The Effect of Using High Transcutaneous Electrical Nerve Stimulation (TENS) on the Severity of Pain, Nausea and Vomiting after Percutaneous Nephrolithotomy (PCNL)
The purpose of this study is to examine the effect of using High Transcutaneous Electrical Nerve Stimulation (TENS) on the severity of pain, nausea and vomiting after percutaneous nephrolithotomy. In this study, 72 patients who underwent percutaneous nephrolithotomy in Ghaem Hospital, is being examined. This clinical trial, includes three groups and is single blinded. Inclusion criteria include: The patients who have 15-70 age old; All of consciousness patients who have unilateral percutaneous nephrolithotomy surgery. Exclusion criteria include: Those due to uncontrollable nausea and vomiting may require medication; The incidence of adverse events recorded in the patient during surgery; Drug addiction. Patients are randomly divided into three groups: control (24 peoples), intervention (24 peoples) and placebo (24 peoples). After surgery, in the intervention group TENS with a frequency of 100 Hz, based on patient tolerance at a distance of 5 cm from the nephrostomy for 20 minutes twice with an interval of six hours is established. In the placebo group TENS unit is turned on, but with zero intensity and
frequency, i.e. no electrical stimulation. The severity of pain, nausea and vomiting before and after the intervention to be measured for 12 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112030989N1
Registration date:2017-01-25, 1395/11/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-25, 1395/11/06
Registrant information
Name
Radnoush Shadmehri
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1300
Email address
shadmehrir1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Using High Transcutaneous Electrical Nerve Stimulation (TENS) on the Severity of Pain, Nausea and Vomiting after Percutaneous Nephrolithotomy (PCNL)
Public title
The Effect of Using Transcutaneous Electrical Nerve Stimulation on the Severity of Pain, Nausea and Vomiting after Percutaneous Nephrolithotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patients who have 15-70 age old; All of consciousness patients who have unilateral percutaneous nephrolithotomy surgery; Ability to speak and understand the Persian language. Exclusion criteria: Those due to uncontrollable nausea and vomiting may require medication; The incidence of adverse events recorded in the patient during surgery; Drug addiction; Being blind; The patients with motion sickness; Digestive disorders associated with nausea and vomiting; Mental retardation or mental disorders and epilepsy; Pregnancy; Patients who have cardiac pacemaker.
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:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the permutation block method is used and patients are divided into three groups: control, intervention and placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Department of Education, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2016-10-15, 1395/07/24
Ethics committee reference number
IR.MEDSAB.REC.1395.78
Health conditions studied
1
Description of health condition studied
Surgery for kidney stones
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
pain
Timepoint
Before the intervention, immediately after intervention, 1, 2, 6 and 12 hours after intervention
Method of measurement
11–point Numeric Rating Scale
2
Description
Nausea
Timepoint
Before the intervention, immediately after intervention, 1, 2, 6 and 12 hours after intervention
Method of measurement
Visual Analog Scale
3
Description
Vomiting
Timepoint
After receiving TENS to 12 hours being counted.
Method of measurement
The vomiting and retching frequency form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgery, in the intervention group TENS with a frequency of 100 Hz, based on patient tolerance at a distance of 5 cm from the nephrostomy for 20 minutes twice with an interval of six hours is established. The severity of pain, nausea and vomiting before and after the intervention to be measured for 12 hours.
Category
Other
2
Description
In the placebo group TENS unit is turned on, but with zero intensity and frequency i.e. no electrical stimulation. The severity of pain, nausea and vomiting before and after the placebo TENS to be measured for 12 hours.
Category
Placebo
3
Description
In the control group, no intervention is applied. The severity of pain, nausea and vomiting before and after surgery to be measured for 12 hours.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Radnoush Shadmehri
Street address
Ahmad Abad street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Departman of research and technology, Building number one, next to the police station to SHahroud road, Sabzevar
City
Sabzevar
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 of 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 Sciences
Full name of responsible person
Radnoush Shadmehri
Position
MSc Student of Medical Surgical Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4401 1300
Fax
Email
shadmehrir1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hasan Khalili
Position
Faculty member of Medical Surgical Nursing group,MSc of Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4401 1300
Fax
Email
khalili894@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Radnoush Shadmehri
Position
MSc Student of Medical Surgical Nursing
Other areas of specialty/work
Street address
College of Nursing, Sabzevar University of Medical Sciences, Tohid Shahr Blvd, Sabzevar
City
sabzevar
Postal code
Phone
Fax
Email
shadmehrir1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)