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Effect of sanyinjiao (SP6) - hegu (LI4) points pressure on labor pain and delivery length in nulliparous women: A randomized controlled trial

Protocol summary

Summary
The aim of this randomized controlled trial is to determine the effect of acupressure at the sanyinjiao (SP6)- hegu (LI4) points on labor pain and delivery length. It will be conducted on 84 nulliparous women and eligibility criteria (begin of active phase of labor, gestational age 37-42 weeks, single pregnancy, cephalic presentation) at sabalan and alavi hospitals in ardabil. After getting written informed consent, we will randomly allocate participants into intervention group (press of SP6- LI4 points) and control group (press of ineffective points on leg and hand) using permuted block randomization with block sizes of four and six. In intervention group, SP6 and LI4 points (on the both organs) in 4, 6, 8, 10 cm dilatation for 20 minute, alternatively each one for 5 minute during the contraction will be pressed by the research assistant . In control group, ineffective points on legs and hands in the same manner will be pressed by the research assistant. Before and after intervention, pain severity will be assessed by the investigator using 10 cm visual scale. Length of delivery time will be calculated in two stages, from 4 cm cervical dilatation to full cervical dilatation and full cervical dilatation to the delivery and will be recorded in the questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106143027N5
Registration date: 2012-01-21, 1390/11/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-21, 1390/11/01
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-30, 1390/11/10
Expected recruitment end date
2012-05-30, 1391/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sanyinjiao (SP6) - hegu (LI4) points pressure on labor pain and delivery length in nulliparous women: A randomized controlled trial
Public title
Effect of sanyinjiao- hegu points pressure on labor pain and delivery length in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous women, age 18-35 years, gestational age 37-42 weeks, single pregnancy, four cm dilatation or before, cephalic presentation, membranes intact at the initial examination or rupture of membranes less than 6 hours, spontaneous onset of uterine contractions, lack of high-risk pregnancy, fetus weight less than 4000 gram and lack of lesion in sanyinjiao- hego points. Exclusion criteria: any need to emergency intervention in mother and fetus and cancel to continue working.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht Street
City
Tabriz
Postal code
Approval date
2012-01-16, 1390/10/26
Ethics committee reference number
9076

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
Labor pain
Timepoint
Before and after intervention in 4, 6, 8 and 10 cm dilatations
Method of measurement
10 cm visual analogue scale

Secondary outcomes

1

Description
Duration of the active phase of labor
Timepoint
From 4 cm cervical dilatation to full dilatation
Method of measurement
Vaginal examination

2

Description
Duration of second stage of labor
Timepoint
From full cervical dilatation to expulsion
Method of measurement
Vaginal examination

Intervention groups

1

Description
In intervention group: The research assistant will press SP6 and LI4 points (on the both organs) in 4, 6, 8, 10 cm dilatation for 20 minute, alternatively each one for 5 minute, during the contraction
Category
Other

2

Description
In control group: The research assistant will press ineffective points on legs and hands for 20 minute during the contraction (alternatively each one for 5 minute) in 4, 6, 8 and 10 cm dilatation
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sabalan Hospital
Full name of responsible person
Rafat Kazemzadeh
Street address
Vahdat Square
City
Ardabil

2

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Rafat Kazemzadeh
Street address
Saheli Street
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz University of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
Master of Sciences in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
sehhatief@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Rafat Kazemzadeh
Position
Master of Sciences Student in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
r.kazemzadeh@arums.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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