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Comparison of Effect Acupressure Yongquan point(KI-1) with Hugo point(LI-4) on Severity of Labor pain and outcome of Delivery in Primiparous women

Protocol summary

Summary
The purpose of study and studt design:: Comparison of Effect Acupressure Yongquan point(KI-1) with Hugo point(LI-4)on Severity of Labor pain and outcome of Delivery in Primiparous women -random-not blinded-placebo not used.The study of population:primiparous women with single fetus,gestatioanal age between 37-40weeks,cephallic presentation.2.active phase(3-4)cm3.no high risk pregnancy(preeclampsia,deceleration fetus activity.dead fetus,polyhydraminious.oligohydraminious,rubture of membarne over than 12 hours,infertility history).5.no skin disses(exema).6.no use of anestesia.exclusion criteria:1.oxytocin induction.2.no normal heart rate that need to cesarean cection.3.problem in labor(cord prolapse...4.lack of willingness to continue in every phase.5.areest need to cesarean cection.sample:58 eligible participants waz selected from the population and randomly divided into3 equal groups of26(yongquan acupressue,hugo acupressure and control group).intervention:using acupressure simulataneously at the begining of the dilations of the uterus contraction-control group(not intervention)-completion of the questionnaires:before of the intervention,immedietly,30minute afte,60minute after interventionin in both group.study outcome:The Effect Acupressure (Yongquan point(KI-1) with Hugo point(LI-4)) on Severity of Laborpain and outcome of Delivery(duration of labor,perineum laceration,episiatomy and neonate apgar) in Primiparous women.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120315643N1
Registration date: 2014-01-07, 1392/10/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-07, 1392/10/17
Registrant information
Name
Nasim Partash
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7282
Email address
partash@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2013-07-21, 1392/04/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect Acupressure Yongquan point(KI-1) with Hugo point(LI-4) on Severity of Labor pain and outcome of Delivery in Primiparous women
Public title
Effect Of Acupressure On Delivery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:primiparous women with single fetus,gestatioanal age between 37-40weeks,cephallic presentation؛active phase(3-4)cm؛no chronic illness(heart disses,blood pressure and diabetes)؛no high risk pregnancy(preeclampsia,deceleration fetus activity.dead fetus,polyhydraminious.oligohydraminious,rubture of membarne over than 12 hours,infertility history)؛no skin disses(exema)؛no use of anesthesia.exclusion criteria:oxytocin induction؛no normal heart rate that need to cesarean cection؛problem in labor(cord prolapse...؛lack of willingness to continue in every phase؛areest need to cesarean cection.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shiraz university of medical sciences
Street address
7th flat,central department of shiraz oaf medical science,zand steet, shiraz.
City
shiraz
Postal code
7193613119
Approval date
2013-07-16, 1392/04/25
Ethics committee reference number
ct-92-6612

Health conditions studied

1

Description of health condition studied
Severity of labor pain and Outcome of Delivery
ICD-10 code
O80-O84
ICD-10 code description
Delivery

Primary outcomes

1

Description
severity of labor pain
Timepoint
prior,immedietly,30minutes and 60minutes after intervention
Method of measurement
Visual Anlog Sccale

Secondary outcomes

1

Description
duration of first and second stage of labor,episiatomy,perineum lacerationand neonate apgar
Timepoint
after the intervention
Method of measurement
quastionrie

Intervention groups

1

Description
intervention group Hogo:using acupressure simultaneouslyin 4-3,8-7and second stage of labor at the begining of the dilation of the uterin contraction for 10 minutes
Category
Prevention

2

Description
intervention group Yongquan:using acupressure simultaneously in 4-3,8-7 cm and second stage of labor at the begining of the dilation of the uterin contraction for 10 minutes
Category
Prevention

3

Description
without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Nasim Partash
Street address
Abiverdi street,Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Shiraz University Of Medical Science
Full name of responsible person
Dr.Gholam Reza Hatam
Street address
7th Flat، Central department of Shiraz University Of Medical Science,Zand Street,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
ct-92-6612
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Shiraz University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Fatemeh Ciege of Nursing And Midwifery
Full name of responsible person
Maasumeh Kaviani
Position
Faculty Member,MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square، Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
kavianimaasumeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Maasumeh Kaviani
Position
Faculty Member,MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square، Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 1647 4258
Fax
+98 71 1647 4254
Email
kavianimaasumeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh Cllege of Nursing And Midwifery
Full name of responsible person
Nasim Partash
Position
Student,MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square، Shiraz
City
Shiraz
Postal code
7188978185
Phone
+98 71 1647 4258
Fax
Email
npartash@yahoo.comn.partash@gmail.compartash@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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