The Effects of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Zusanli) on Pain and Agitation Reduction under Ventilator ICU Patients
Objectives: This study aimed to investigate the effect of Percutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Zusanli) on pain and agitation in intubated patients under ventilator will be carried out.
Design:50 patients with inclusion criteria (having a tracheal tube, patients with pneumonia, non-smoking) in two groups of case and controls (including active TENS and placebo TENS) using a table of random numbers are divided.
Variables the severity of pain and agitation is measured by COPT and Richmond Scale will be assess before and after in two groups and As well as Narcotic and sedation consumption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050927819N1
Registration date:2017-02-10, 1395/11/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
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
2017-02-19, 1395/12/01
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
The Effects of Transcutaneous Electrical Nerve Stimulation (TENS) in Acupuncture Points (Hegu and Zusanli) on Pain and Agitation Reduction under Ventilator ICU Patients
Public title
The Effects of Transcutaneous Electrical Nerve Stimulation (TENS)on Pain and Agitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having endotracheal tube; Pneumonia patients requiring mechanical ventilation; aged 30 to 50; Placement of electrodes is healthy skin; Blood pressure> 100Hg; Non-zero score on scale of COPT; Non-zero score on scale of Richmond; No smoking or narcotic; New Admission in ICU; 10)GCS>7
Exclusion criteria: Conditions prohibiting the use of TENS (such as pacemakers, because of the unknown effects of TENS on electrical conduction system or placing the electrode directly on open wounds); Obesity (weight more than 100 pounds); Skin infection or severe skin disease in the place of the electrodes; Pregnancy
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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 Science, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
6715847141
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
IR.kums.REC.1395.533
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R45.4
ICD-10 code description
Irritability and anger
2
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Per 2 hours untill two day
Method of measurement
using the scale of Critical-Care Pain Observation Tool(CPOT)
2
Description
Agitation
Timepoint
Per 2 hours untill two day
Method of measurement
using the scale of Richmond
Secondary outcomes
1
Description
The amount of Narcotic used
Timepoint
48 hourse
Method of measurement
microgram
2
Description
The amount of sedation used
Timepoint
48 hourse
Method of measurement
miligram
Intervention groups
1
Description
TENS devices active: Case group
TENS electrodes are placed on points Hego and zosunli .Then the TENS is turned on with frequency 1-10 Hz and 20-50 mA to using for 30 minutes three times a day. pain and agitation severity is measured per 2 hours by researchers.
Category
Treatment - Devices
2
Description
TENS device disabled: control group
TENS electrodes are placed on points Hego and zosunli . Then the TENS is turned off to using for 30 minutes three times a day. pain and agitation severity is measured per 2 hours by researchers.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Javad Aminisaman
Street address
Emam-Reza Hospital, Bagh-e Abrisham
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs of 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 – Chancellery of Research & Technology Affairs of 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 Scienes
Full name of responsible person
Rasool Kaviannezhad
Position
faculty member
Other areas of specialty/work
Street address
School of Paramedical, DavlatAbad 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, DavlatAbad 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, DavlatAbad Blvd
City
Kermanshah
Postal code
Phone
+98 83 3827 9697
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)