The effect of transcutaneous electrical nerve stimulation (TENS) on intensity of labor pain in active parturition phase in pregnant women that refer to Dezyani Hospital on 2010
The aim of this study is evaluation the effect of transcutaneous electrical nerve stimulation for decrease of labor pain.This clinical trial was done on one hundred forty four (144) pregnant women in active phase of parturition that refer to Dezyani hospital that based on inclusion criteria: Primiparous, single term pregnancy, cephalic presentation, 3-5 cm dilatation, maternal age between 20-40 years and exclusion criteria: maternal cutaneous on the application site such as wound scar؛ pacemaker.The samples were collected after filling the questionnaire and recording the demographic at random. The severity of labor pain was evaluated with visual analogue scale (VAS) in the TENS, TENS placebo and control groups immediately after intervention, 30 minute after intervention and 60 minute after intervention. This examination was done in 5-6 cm and 8-9 cm dilatation and was analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205059642N1
Registration date:2012-10-31, 1391/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-31, 1391/08/10
Registrant information
Name
Elham Mobasheri
Name of organization / entity
Golestan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1222 5012
Email address
mobasheri@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University Of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-16, 1389/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of transcutaneous electrical nerve stimulation (TENS) on intensity of labor pain in active parturition phase in pregnant women that refer to Dezyani Hospital on 2010
Public title
The effect of transcutaneous electrical nerve stimulation (TENS) on intensity of labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: primiparous؛ term pregnancy؛cephalic presentaition؛at active phase of the first stage of labor with cervical dilataion3-5 cm; age between 20-40 years-
exclusion criteria: maternal cutaneous on the application site such as wound scar; pacemaker user
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:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University Of Medical Sciences
Street address
Shast kolah Road,Golestan University Of Medical Sciences -Gorgan
City
Gorgan
Postal code
Approval date
2010-08-29, 1389/06/07
Ethics committee reference number
1465
Health conditions studied
1
Description of health condition studied
labor pain in active parturition phase
ICD-10 code
O80.9
ICD-10 code description
delivery(single)normal
Primary outcomes
1
Description
labor pain in active phase
Timepoint
Measurement of pain,right after intervention,30minutes,60minutes after intervention
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Trial group: used the Tens on back (L1-T10)
Category
Treatment - Other
2
Description
Tens plasebo group: group received no electrical stimulation
Category
Placebo
3
Description
control group: no Intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezyani Hospital
Full name of responsible person
Mersede kia
Street address
Beheshti Street, Dezyani Hospital, Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University Of Medical Sciences
Full name of responsible person
Dr.Arabi
Street address
Beheshti Street, Dezyani Hospital, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University Of Medical Sciences
Full name of responsible person
Mersedeh Kia
Position
Assistant Of Obsterics And Gynecology
Other areas of specialty/work
Street address
Golestan University Medical Of Sciences, Shast kolah Road, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 5012
Fax
Email
ml7.sedehi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Obstetrics and Gynecology
Full name of responsible person
Elham Mobasheri
Position
Gynecologist
Other areas of specialty/work
Street address
Beheshti Street, Dezyani Hospital, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 5012
Fax
Email
mobasheri@goums.ac.irml7.sedehi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University Of Medical Sciences
Full name of responsible person
Mersede kia
Position
Assistant
Other areas of specialty/work
Street address
Beheshti street, Dezyani Hospital, Gorgan
City
Gorgan
Postal code
4916694667
Phone
+98 17 1222 5012
Fax
Email
ml7.sedehi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)