The aim of this study is to determine the effect of percutaneous electrical nerve stimulation on labor pain. This study is a clinical trial with random allocation that samples will be divided in three group: intervention, placebo and control . Inclusion criteria will be: Nulliparous women; singleton; cephalic; gestational age 38-42 week; active phase; intact membranes. Exclusion criteria : Intra Uterine growth Restriction; cesarean indication ; medical and obstetric disease; experience of using Transcutaneous Electrical Nerve Stimulation ; skin irritation in place of electrodes; chronic disease; fetal distress.
In 4 dilatation before insert Transcutaneous Electrical Nerve Stimulation device pain severity will be assessed by pain numerical scale. Then Transcutaneous Electrical Nerve Stimulation electrode will be insert .After that patient's pain will be assessed every one hour till end of first stage of childbirth , second stage and 4 hours after childbirth. Duration of first and second stage of labor will be checked. In placebo group electrodes insert in the same place of intervention group but it will not be on. In control group there is not any intervention and patients received routine care . In placebo and control groups, stage duration and severity pain will be assessed as the intervention group.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016020914556N3
Registration date:2017-01-10, 1395/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
Roonak Shahoei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 1120
Email address
roonak.shahoei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kurdistan University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transcutaneous Electrical Nerve Stimulation on labor pain among nulliparous women
Public title
Effect of Transcutaneous Electrical Nerve Stimulation on labor pain among nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous women referred to birth ward of Beasat hospital ; singleton;cephalic; gestational age 38-42 week; active phase;intact membranes
Exclusion criteria : Intra Uterine growth Restriction;cesarean indication ; medical and obstetric disease; experience of using Transcutaneous Electrical Nerve Stimulation ; skin irritation in place of electrodes; chronic disease; fetal distress.
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Closed envelop will be used for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Passdaran Street- Kurdistan university of Medical Sciences- Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
muk.rec.1394
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Labor pain severity
Timepoint
First and second stage of labor and four hour after birth
Method of measurement
Numerical pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In 4 dilatation of cervix before using TENS, the severity of pain will be assessed by numerical scale. Then transcutaneous electrical nerve stimulation electrodes will be insert between 10th thoracic to lumbar first from 5 cm in middle line. Also 2 electrodes will be insert among second to fourth sacrum vertebral with the same interval. After that TENS will be on and intensity increase till the mother express tingling in the site of electrodes and the flow will be fixed. Then every one hour till end of first stage , during second stage and four hours after labor mother pain with numerical scale will be assessed and recorded. Also duration of first and second stage of laber will be recorded.
Category
N/A
2
Description
Placebo: In this group electrodes will be inserted as same as places of intervention group but the device will be off.
Category
N/A
3
Description
Control group: In this group there is not any intervention , just routine care will be done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital of Sanandaj- Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Street address
Pasdaran Street, Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Kurdistan University of Medicak Sciences
Full name of responsible person
Dr Rezaei
Street address
Pasdaran Street, Kurdistan University of Medical Sciences
City
Sanandaj
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,Kurdistan University of Medicak 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
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
Associate professor/ PhD
Other areas of specialty/work
Street address
Pasdaran Street, Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Postal code
66166
Phone
+98 876661120
Fax
Email
rshaho@yahoo.com
Web page address
muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD/ Associate Professor
Other areas of specialty/work
Street address
Pasdaran Street, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Postal code
66166
Phone
+98 876661120
Fax
Email
rshaho@yahoo.com
Web page address
muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Pasdaran Street, Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Postal code
66166
Phone
+98 876661120
Fax
Email
rshaho@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)