Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity during insertion of spinal needle and time of anesthesia in patients under spinal anesthesia
Objectives: The purpose of this study is to examine the effects of Transcutaneous Electrical Nerve Stimulation on the severity of pain during insertion of spinal needle and time of anesthesia in patients under spinal anesthesia. This study is a clinical trial, double blind with randomization by Closed envelop that 60 patients will be divided in two groups: intervention and placebo. Inclusion criteria include: The patients who have 20 to 40 years old; weight of patients less than 100 kg; Ability to speak and understand the Persian language. Exclusion criteria include:The redness and burning sensation at the site of electrode; the incidence of cardiac arrhythmia. TENS electrodes are placed above and below the spinal needle of entrance area. In the intervention group, the TENS is set with 60 Hz and in the placebo group, TENS is inactive. Immediately after entering the spinal needle, pain intensity measured by VAS scale in two groups. Frequency changes to 10 Hz in the intervention group and continues until the end of surgery. Numbness and immobility duration is compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032727819N3
Registration date:2017-05-19, 1396/02/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-19, 1396/02/29
Registrant information
Name
Rasool Kawyan Nejad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9697
Email address
r.kaviannezhad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice– Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity during insertion of spinal needle and time of anesthesia in patients under spinal anesthesia
Public title
Effect of Transcutaneous Electrical Nerve Stimulation on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non-use of analgesic and sedative drug before surgery; The patient's ability to understand the pain score and answer questions; weight of patients less than 100 kg; age 20 to 40 years old; no pregnancy. Exclusion criteria: pain in other areas; history of dangerous arrhythmia and pacemaker; a skin problem at the site of the electrodes; injection analgesic and sedation drugs during spinal anesthesia.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Kermanshah University of Medical Sciences
Street address
Building No. 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
Postal code
6715847141
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.kums.REC.1395.762
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
2
Description of health condition studied
Immobility
ICD-10 code
R26.3
ICD-10 code description
Immobility
3
Description of health condition studied
Numbness
ICD-10 code
R20.2
ICD-10 code description
Numbness of skin
Primary outcomes
1
Description
Pain after spinal needle insertion
Timepoint
Immediately after entering the spinal needle
Method of measurement
VAS scale
2
Description
The duration of anesthesia
Timepoint
Until the time of return of lower extremity sense
Method of measurement
The duration of anesthesia is measured in minutes
3
Description
The duration of immobility
Timepoint
Until the time of return of lower extremity mobility
Method of measurement
Immobility time is measured in minutes
Secondary outcomes
empty
Intervention groups
1
Description
The duration of anesthesia is measured in minutes Intervention group: TENS electrodes are placed on areas of up and down needle insertion. TENS frequency of 60 Hz is set and then changes to 10 Hz.
Category
Treatment - Devices
2
Description
Placebo group: TENS electrodes are placed on areas of up and down needle insertion. TENS is inactive.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza of Hospital
Full name of responsible person
Javad Aminisanam
Street address
Emam Reza of Hospital, Bagh e Abrisham
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Behroz Hamze
Street address
Building No. 2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Rasool Kaviannezhad
Position
faculty member
Other areas of specialty/work
Street address
School of Paramedical, Davlat Abad Blvd
City
Kermanshah
Postal code
Phone
+98 83 3827 9697
Fax
Email
r.kaviannezhad@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasool Kaviannezhad
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
School of Paramedical, Davlat Abad Blvd
City
Kermanshah
Postal code
Phone
+98 83 3827 9697
Fax
Email
r.kaviannezhad@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasool Kaviannezhad
Position
Faculty member
Other areas of specialty/work
Street address
School of Paramedical, Davlat Abad Blvd
City
Kermanshah
Postal code
Phone
+98 83 3827 9697
Fax
Email
r.kaviannezhad@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)