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IRCT20170722035232N1 IRCT 2018-02-10 Sabzevar University of Medical Sciences The Effect of Cool Dialysis on Restless Leg Syndrome The Effects of Cool Dialysate on Restless Leg Syndrome (RLS) in Patients Treated with Hemodialysis 2018-02-14 anticipated 60 Complete https://irct.ir/trial/28454 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be selected using available sampling method and they will take place in intervention and control groups using random allocation permutations blocks, Blinding description: In this study, Patients in both groups will be blinded by a paper cover that is placed on the dialysis temperature display. The researcher will be blinded by completing the questionnaires by researcher assistant. And data analyzers will be blinded by patient encoding. N/A Restless Leg Syndrome. Intervention 1: Intervention group: The hemodialysis fluid temperature (dialysate) will be adjusted to 35.5 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow will not be changed. Intervention 2: Control group: Hemodialysis fluid temperature will be set at 37 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow, and type of device during the study will be fixed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Ehsan Kashani
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 KashaniE94@Medsab.ac.ir Sabzevar University of Medical Sciences scientific Mr. Dr. Mostafa Rad
Pardis of Sabzevar University of Medical Sciences, above the Yadbood of Shohada Gomnam, Boulevard of Tohid
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 mostafarad633@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent to participate in the study Full consciousness and acceptable verbal and auditory ability to answer the questions The patient should not suffer from obvious mental disorder and severe mood - emotional disturbance that prevents effective communication The patient should be in normal neurological and vascular status. Lack of muscular and skeletal disorders debilitating physical activity Lack of ulcer and redness in limbs Patients with chronic renal failure (Patients who have been undergoing hemodialysis for 3 months). Patients who have an arteriovenous fistula, permanent catheter and arterial-venous graft can access their vessels. Patients undergoing hemodialysis three times a week and 4 hours each session. Patients who have had a history of restless leg syndrome during the past 2 months of hemodialysis. Lack of endocrine disorders (such as hypothyroidism and hyperparathyroidism). No history of itchy skin diseases Do not use medicines or foods that they exacerbate the leg syndrome during dialysis, such as: neuroleptics, triangular antidepressants, diphenhydramine, caffeine, alcohol, lithium, beta-blockers, selective serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors. Lack of liver problems No medication or treatments that affect on restless leg syndrome during dialysis(oral medicines, complementary medicine, acupuncture and topical softeners). Patients with KT / V ≥1 Patients with hemoglobin 10-11 mg / dL. Lack of febrile illness and chronic infections (pneumonia, cold during hemodialysis). Use of bicarbonate dialysis solution 18 years 75 years Both Patients with catabolic processes such as: malignancies Diabetic neuropathy Cases of chronic infections, heart failure, chronic pulmonary disease, severe anemia, coronary artery disease and drug abuse G25.81 Restless legs syndrome Treatment - Other Treatment - Other Intervention group: The hemodialysis fluid temperature (dialysate) will be adjusted to 35.5 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow will not be changed. Control group: Hemodialysis fluid temperature will be set at 37 ° C, while the filter type, the ratio of ultrafiltration of the filter, and the speed of the blood flow, and type of device during the study will be fixed. Restless leg syndrome. Timepoint: Before and during and after the intervention. Method of measurement: International Restless Legs Syndrome Study Group Questionnaire. Measuring C-Reactive Protein (CRP). Timepoint: Before the intervention and after the intervention. Method of measurement: Use of CRP kits made by Company QCA Spain. Sabzevar University of Medical Sciences Approved 2016-12-05 Ethics Committee of Sabzevar University of Medical Sciences No. 293, Ibn Yemin No. 41, Ibn Yemin Street Sabzevar Razavi Khorasan Iran (Islamic Republic of)