The comparison of effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients
Introduction: Pain is one of the most problematic in human experiences that is peak of physical and psychological problems. Experience of pain during needle insertion is unavoidable in hemodialysis settings and patients explain it as a worst experience during hemodialysis. It is important to find interventions for pain relief during the needle insertion in hemodialysis patients. Aim: The comparison of effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients. Method: Thirty hemodialysis patients of hemodiaysis ward who are eligible are selected. Four interventions including TENS, Placebo-TENS, Lidocain spray, Lidocain placebo spray are performed for any patient in sequential sessions of hemodialysis with randomly assignment before the arterial needle insertion. The severity of pain during arterial needle insertion is measured by “Numeric Pain Intensity Scale”. The Friedman test is used for evaluation of difference among means the severity of pain in four different conditions.
General information
Acronym
TENS
IRCT registration information
IRCT registration number:IRCT201008254548N1
Registration date:2010-11-13, 1389/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-11-13, 1389/08/22
Registrant information
Name
Nahid Hoshmand motlagh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3105 2114
Email address
hoshmand@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients
Public title
The effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (1) The patient be alert, (2) The patient does not intake analgesic and narcotic drugs before 6 hours, (3) Not to have any pain in other parts of body, (4) Not to have internal cardiac pacemaker, (5) The patient must have arterio-venous fistula for veonous access. Exclusion criteria: (1) To attend the study is completely optional, So the patient can avoid from study whenever he/she want, without any change in personnel’s behavior or care, (2) At the first action, if the patient 's vessels are not achievable , he/she is omitted from study, (3) patients who are in the low consciousness and cognition condition and could not answer the questions, (4) If the patient is transferred to other centers during studying.
Age
From 10 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Nursing and Paramedicine Faculty، Semnan University Of Medical Sciences
City
Semnan
Postal code
35131038111
Approval date
2010-08-24, 1389/06/02
Ethics committee reference number
5513/1/3
Health conditions studied
1
Description of health condition studied
chronic renal failure
ICD-10 code
N180
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Intensity pain
Timepoint
One minute after entering the arterial needle
Method of measurement
Numeric Pain Intensity Scale
Secondary outcomes
empty
Intervention groups
1
Description
Fourth intervention (TENS placebo): TENS is turned off and researcher place TENS electrodes with 6 centimeter distance from each other on the skin near the location of insertion of arterial needle. One minute after to place TENS electrodes on the skin, whereas TENS is turn off so, hemodialysis needle (gaoge 16) is inserted into vascular in fistula area by dialysis ward nurse. One minute later, the pain severity is measured with Numeric Pain Intensity Scale by nurse.
Category
Placebo
2
Description
First intervention (TENS): TENS electrodes are placed on the skin with 6 centimeter distance from each other near the location of insertion of arterial needle by researcher. Then the TENS is turned on with frequency 100 Hz and pulse duration 0/1msec by researcher. One minute after using TENS, hemodialysis needle (gaoge 16) is inserted into vascular in fistula area by dialysis ward nurse. One minute later, the pain severity is measured with Numeric Pain Intensity Scale by nurse.
Category
Treatment - Devices
3
Description
Second intervention (lidocaine placebo spray): Lidocaine placebo spray is water that is filled in emptied lidocaine spray bottle. 2 puffs are used from distance 5 centimeter on the skin in location of needle insertion by researcher. 5 minutes later, hemodialysis needle (gaoge 16) is inserted by dialysis ward nurse.
Category
Placebo
4
Description
Third intervention (lidocaine spray): 2 puffs of lidocaine 10% spray (each puff include 10mg lidocaine) are used from distance 5 centimeter on the skin in location of insertion of arterial needle by researcher. 5 minute later, hemodialysis needle (gaoge 16) is inserted by dialysis ward nurse. One minute later, the pain severity is measured with Numeric Pain Intensity Scale by nurse.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Nahid Hoshmand Motlagh
Street address
Hefdah Shahrivar Blvd
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Raheb Ghorbani (Ph.D)
Street address
Semnan University of Medical Sciences and Health Services, Basij Blvd
City
Semnan
Grant name
اعتبارات پژوهشي دانشگاه علوم پزشكي
Grant code / Reference number
441
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University Of Medical Sciences
Full name of responsible person
Nahid Hoshmand Motlagh
Position
Postgraduate student
Other areas of specialty/work
Street address
Nursing and Paramedicine Faculty, Semnan University Of Medical Sciences
City
Semnan
Postal code
35131038111
Phone
+98 32 1335 4191
Fax
+98 23 1335 4190
Email
Hoshmand@sem-ums.ac.ir
Web page address
www.sem-ums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University Of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Position
PhD
Other areas of specialty/work
Street address
Nursing and Paramedicine Faculty, Semnan University Of Medical Sciences
City
Semnan
Postal code
35131038111
Phone
+98 23 1335 4191
Fax
+98 23 1335 4190
Email
Asgari@Sem-Ums.ac.ir
Web page address
www.sem-ums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan Universiyt OF Medical Sciences
Full name of responsible person
Nahid Hoshmand Motlagh
Position
Postgraduate student
Other areas of specialty/work
Street address
Nursing and paramedicine Faculty, Semnan university Of Medical sciences
City
Semnan
Postal code
35131038111
Phone
+98 23 1335 4191
Fax
+98 23 1334 5190
Email
hoshmand@sem-ums.ac.ir
Web page address
www.sem-ums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)