A randomized clinical trial on comparison of efficacy of LI-4 and SP-6 acupuncture points and Sham acupuncture on intensity and duration of labor pain in pregnant women
In this randomized clinical trial the efficacy of LI-4 and SP-6 acupuncture points and Sham acupuncture was compared on the intensity and duration of labor pain in pregnant women. In this study, 63 pregnant women in active phase of labor were recruited (32 in intervention group and 31 in control group). This study was single-blinded, while the pregnant women were not aware of their groups (intervention group versus control group). Inclusion criteria: 1-Persian speaking women 2-maternal age 20 - 40 years old 3-nulliparity 4-singleton pregnancy 5-being healthy 6-37-42 weeks of gestational age 7-cephalic fetal presentation 8-mothers with normal healthy fetus 9-healthy mothers with no underlying diseases such as overt diabetes, gestational diabetes and preeclampsia
Exclusion criteria: 1-mothers who received analgesics prior to conducting intervention 2-mothers who needs emergency cesarean section. In this study, LI-4 and SP-6 acupuncture points was conducted in intervention group. Also, Sham acupuncture was conducted on the same points in control group. The primary outcomes were considered as comparing the pain score before and after intervention and duration of labor.
General information
Acronym
Preterm delivery
IRCT registration information
IRCT registration number:IRCT2013061310657N2
Registration date:2015-07-26, 1394/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Najmeh Maharlouei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2799
Email address
maharluei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2011-10-01, 1390/07/09
Expected recruitment end date
2012-09-30, 1391/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial on comparison of efficacy of LI-4 and SP-6 acupuncture points and Sham acupuncture on intensity and duration of labor pain in pregnant women
Public title
Efficacy of conducting acupuncture on intensity and duration of labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Persian speaking women 2-maternal age 20 - 40 years old 3-nulliparity 4-singleton pregnancy 5-being healthy 6-37-42 weeks of gestational age 7-cephalic fetal presentation 8-mothers with normal healthy fetus 9-healthy mother with no underlying diseases such as overt diabetes, gestational diabetes and preeclampsia
Exclusion criteria: 1-mothers who received analgesics prior to conducting intervention 2-mothers who needs emergency cesarean section
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
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
Shiraz University of Medical Sciences
Street address
Zand Avenue
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
CT-P-91-4395
Health conditions studied
1
Description of health condition studied
labour pain
ICD-10 code
O30-O48
ICD-10 code description
Maternal care related to the fetus and amniotic cavity and possible delivery problems
Primary outcomes
1
Description
duration of labour
Timepoint
Immediately after intervention
Method of measurement
Questionnaire
2
Description
Severity of pain
Timepoint
Before and immediately after the intervention
Method of measurement
Visual analogue pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: The acupuncture was conducted in intervention group after initiation of the active phase of labor defined by cervical dilatation of at least 4 centimeters and uterine contractions at least 3, each lasting for more than 40 seconds within 10 minutes. Intervention was done for 20 minutes in LI-4 and SP-6 points using C-type acupuncture needles (Seirin GMBH, Neu-Isenburg, Germany). SP-6 point is located four finger width above the medial malleolus on the posterior border of the tibia. LI-4 point is located on the dorsum of the hand, between the 1st and 2nd metacarpal bones, in the middle of the 2nd metacarpal bone on the radial side. Intervention was performed until patient reported sensation of tingling, numbness or warmth, and then rotated clock-wise every 5 minutes.
Category
Treatment - Other
2
Description
Intervention 2: In the control group, sham acupuncture was performed by superficial contact of needles in the mentioned points (LI4 and Sp6).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Avenue
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Maharlouei
Position
Assistant Professor
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3230 9615
Fax
Email
maharluei@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 3627 8791
Fax
Email
nasadi2012@yahoo.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Maharlouei
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 71 3230 9615
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)