی درد های رحمی اعمال شده، 30 ثانیه استراحت و مجدد به مدت 30 دقیقه فشار روی نقطه اعمال می گردد. شدت درد قبل از مداخله،بلافاصله بعد از مداخله ،30 دقیقه و 60 دقیقه بعد سنجیده می شود.
    گروه اول مداخله: در گروه مداخله با طب فشاری برنقطه کیسه صفراوی 21 ، فشار به مدت یک دقیقه بر نقطه مورد نظر در طی درد های رحمی اعمال شده، 30 ثانیه استراحت و مجدد به مدت 30 دقیقه فشار روی نقطه اعمال می گردد. شدت درد قبل از مداخله،بلافاصله بعد از مداخله ،30 دقیقه و 60 دقیقه بعد سنجیده می شود. همچنین طول مدت فاز های زایمان در دیلاتاسیون های 3-5سانت، 6-7سانت و 8-10سانت بر حسب دقیقه اندازه گیری شد.
    #2
    Intervention group 2: The second group is pressure on shame point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.
    Intervention group 2: The second group is pressure on shame point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured
    گروه مداخله 2: گروه دوم فشار بر نقطه نا به جا می باشد.این نقطه در فاصله یک تا دو انگشت شست از نقطه کیسه صفراوی 21 به سمت خارج بدن قرار دارد. فشار به مدت یک دقیقه بر نقطه مورد نظر در طی درد های رحمی اعمال شده، 30 ثانیه استراحت و مجدد به مدت 30 دقیقه فشار روی نقطه اعمال می گردد. شدت درد قبل از مداخله،بلافاصله بعد از مداخله ،30 دقیقه و 60 دقیقه بعد سنجیده می شود.
    گروه مداخله 2: گروه دوم فشار بر نقطه نا به جا می باشد.این نقطه در فاصله یک تا دو انگشت شست از نقطه کیسه صفراوی 21 به سمت خارج بدن قرار دارد. فشار به مدت یک دقیقه بر نقطه مورد نظر در طی درد های رحمی اعمال شده، 30 ثانیه استراحت و مجدد به مدت 30 دقیقه فشار روی نقطه اعمال می گردد. شدت درد قبل از مداخله،بلافاصله بعد از مداخله ،30 دقیقه و 60 دقیقه بعد سنجیده می شود. طول مدت زایمان در دیلاتاسیون های 5-3و6-7و8-10 سانتی متر سنجیده شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Mofatheh Hospital in Varamin, affiliated to Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: بیمارستان مفتح ورامین وابسته به انشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: hamideh torkiyan
    Full name of responsible person - Persian: حمیده ترکیان
    Street address - English: Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
    Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، روبه روی بیمارستان قلب شهیدرجایی، مجتمع آموزشی وپژوهشی نیایش، دانشکده پرستاری ومامایی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 8865 5366
    Fax:
    Email: iranifarvahar@gmail.com
    Web page address: http://nm.sbmu.ac.ir/?siteid=244
    Name of recruitment center - English: Mofatheh Hospital in Varamin, affiliated to Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: بیمارستان مفتح ورامین وابسته به انشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Hamideh Torkiyan
    Full name of responsible person - Persian: حمیده ترکیان
    Street address - English: Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
    Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، روبه روی بیمارستان قلب شهیدرجایی، مجتمع آموزشی وپژوهشی نیایش، دانشکده پرستاری ومامایی دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 8865 5366
    Fax:
    Email: iranifarvahar@gmail.com
    Web page address: http://nm.sbmu.ac.ir/?siteid=244
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: DR ABBAS RAHIMI
    Full name of responsible person - Persian: دکتر عباس رحیمی
    Street address - English: Vice Chancellor for research of Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
    Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، روبه روی بیمارستان قلب شهیدرجایی، مجتمع آموزشی وپژوهشی نیایش، دانشکده پرستاری ومامایی دانشگاه علوم پزشکی شهید بهشتی، معاونت پژوهشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 7756 1721
    Fax:
    Email: arahimiuk@yahoo.com
    Web page address: http://nm.sbmu.ac.ir/?siteid=244&pageid=11383
    contact.organization_id:
    Name of organization / entity - English: Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشكده پرستاري مامايي دانشگاه علوم پزشكي شهید بهشتی
    Full name of responsible person - English: Dolatian Mahrokh
    Full name of responsible person - Persian: دکتر ماهرخ دولتیان
    Street address - English: Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
    Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، روبه روی بیمارستان قلب شهیدرجایی، مجتمع آموزشی وپژوهشی نیایش، دانشکده پرستاری ومامایی دانشگاه علوم پزشکی شهید بهشتی، معاونت پژوهشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 8820 2518
    Fax:
    Email: mhdolatian@gmail.com
    Web page address:
  • Sharing plan

    undecided
    yes
    empty
    The results of the study will be divided into two parts: the length of delivery and the severity of pain
    empty
    نتایج مطالعه در دو قسمت طول مدت زایمان و شدت درد منتشر خواهند شد
    empty
    After publishing the results as an article
    empty
    پس از انتشار نتایج به صورت مقاله
    empty
    Researchers working in academic places
    empty
    محققین شاغل در موسسات دانشگاهی و علمی
    empty
    Respecting copyright and solely in order to help the researcher to conduct his more accurate study
    empty
    با رعایت حق کپی رایت و تنها در جهت کمک به محقق برای انجام مطالعه دقیق تر خود
    empty
    correspond email
    empty
    ایمیل فرد مسوول
    empty
    By sending an email and after reviewing the request, it will be answered in case of discretion
    empty
    با ارسال ایمیل و پس از بررسی درخواست در صورت صلاحدید پاسخ داده می شود

Protocol summary

Study aim
Investigating the effect of pressure on GB21 on labor pain severity and length of delivery
Design
Clinical trial, community-based, and pragmatic control group, with parallel groups, blind, randomized,
Settings and conduct
Mothers who are admitted to the active phase of labor, selected according to inclosion criteria. After giving explanations to individuals, they are randomly divided into separate rooms. Intervention teams are unaware of how to intervene. How to handle the pain assessment The pain intensity before the intervention, immediately after the intervention, is 30 minutes and 60 minutes after the intervention using a pain reliever. The results are recorded in the checklist and the examination is recorded. although during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages will measured
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous; age18-35 years; cephalic presentation; Gestational age 37-41 weeks; Singleton; ability to read and write; tendency to use analgesia; be in active phase; Exclusion criteria: not having willingness to work with researcher; Conditions lead to cesarean section
Intervention groups
Pressure group on GB 21; Pressure group on shame point; Control group In the pressure group on GB 21, the researcher pushes his right hand over the point. Using pressure during uterine contractions. In the pressure group on the shame point with the conditions, the pressure is applied to theshame point. In the control group, the researcher only performs the necessary measures in labor.
Main outcome variables
Severity of labor pain؛ Satisfaction of the treatment course, length of delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100503003860N34
Registration date: 2018-04-17, 1397/01/28
Registration timing: registered_while_recruiting

Last update: 2019-12-04, 1398/09/13
Update count: 1
Registration date
2018-04-17, 1397/01/28
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
Public title
The effect of pressure on bile duct 21 on labor pain severity and length of delivery in primiparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be primiparous cephalic presentation ability to read and write 18-35years Gestational age 37-41 weeks and Singletonage tendency to use analgesia be in active phase
Exclusion criteria:
Do not have to work with a researcher Conditions lead to cesarean section high risk pregnancies skin disorders chronic diseases mental and anatomical disorders
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: 174
Randomization (investigator's opinion)
Randomized
Randomization description
The appointment of individuals in groups was randomized using the RANDOM ALLOCATION SOFTWARE FOR CLINICAL TRIAL software. Using this software, information about the sample number, the number of groups, the groups names will be taken into the data and output software, which includes the list of random groups of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a full description of the research is given to the research units at first, and the patient is given written consent for participation in the study. Then Pregnant mothers are placed in separate rooms to avoid being aware of the intervention. In the control group only routine care is applied
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SBMU.PHNM.1395.705

Health conditions studied

1

Description of health condition studied
labor pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Severity of labor pain
Timepoint
Before the intervention,Immediately after intervention, 30 minutes and 60 minutes after intervention
Method of measurement
Numerical rating scale

2

Description
Length of Delivery
Timepoint
during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage
Method of measurement
minutes

Secondary outcomes

1

Description
Mode of delivery
Timepoint
once-after delivery
Method of measurement
Questioner

2

Description
Neonatal Apgar Score
Timepoint
1 and 5 minute after birth
Method of measurement
check list

Intervention groups

1

Description
first Intervention group: In the intervention group with acupressure on the bile duct 21, the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured.
Category
Other

2

Description
Intervention group 2: The second group is pressure on shame point. This point is located between 1 and 2 thumbs from the point of the Gallbladder21 at the outside of the body.the pressure was applied for one minute to the desired point during uterine pain and applied for 30 minutes. The severity of pain is measured immediately before intervention, immediately after intervention, 30 minutes and 60 minutes later.Intervention was applied during 3courses in 3-5cm, 6-7cm, and 8-10cm dilatations in first stage of childbirth and duration of delivery stages was measured
Category
Other

3

Description
Control group: The third group is the control group. This group receives all routine care except for intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofatheh Hospital in Varamin, affiliated to Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Torkiyan
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
iranifarvahar@gmail.com
Web page address
http://nm.sbmu.ac.ir/?siteid=244

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dolatian Mahrokh
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
mhdolatian@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dept. of Research, School of Nursing and Midwifery, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Torkiyan
Position
Graduate Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
iranifarvahar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
Assistant professor, PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Email
g.ozgoli@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamideh Torkiyan
Position
Midwifery Masters Degree
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Behehshti University of Medical Sciences, Faculty of Nursing and Midwifery, in frint of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr St. Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Email
iranifarvahar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the study will be divided into two parts: the length of delivery and the severity of pain
When the data will become available and for how long
After publishing the results as an article
To whom data/document is available
Researchers working in academic places
Under which criteria data/document could be used
Respecting copyright and solely in order to help the researcher to conduct his more accurate study
From where data/document is obtainable
correspond email
What processes are involved for a request to access data/document
By sending an email and after reviewing the request, it will be answered in case of discretion
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