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Determining and Comparing the Effect of Transcutaneous Electrical Nerve Stimulation at various points on pain intensity and satisfaction in patients undergoing cesarean section

Protocol summary

Summary
As a single-center, randomized, double-blind study, this research aims to examine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity and satisfaction in patients undergoing cesarean section. The population consists of 18-45-year-old women undergoing cesarean section with general anesthesia. The inclusion criteria employed in this paper are the risk of anesthesia ASA Class 1, no history of anticonvulsants, opiates or painkiller usage, lack of pacemaker, no wound in the locations where electrodes are applied, no local anesthesia at the incision site and no discharge in less than 24 hours. 296 subjects are divided into four groups including group I (positioning electrodes at ST36 and stimulating), group II (placement of electrodes at 3 to 4 cm around the incision), group III (positioning electrodes at ST36 without stimulation) and group IV (without placement of electrodes). The type of anesthesia drug is the same in 4 groups. Patients' pain is measured immediately after consciousness by VAS. TENS machine with a fixed frequency of 2.5 Hz is used. Electrical stimulation is performed in two stages, each of which takes 30 minutes at 2-3 hour intervals. Then, postoperative pain is measured at the end of stage 1, before and after stage 2 and at the end of the first 24 postoperative hours. Patient satisfaction and doses of painkilles are compared between 4 groups 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062222866N1
Registration date: 2015-09-14, 1394/06/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-14, 1394/06/23
Registrant information
Name
Nasrin Fadaee Aghdam
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23323395054
Email address
fadae@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences- Vice Chancellor for Research Affairs
Expected recruitment start date
2015-08-21, 1394/05/30
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and Comparing the Effect of Transcutaneous Electrical Nerve Stimulation at various points on pain intensity and satisfaction in patients undergoing cesarean section
Public title
The effect of Transcutaneous Electrical Nerve Stimulation (TENS) at various points on pain intensity and satisfaction in patients undergoing cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: 18 to 45 year-old women; the risk of anesthesia ASA Class 1(patients without any experience of organic, biochemical, physiologic or psychiatric disorders); no history of anticonvulsants; opiates or painkillers usage; lack of pacemaker; no wound in the locations where electrodes are applied; no local anesthesia at the incision site; no previous use of TENS and no discharge in less than 24 hours.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 296
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences. Vice Chancellor for Research Affairs
Street address
Hafte-Tir Square. Shahroud University of Medical Sciences Shahroud
City
Shahroud
Postal code
Approval date
2014-01-29, 1392/11/09
Ethics committee reference number
IR.SHMU.REC.1394.20

Health conditions studied

1

Description of health condition studied
Cesarean pain
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
Pain intensity
Timepoint
Immediately after consciousness, at the end of stage 1(after stimulation) , before and after stage 2( 2-3 h after the first stage) and after the first postoperative 24 hours
Method of measurement
Visual Analogue Scale (VAS) and scored from 0 to 10

Secondary outcomes

1

Description
Satisfaction
Timepoint
24 hours after caesarean section
Method of measurement
Visual Analogue Scale (VAS) and scored from 0 to 10

2

Description
Doses of painkillers
Timepoint
24 hours after surgery
Method of measurement
recording the type and frequency of the drugs used

Intervention groups

1

Description
group 1: placement of electrodes with stimulation at ST36 or Zusanli point (one finger width lateral from the anterior border of the tibia )
Category
Prevention

2

Description
group 2: placement of electrodes in 3 to 4 cm around the incision with electrical stimulation
Category
Prevention

3

Description
group 3: placement of electrodes at ST36 without electrical stimulation
Category
Prevention

4

Description
Group 4: without placement of electrodes
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Nasrin Fadaee Aghdam
Street address
Hafte-Tir Square, shahroud University of Medical Sciences , School of Nursing and Midwifery
City
shahruod

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian, PhD
Street address
Hafte-Tir Square, Vice Chancellor for Research, Shahroud University of Medical Science
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Nasrin Fadaee Aghdam
Position
Faculty member
Other areas of specialty/work
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences , School of Nursing and Midwifery
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
fadae@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Ebrahimi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences , School of Nursing and Midwifery
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
h_ebrahimi43@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nasrin Fadaee Aghdam
Position
Faculty member
Other areas of specialty/work
Street address
Hafte-Tir Square, shahroud University of Medical Sciences , School of Nursing and Midwifery
City
Shahroud
Postal code
Phone
+98 233239505
Fax
Email
fadae@shmu.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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