Aim:This study was to investigate the influence of TENS (Transcutaneous Electrical Nerve Stimulation) in pain controlling while change dressing in hospitalized burned patients.Inclusion criteria All of patients that have 70-15 age old years with grade 2 of burn in hands and legs.
Materials and Methods: This is a clinical trial study that 60 hospitalized burned patients to burn part in Sabzevar Vasee hospital in 1393. The patients divided simply randomize to three group control (20 peoples), case (20 peoples) and placebo (20 peoples). To third bedridden, takes morphine in group control, TENS with morphine in case group and placebo TENS with morphine in placebo group before beginning change dressing and then changed dresses. Finally after change dressing assessed intensity of patient’s pain according to, pain numeric scale 0-10.
General information
Acronym
TENS(Transcutaneous Electrical Nerve Stimulation)
IRCT registration information
IRCT registration number:IRCT2014101719561N1
Registration date:2015-03-17, 1393/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-17, 1393/12/26
Registrant information
Name
mohammad Siavoshi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 6621
Email address
siavoshi.m1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar univercity of medical science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness using of TENS (Transcutaneous Electrical Nerve Stimulation) in pain controlling while change dressing in hospitalized burned patients
Public title
Effectiveness using of TENS (Transcutaneous Electrical Nerve Stimulation) in pain controlling while change dressing in hospitalized burned patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All of patients with Superficial and deep by grade 2 of burn; The consciousness burned patients to 4-20 range percent; The patients that have 15-70 age old; The burned patients in upper or lower or upper and lower members. Exclusion criteria: The mental retardation patients that don’t talk measure of numeric pain scale; The burned patients less of 4 and more of 20 percent; The pregnant patients (special in third of pregnancy); The patients with heart disorders or have a pace maker; The patients with sensibility to gel; The patients that have an epilepsy.
Age
From 15 years old to 70 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Science
Street address
Tehran road-side the road police-Sabzevar University of Medical Science
City
Sabzevar
Postal code
9613846776
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
medsab.Rec.93.4
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
pain
Timepoint
while intervention(in third days of hospitalization)
Method of measurement
measure of numeric pain scale
Secondary outcomes
1
Description
skin sensivity to TENS
Timepoint
after of end intervention
Method of measurement
observation
Intervention groups
1
Description
Control Group: Before washing the patient’s lesions and exchanging the bandage, 5 mg of Morphine ampoule is infusion and we start to exchange the bandage 15 minutes later and at the last, the Patient’s pain level is asked and recorded from the patient on the base of 0-10 pain numerical scale.
Category
Treatment - Drugs
2
Description
Intervention Group: Before washing the patient’s wounds and exchanging the dress, infusion Morphine ampoule for 5 mg and we start to exchange the bandage 15 minutes later. Morphine ampoule was infusion before exchanging the dress and then, leads of TENS device were connected to Distal of burned organ and later, we turn on the device and 60-100 HZ frequency rate and 10-30 mA amperage are given and then, we begin to washing and exchanging the bandage and again the patient’s pain level during the dress exchange is asked and recorded at the end.
Category
Treatment - Devices
3
Description
Placebo Group: Before washing the patient’s wounds and exchanging the dress, 5 mg of Morphine ampoule is infusion and we start to exchange the dress 15 minutes later. Morphine ampoule was infusion before exchange the dress and then, leads of Tens device were connected to Distal of burned organ and later, we turn on the TENS device but no frequency is given and then, we begin to washing and exchanging the dress and again the patient’s pain level during the dress exchange is asked and recorded at the end.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
part burn of sabzevar hospital Vasee
Full name of responsible person
Mohammad Siavoshi
Street address
Vasee hospital
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mosareza Tadayonfar
Street address
Vasee Hospital
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Science
Full name of responsible person
Dr. Mahtab Khajeh
Position
General Surgeon/Responsible of Sabzevar part burn
Other areas of specialty/work
Street address
Vasee hospital
City
Sabzevar
Postal code
9613984154
Phone
+98 51 4423 9605
Fax
+98 51 4464 5100
Email
mahtabkhajeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Mohammad Savoshi
Position
MSc Student, Department of Medical Surgical Nursing