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IRCT20220601055047N1 IRCT 2022-09-03 Sabzevar University of Medical Sciences The effect ofTranscutaneous electrical nerve stimulation onrestless legs syndrome The effect ofTranscutaneous electrical nerve stimulation on the severity of restless legs syndrome in hemodialysis patients referred to the dialysis ward of Sabzevar Vasei Hospital and Imam Khomeini Hospital in Esfarayen 2022-07-23 anticipated 60 Complete https://irct.ir/trial/63925 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sequence of random allocation and the list of blocks, by the statistical consultant and to Software help will be available. website https://www.sealedenvelope.com is a useful site for production The random sequence for randomization is block type. This site It is designed in such a way that there is a limit in the number of groups There is no random assignment. From block method to volume 4 to create A random allocation sequence is used. According to the total number of samples The requirement for the study is 60 patients. 30 patients in the intervention group A and 30 patients are in group B. There are 15 quadruple blocks including two Group A and B are randomly designed through the software, for example Continue on...... (ABAB), (BBAB), (AABB), (ABBA), (BAAB) Based on the sample size, 60 envelopes 30 envelopes including paper containing A and 30). An envelope containing B is prepared.Based on the list of blocks A randomly prepared quadruple, a trained person outside the research team, He is responsible for randomly assigning patients, after the arrival of each Patient and hospitalized in the special ward, according to 15 blocks of four prepared in The first stage of each patient randomly in intervention group A and group B The samples will be placed and the sample process will be done sequentially Sampling will be done, the code of each patient to his family member as well Will allocate data. People in the order of their entry into the study and form Randomly assigned to the desired group through randomized blocks Finds. For example, according to the ABAB block, each patient after entering the study, entered into the intervention, sham, intervention and sham groups, respectively will be This process continues until the last block is selected, Blinding description: In this study, patients in each intervention and control group (sham) will be considered as a separate room for not exchanging information with patients referred for interview and training, and patients will be reminded not to exchange information with other patients during the study. N/A Severity of restless leg syndrome in hemodialysis patients. Intervention 1: Intervention group: In this study, after confirming restless leg syndrome, TENS electric current with a frequency of 100 Hz will be performed for the patients of the test group for 3 times and for 20 minutes in each stage. Intervention 2: Control group: In this study, after confirming restless legs syndrome, TENS electric current with a frequency of 20 Hz will be performed for the patients of the test group for 3 times and for 20 minutes in each stage. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome or the like, will be shared. When: The access period begins 4 months after the results are published. To whom: Researchers working in academic institutions and hospitals Conditions: 1- For the use of other patients who have this restless legs syndrome, except hemodialysis patients 2- To provide new research work with more patients and new variables Where to obtain: Sabzevar Faculty of Medical Sciences - University Central Library Contact number: 05144018300 Esfrain Faculty of Medical Sciences - Imam Khomeini Hospital (RA) - Abolfazl Kalmishi09232709619 : contact number How to obtain: Go to the library of Sabzevar University of Medical Sciences and refer to the librarian and receive the electronic pdf of the thesis Also, contact the author of the thesis and send the thesis to the target person Comments:
public Abolfazal Kalmishi
Esfrain, Nawab St., Shahid Moradi Alley
Esfrain Iran (Islamic Republic of) 9661665596 +98 58 3722 6852 a.kalmish2020@gmail.com Sabzevar University of Medical Sciences scientific Abolfazal kalmishi
Esfrain, Nawab St., Shahid Moradi Alley
Esfrain Iran (Islamic Republic of) 9661665596 +98 58 3722 6852 a.kalmish2020@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Hemodialysis patients aged 18-75 years and older suffering from restless leg syndrome based on the self-report of the hemodialysis patient no history of neurological and mental illness except restless leg syndrome Absence of vascular diseases except restless leg syndrome absence of neuromuscular disorders, absence of crisis experience during the last 3 months 18 years 75 years Both The patient's unwillingness to cooperate Antispasmodic use in the past two weeks Anticonvulsant use within the past two weeks Use of sedatives in the past two weeks Use of antidepressants in the past two weeks Use of herbal medicines during the last two weeks N18.5 Chronic kidney disease, stage 5 Treatment - Other Placebo Intervention group: In this study, after confirming restless leg syndrome, TENS electric current with a frequency of 100 Hz will be performed for the patients of the test group for 3 times and for 20 minutes in each stage. Control group: In this study, after confirming restless legs syndrome, TENS electric current with a frequency of 20 Hz will be performed for the patients of the test group for 3 times and for 20 minutes in each stage. Severity of restless legs syndrome. Timepoint: 3 shifts of 20 minutes. Method of measurement: Restless Leg Syndrome International Questionnaire. Sabzevar University of Medical Sciences Approved 2022-07-13 Research Ethics Committee of Sabzevar University of Medical Sciences Sabzevar, Tawheed Shahr Blvd., above the Martyrs' Tomb, University Campus Building, Educational Assistant Sabzevar Razavi Khorasan Iran (Islamic Republic of)