The aim of this study is to determine the effectiveness of various types of Transcutaneous Electrical Nerve Stimulation on the severity of postoperative pain in orthopedic patients
Design
In this research, 50 eligible patients referring to Khatam Hospital of Zahedan were chosen purposefully and a envelope was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This single-step non-blinded clinical trial was done on 160 patients with orthopedic surgeries at Khatam Hospital of Zahedan.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Over 18 years of age; Not having pacemakers and dangerous arrhythmia during a clinical trial; Not taking narcotic drugs 6 hours before the intervention; 24 hours past the surgery.
Exclusion criteria include: Intolerance to the device
Intervention groups
The study in four groups of: control with 40 subjects, The control group received routine care. The intervention group was affected by TENS method for 30 minutes; The High group with a frequency of 100 Hz and an intensity of 10-30 MA; Low group at a frequency of 10 Hz, and an intensity of 20-50 MA, and in the burst group 1-2 set of electric pulses with a frequency of 100 Hz and low intensity are applied on the patient, expressing pain.
Main outcome variables
En Pain as an unpleasant psychosomatic experience has been always a challenge for health care providers. Nurse are the essential pillars for assessing and managing pain. In this study, we evaluate pain control in orthopedic patients by non-pharmacological methods.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036612N2
Registration date:2017-12-01, 1396/09/10
Registration timing:prospective
Last update:2017-12-01, 1396/09/10
Update count:0
Registration date
2017-12-01, 1396/09/10
Registrant information
Name
Simin Sharifi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+54 33442481
Email address
sharifi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
• Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation in Control the pain intensity of postoperative Orthopedic patients
Public title
"Effect of Transcutaneous Electrical Nerve Stimulation in pain controlling Orthopedic Patients"
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All orthopedic patients more than 18 years old, who have pain after orthopedic surgery
Exclusion criteria:
Having a pacemaker and Cardiac arrhythmia
pregnant women
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized study method is simple random. The method will be used to refer to the orthopedic section of the available samples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Ganat Blvd , Zahedan _ Iran, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.ZAUMS.REC.1396;151
Health conditions studied
1
Description of health condition studied
The Relationship of Effect of Nervous-Stimulated Nervous Stimulation on the Control of Post-Operative Orthopedic Patients' Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before intervention immediately after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The HIGH TENS group in this group uses the Total TENS EMS 2015 to set the frequency to 100 Hz and intensity of 10-30 MA. For each person only once, for 30 minutes. To stimulate, place the device's electrodes 10 cm on both sides of the lesion.
Category
Other
2
Description
Intervention group 2: The LOW TENS group in this group uses the Total TENS EMS 2015 device to set the frequency to 10 Hz and the intensity of 50-20 mA. For each person only once, for 30 minutes. To stimulate, place the device's electrodes 10 cm on both sides of the lesion.
Category
Other
3
Description
Intervention group 3 : The BURST group in this group uses the Total TENS EMS 2015 device to set the settings to 1_2 pulse circuits with a frequency of 100 Hz and low current. For each person only once, for 30 minutes. To stimulate, place the device's electrodes 10 cm on both sides of the lesion.
Category
Other
4
Description
Control group: routine care is provided to control patient's pain
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Hospital in Zahedan
Full name of responsible person
Motahareh Farshad Faghih
Street address
Zahedan_ Jame Jam blv, Khatam Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
Motahareh_farshadfaghih@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Noor Mohamad Bakhshay
Street address
Ganat Blvd , Zahedan _ Iran, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Motahareh Farshad Faghih
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Mirzadeh Dead End, Emam Khomeini st, Rasht_Iran
City
Rasht
Province
Guilan
Postal code
4137616579
Phone
+98 31 3332 8590
Fax
Email
motahareh_farshadfaghih@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Simin Sharifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Behdasht blv, Zahedan Faculty of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 543425765
Fax
Email
siminsharifi1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Motahareh Farshad Faghih
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 20, Mirzadeh Dead End, Emam Khomeini st, Rasht_Iran
City
Rasht
Province
Guilan
Postal code
4137616579
Phone
+98 31 3332 8590
Fax
Email
motahareh_farshadfaghih@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available