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Evaluation of accupuncture effectiveness in comparison with petidin on labour pain and delivery length

Protocol summary

Summary
The aim of this study is evaluation of acupuncture effectiveness on labor pain. Inclusion criteria:18-35 age, first or second term pregnancy(37-42 weeks),active phase of labor (4-5 cm dilatation), no history of abortion, EP,Mole, chronic or acute illness, infertility, no CPD, have not received any painkiller until four hours before intervention . Exclusion criteria: fetal distress, severe maternal hemorrhage and thick meconium pregnant women in control group underwent the hospital's routine cares.The Pethidine group, after entering into the active phase of labor, received 50 mg intramuscular Pethidine but the injection was no longer repeated.In acupuncture group when entering into the active phase of labor was proved two needles were inserted in LI 4 point (Hegu point) in two hands and in ST-36 point (Zu san li point) in two legs that were disinfected by alcohol.The needles are left in the points for 20 to 30 minutes. Before intervention, using VAS pain ruler, pain severity was measured in three groups and between the contractions. Then thirty minutes after intervention, pain severity was again assessed, and once more it was measured at the end of the first phase at full dilatation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201311157513N9
Registration date: 2013-12-22, 1392/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-22, 1392/10/01
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2009-09-10, 1388/06/19
Expected recruitment end date
2010-09-13, 1389/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of accupuncture effectiveness in comparison with petidin on labour pain and delivery length
Public title
Effectiveness of accupuncture on labour pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:18-35 age:first or second term pregnancy(37-42 weeks):active phase of labor (4-5 cm dilatation):no history of abortion, Ep:Mole:chronic or acute illness:infertility: no CPD:have not received any painkiller until four hours before intervention . Exclusion criteria: fetal distress:severe maternal hemorrhage :thick meconium
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Isfahan University of Medical Sciences. Etical commitee
Street address
Isfahan medical school-Hezar Jerib St-Azadi Square
City
Isfahan
Postal code
8184851153
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
81206

Health conditions studied

1

Description of health condition studied
Labor pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

Primary outcomes

1

Description
ِDecrease labour pain
Timepoint
Befor and after intervetion and at the end of active phase
Method of measurement
Macgil visual scale

Secondary outcomes

1

Description
Newborn side effects
Timepoint
At birth time
Method of measurement
APGAR score

Intervention groups

1

Description
control group- no intervention
Category
N/A

2

Description
Acupunture group In this group accupanuctur was done at active phase of labour for reduce severity of pain
Category
Prevention

3

Description
petidin group inthis group 50 mg petedin was injected at active phase of labour for reduce labour pain
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Alzahra Hospital
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Alzahra Hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
Shahid Beheshti Hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
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
Isfahan University of Medical Science
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associating professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
8184851153
Phone
+98 31 1630 3620
Fax
+98 31 1639 6321
Email
tehrani@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Assosiation professor
Other areas of specialty/work
Street address
Alzahra hospital
City
Isfahan
Postal code
8184851153
Phone
+98 31 1630 3620
Fax
+98 31 1630 6321
Email
tehrani @med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associating professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
8184851153
Phone
+98 31 1630 3620
Fax
+98 31 1630 6321
Email
tehrani@med.mui.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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