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IRCT20230316057732N1 IRCT 2023-05-30 Mashhad University of Medical Sciences The Effect of using High Transcutaneous Electrical Nerve Stimulation on the severity of pain, nausea and vomiting after Percutaneous Nephrolithotomy The Effect of using High Transcutaneous Electrical Nerve Stimulation on the severity of pain, nausea and vomiting after Percutaneous Nephrolithotomy 2023-05-22 anticipated 72 Complete https://irct.ir/trial/69240 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This is done when eligible patients are eligible to enter the study based on the form Entry and exit criteria of the study, by random allocation method and using the permutation block method in three groups Control, test and placebo were included. In the replacement block method, according to the sample size, blocks of 3 people with Three codes A, B, C were defined and considering all possible substitutions, finally 6 substitutions and 24 The block was obtained. Patients according to the time of entering the ward after the surgery is done by block method They were placed in one of the control, test or placebo groups. For example, in the first ABC block people based on the time of entering the ward after surgery in the test group and the second person in the placebo group and no The third was placed in the control group. N/A Condition 1: Kidney stones. Condition 2: Nausea and vomiting. Condition 3: Pain. Intervention group: High Transcutaneous Electrical Nerve Stimulation In such a way that when admitting the patient in the ward, immediately after the patient's statement of pain, the intensity of pain and the intensity of nausea are evaluated and recorded using the relevant criteria. Then, the patient's skin at the location of the electrodes is cleaned with cotton dipped in alcohol and warm water for any secretions and grease, after that the electrodes are covered with disposable wet pads with a double layer with a one-sided layer covered with leather to prevent loss. The current of the device is connected to a distance of 5 cm from the area of ​​nephrostomy of the kidney undergoing surgery. Tens therapy was established for 20 minutes with a frequency of 100 Hz and the intensity of the current was based on the patient's tolerance. Then, immediately after turning off the device and at one and two hours, the severity of the patient's nausea is evaluated with a scaleAfter 6 hours, again after evaluating the intensity of pain and intensity of nausea, tennis therapy is established for 20 minutes with frequency of 100 Hz and intensity of current according to the patient's tolerance, and after turning off the device and at 7th, 8th, 12th and 18th hours, the intensity is again increased. Pain and severity of nausea are evaluated. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: All person Conditions: All researchers can perform the required analyzes under the condition of observing research ethics Where to obtain: Reza saberani dr.rsaber@gmail.com How to obtain: After sending the request by email to the responsible author Reza Sabrani Comments:
public Reza Saberani
No 135 baharestan 5 north khayam
Mashhad Iran (Islamic Republic of) 9199683342 +98 51 3706 0439 Dr.rsaber@gmail.com Mashhad University of Medical Sciences scientific Reza Saberani
No 135 baharestan 5 north khayam
Mashhad Iran (Islamic Republic of) 9199683342 +98 51 3706 0439 Dr.rsaber@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Consent to conduct the study Patients who are fully awake Patients aged 15 to 70 years Patients undergoing unilateral percutaneous kidney stone surgery Ability to understand and speak Persian 15 years 70 years Both Using a different anesthesia protocol than other patients Receive anti-nausea in recovery movement disorder Having a digestive disease that causes vomiting and nausea Patients with mental retardation suffering from the mental illness or epilepsy Pregnancy Having cardiac arrhythmia and having a pacemaker Any wound and deformity at the place of placement of electrodes Diabetic neuropathy neuralgia History of use and familiarity with TENS Receiving narcotics or anti-nausea medication before surgery Addiction to drugs or opium Blindness or visual impairment N20.0 R11 R52 Calculus of kidney Nausea and vomiting Pain, unspecified Rehabilitation Intervention group: High Transcutaneous Electrical Nerve Stimulation In such a way that when admitting the patient in the ward, immediately after the patient's statement of pain, the intensity of pain and the intensity of nausea are evaluated and recorded using the relevant criteria. Then, the patient's skin at the location of the electrodes is cleaned with cotton dipped in alcohol and warm water for any secretions and grease, after that the electrodes are covered with disposable wet pads with a double layer with a one-sided layer covered with leather to prevent loss. The current of the device is connected to a distance of 5 cm from the area of ​​nephrostomy of the kidney undergoing surgery. Tens therapy was established for 20 minutes with a frequency of 100 Hz and the intensity of the current was based on the patient's tolerance. Then, immediately after turning off the device and at one and two hours, the severity of the patient's nausea is evaluated with a scaleAfter 6 hours, again after evaluating the intensity of pain and intensity of nausea, tennis therapy is established for 20 minutes with frequency of 100 Hz and intensity of current according to the patient's tolerance, and after turning off the device and at 7th, 8th, 12th and 18th hours, the intensity is again increased. Pain and severity of nausea are evaluated Pain reduction. Timepoint: Before tens, immediately after the intervention of the first tens, the first hour after that, the second hour, the sixth hour, immediately after the second tens, the seventh hour, the eighth hour, the twelfth hour, the eighteenth hour. Method of measurement: Visual analogue scale. Severity of nausea. Timepoint: Before tens, immediately after the intervention of the first tens, the first hour after that, the second hour, the sixth hour, immediately after the second tens, the seventh hour, the eighth hour, the twelfth hour, the eighteenth hou. Method of measurement: Visual analogue scale. Number of Vomiting. Timepoint: Within 18 hours after surgery. Method of measurement: Visual analogue scale. Mashhad University of Medical Sciences Approved 2023-04-11 Ethics in research committee of medicine school of medical university of mashhad Vakil abad Blvd medical university of mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)