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The effect ofdifferent point of acupressure on labor pain and length of labor

Protocol summary

Summary
After sample selection, they are given neutral information about the study, and written consent will obtained. The subjects will selected through drawing numbers randomly by researcher and assigning each number to a specific group are dividing into 5 groups:2 acupressure groups(L14 acupressure and SP6 acupressure ), 2 touching groups(touching LI4 and SP6 points) and control group( that they are not using any method of pharmacological or non-pharmacological pain relief). In the study methodology the pain intensity in each group will measure with the visual analog scale (VAS) before and after intervention. Then various intervals after the intervention (30 minutes after intervention, 1 h after treatment and every hour until delivery), pain intensity will measure using this tool. In acupressure group the pressure will apply by a trained and registered midwife, who has certification in acupressure method. The pressure will apply bilaterally within each contraction. Prior to the pressure the patient will ask to take a deep breath then applying a rotational and vibration pressure for 60 second then 60 second of rest apply after that, and this cycle to be continue for 30 minutes. Accurate location of the acupoint is confirm if the subjects feel heaviness, pressure, tingling, or numbness in the area or a pleasant feeling and in case of feeling severe pain at the site of pressure, the pressure will interrupt temporarily and will start again after a few minutes. The intensity of the pressure is partially discolored nail bed is painted white. In the touching groups, the same points will touch with the same method.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112415526N1
Registration date: 2013-12-14, 1392/09/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-14, 1392/09/23
Registrant information
Name
Fatemeh Dabiri
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 1666 6367
Email address
fateme.dabiri@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for reproductive health & infertility, Hormozgan university of medical sciences
Expected recruitment start date
2013-11-06, 1392/08/15
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect ofdifferent point of acupressure on labor pain and length of labor
Public title
Effect of acupressuer on labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: pregnant women with gestational age of 37-42 weeks with cephalic presentation and 4-5 cm cervical dilatation in active phase of spontaneous onset of labor; singleton pregnancy, with no history of medical disease, history of infertility, previous pelvic surgery, cesarean section; lack of any problem during present gestation; rupture of membranes over 6 hours; presence of meconium in the amniotic fluid; inappropriate pelvic; taking narcotic within the past 8 hours; over 8 cm cervical dilatation, and any fetal distress. If a subject requires undergoing caesarean section or needing for labor augmentation with oxytocin, or don’t like to continue, will exclude from the study.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Department of resrarch and tecnology,Hormozgan universiry of medical sciences
Street address
Shahid mohamadi hospital
City
Bandar Abbas
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
HEC/90/5/6

Health conditions studied

1

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

Primary outcomes

1

Description
pain relife
Timepoint
Before and after intervention. Then various intervals after the intervention (30 minutes after intervention, 1 h after treatment and every hour until delivery),
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
lenght of labor
Timepoint
first & second stage of labor
Method of measurement
minute

Intervention groups

1

Description
there are 2 intervention groups: one of them is : LI4 acupressure that located between the skin of the thumb and the index finger where the joints located at metacarpal bone of the thumb and index finger the pressure will apply bilaterally within each contraction( in 1st stage of active phase of labor)for 60 . second then 60 second of rest will apply after that, and this cycle will be continue for 30 minutes . Then before intervention various and intervals after the intervention, pain intensity will be measure
Category
Other

2

Description
in SP6 acupressure group that located 4 finger above the inner tibia of leg,pressure will apply bilaterally within each contraction( in 1st stage of active phase of labor)for 60 second then 60 second of rest will apply after that, and this cycle will be continue for 30 minutes . Then before intervention various and intervals after the intervention, pain intensity will be meas
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Shariati hospital
Full name of responsible person
Street address
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Hormozgan university of medical sciences
Full name of responsible person
Research center for reproductive health & infertility,
Street address
Eastern angel of Shahid mohamadi hospital,jomhoori Islami BLV,Bandar abbas
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Hormozgan 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
Name of organization / entity
Homozgan university of medical sciences
Full name of responsible person
Fateme Dabiri
Position
MSc, faculty member
Other areas of specialty/work
Street address
Nursing & midwifery collage
City
Bandar Abbas
Postal code
Phone
+98 76 1666 6367
Fax
Email
fateme.dabiri@hums.ac.ir; fateme.dabiri@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hormozgan university of medical sciences
Full name of responsible person
Fateme Dabiri
Position
MSc
Other areas of specialty/work
Street address
Nursing & Midwifery collage
City
Bandar Abbas
Postal code
Phone
+98 76 1666 6367
Fax
Email
fateme.dabiri@hums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Arefeh shahi
Position
m.s degreee- faculty member
Other areas of specialty/work
Street address
Hormozgan University of Medical Sciences, Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 76133371901
Fax
+98 761337192
Email
a_sh4310@yahoo.com
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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