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IRCT201008254548N1 IRCT 2010-11-13 Semnan University of Medical Sciences The effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients TENS The comparison of effect of Transcutaneous Electrical Nerve Stimulation (TENS) and lidocaine spray on pain intensity during insertion of vascular needles in hemodialysis patients 2010-09-23 anticipated 30 Complete https://irct.ir/trial/4851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive. N/A chronic renal failure. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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.
public Nahid Hoshmand Motlagh
Nursing and Paramedicine Faculty, Semnan University Of Medical Sciences
Semnan Iran (Islamic Republic of) 35131038111 +98 32 1335 4191 Hoshmand@sem-ums.ac.ir Semnan University Of Medical Sciences scientific Mohammad Reza Asgari
Nursing and Paramedicine Faculty, Semnan University Of Medical Sciences
Semnan Iran (Islamic Republic of) 35131038111 +98 23 1335 4191 Asgari@Sem-Ums.ac.ir Semnan University Of Medical Sciences Iran (Islamic Republic of) 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. 10 years 100 years Both N180 End-stage renal disease Placebo Treatment - Devices Placebo Treatment - Drugs 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. 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. 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. 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. Intensity pain. Timepoint: One minute after entering the arterial needle. Method of measurement: Numeric Pain Intensity Scale. Semnan University of Medical Sciences Approved 2010-08-24 Semnan University of Medical Sciences Nursing and Paramedicine Faculty، Semnan University Of Medical Sciences Semnan Iran (Islamic Republic of)