The Effect of the Cool Dialysate on the Restless Leg Syndrome in Hemodialysis Patients: Randomized Triple‑Blind Clinical Trial

Restless leg syndrome (RLS) is a common symptom of some diseases specially observed during hemodialysis. Cooling the dialysate is a safe and nonpharmacological method. The aim of this study was to assess the effect of cool dialysate on RLS in hemodialysis patients. A total of 79 patients were selected for screening based on the four main criteria set by the RLS International Association. Finally, in line with the inclusion and exclusion criteria, 63 hemodialysis patients were recruited and participated in this clinical trial. The patients were randomly assigned to the intervention group (n = 32) and the control group (n = 31). The intervention group received 35.5°C dialysate and the control group received 37°C dialysate three times a week for a period of 1 month. The severity of RLS was measured in both groups using a standardized RLS questionnaire. Using R software version 3.3.1, the data were analyzed using the Student’s t‑test, and Wilcoxon test, at 95% confidence interval. In terms of RLS severity, there was no significant difference between intervention and control groups before the intervention (t = ‑2.11, p > 0.05). After the intervention, the mean (SD) of RLS severity in the control group was 28.77 (5.45) and in the intervention group was 11.66 (4.69), in which t test showed a significant difference between two groups (t = 14.03, p = 0.001). Using cool dialysate as a nonpharmacological treatment may reduce the severity of RLS in patients on hemodialysis. Therefore, using this method to improve RLS in hemodialysis patients is recommended.