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IRCT20240123060780N1 IRCT 2024-01-27 Kermanshah University of Medical Sciences Stimulation of cathodic, anodic, alternating current and EMLA anesthetic ointment on pain level and comfort in painful hospital procedures The comparison of using cathodal, anodal direct current stimulation and intermittent with combined analgesia ointment of lidocaine and prilocaine on pain and comfort levels in arterial, vein blood sampling and intramuscular injection processes 2024-02-09 anticipated 200 Complete https://irct.ir/trial/75119 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of samples in this study is done by computer software. A random sequence of letters A, B, C, D (for the intervention groups) and E (for the control group) is made in blocks with a random number of 6 and 8 letters. Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally the patient is placed in one of the intervention or control groups, Blinding description: In the control group, the connection of the electrode to the skin and the needle head is studied, but the device is in inactive mode. Also, a non-effective gelatinous substance (lubricant gel) (similar to the pharmaceutical form of EMLA anesthesia ointment) is used in the control group. In the group receiving anesthetic ointment, anesthetic ointment is placed on the injection or sampling site, and electrodes without electrical stimulation function are also used. Active electrodes of electrical stimulation are used in different groups of electrostimulation devices, but gelatinous substance without effect (lubricant gel) is also used. Therefore, due to the seemingly identical interventions, patients do not know grouping and the type of stimulation interventions. Also, the co-colleague of the variable registration project does not know the type of grouping. 3 Pain. Intervention 1: Intervention group; patients in this group receive anodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. tip entry area. Intervention 2: Control group; Patients in this group receive lidocaine (2.5%) and prilocaine (2.5%) local anesthetic ointment in the area of the needle tip one hour before the procedures. Intervention 3: Intervention group; patients in this group receive cathodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. Intervention 4: Intervention group; patients in this group receive alternating current stimulation (1-5 mA) with a frequency of 50 Hz at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Rasoul Kavyannejad
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 r.kavyannejad@kums.ac.ir Kermanshah University of Medical Sciences scientific Rasoul Kavyannejad
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 r.kavyannejad@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Full consciousness, literacy, reading, writing, verbal ability and healthy vision, no addiction, the skin of the study area should be healthy, no peripheral edema in the intervention area, not taking sedatives and anesthetic during the last 24 hours, not having a pacemaker and implantable cardiac device and defibrillators, no history of diabetes and vascular diseases. 30 years 60 years Both G89.1 Acute pain, not elsewhere classified Treatment - Devices Treatment - Drugs Treatment - Devices Treatment - Devices Intervention group; patients in this group receive anodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. tip entry area Control group; Patients in this group receive lidocaine (2.5%) and prilocaine (2.5%) local anesthetic ointment in the area of the needle tip one hour before the procedures. Intervention group; patients in this group receive cathodal direct current stimulation (1-5 mA) at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. Intervention group; patients in this group receive alternating current stimulation (1-5 mA) with a frequency of 50 Hz at the same time as the needle tip enters the skin. Electrical stimulation is performed by connecting the active electrode to the needle tip. The other electrode is connected to the skin in the area far from the needle entry. Pain. Timepoint: Immediately and in minutes 1, 3 and 5. Method of measurement: The visual analog scale. Comfort level. Timepoint: 5 minutes after each procedure. Method of measurement: The visual analog scale. Heart rate. Timepoint: Before, immediately and in 1,3,5 minutes. Method of measurement: Using portable pulse oximetry. Kermanshah University of Medical Sciences Approved 2024-01-16 Ethics committee of Kermanshah University of Medical Sciences No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)