Protocol summary

Summary
Labor pain is often severe. Unrelieved labor pain can have an adverse effect on both the mother and the infant. The aim of this study was to compare Hoku point (LI4) acupressure and San-Yin-Jiao (SP6) acupressure in labor pain and length of delivery time in nulliparous women in Iran hospital. A randomized clinical trial was performed on 60 nulliparas women who were at the beginning of active phase of labor (4 cm dilatation of cervix). The women were randomly assigned to one of the two groups. The Sanyinjiao group received acupressure at Sanyinjiao points for 20 minute during contractions on two feet. In the Hoku group, acupressure served in the same manner at Hoku points on two hands. Data were collected by means of questionnaires. Labor pain was measured with visual-analogue scale: before the intervention and after the intervention in 4, 6, 8 and 10 cm cervical dilation. Length of delivery time was calculated in two stages: from 4 cm cervical dilation to full cervical dilatation and full cervical dilatation to the delivery. Inclusion criteria being at the beginning of active phase of labor, gestational age between 38-42 weeks, single fetus, cephalic presentation and primiparous women. Exclusion criteria: any psychotic and diagnosed anatomic disorder, chronic diseases, any inflammation in the acupressure region, polyhydraminus and oligohydramimus ,fetal movement reduction, intrauterine growth retardation, fetal death, CPD, history of infertility, abnormal pattern of fetal heart rate , and participants who were taking psychotherapeutic drugs were excluded. Primary outcome is labor pain and Secondary outcome is duration of the active phase of labor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804232170N1
Registration date: 2008-01-20, 1386/10/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2008-01-20, 1386/10/30
Registrant information
Name
Tahmineh Salehian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 7223 3735
Email address
salehian@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2008-01-20, 1386/10/30
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Hoku point (LI4) acupressure and San-Yin-Jiao(SP6) acupressure on labor pain and length of delivery time in nulliparous women in Iran hospital in 2008-2009 .
Public title
Comparing Hoku point (LI4) acupressure and San-Yin-Jiao(SP6) acupressure on labor pain and length of delivery time in nulliparous women in Iran hospital in 2008-2009 .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being at the beginning of active phase of labor, gestational age between 38-42 weeks, single pregnancy, cephalic presentation of the fetus, and primiparous women, good health, not diagnosed with any specific diseases, and planned have a vaginal delivery of a single fetus. Exclusion criteria: Any psychotic and diagnosed anatomic disorder, chronic diseases such as cardiopulmonary disease, diabetes mellitus, skin disease, any damage, inflammation and eczema in the acupressure region, women with gestational hypertension, polyhydraminus and oligohydramimus known with sonography, women with fetal movement reduction, intrauterine growth retardation, fetal death, history of chronic pelvic pain, CPD, women with a history of infertility, abnormal pattern of fetal heart rate, and participants who were taking psychotherapeutic drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan university of Medical sciences
Street address
Zahedan university of Medical sciences
City
Zahedan
Postal code
Approval date
2008-01-20, 1386/10/30
Ethics committee reference number
606

Health conditions studied

1

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

Primary outcomes

1

Description
labor pain
Timepoint
Labor pain was measured four times using a structured questionnaire, a subjective labor pain scale (visual-analogue scale [VAS]): before and 20 minute after the intervention in 4, 6, 8 and 10 cm cervical dilation
Method of measurement
visual-analogue scale

Secondary outcomes

1

Description
duration of the active phase of labor
Timepoint
from 4 cm cervical dilation to full cervical dilatation
Method of measurement
timer

Intervention groups

1

Description
In the Hoku group acupressure served in the same manner as in the other group at Hoku points on two hands. This was carried out in Hoku point throughout contractions
Category
Other

2

Description
The Sanyinjiao group received acupressure at Sanyinjiao points for 20 minute during contractions on two feet
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran hospital of Iranshahr
Full name of responsible person
Street address
City
Iranshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan university of Medical sciences
Full name of responsible person
Dr.Abaslat Borgi
Street address
Zahedan university of Medical sciences
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan university of Medical sciences-
Full name of responsible person
Mrs Neda Mohamadinia
Position
Academic Member Dept of Nursing & Midwifery, University of Medical Sciences , Zahedan
Other areas of specialty/work
Street address
Midwifery Dep.Iranshahr Faculty of Medical sciences
City
Iranshahr
Postal code
Phone
+98 54 7331 0482
Fax
Email
Tahminehsalehian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences , Zahedan
Full name of responsible person
Mrs Tahmineh Salehian
Position
master degree of Midwifery
Other areas of specialty/work
Street address
Academic Member Dept of Nursing & Midwifery, University of Medical Sciences , Zahedan
City
Iranshahr
Postal code
Phone
+98 54 7331 0482
Fax
Email
Tahminehsalehian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mrs Neda Mohamadinia
Position
Other areas of specialty/work
Street address
City
Iranshahr
Postal code
Phone
Fax
Email
Tahminehsalehian@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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