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IRCT20200215046495N1 IRCT 2020-03-02 Sabzevar University of Medical Sciences The Effect of Cool Dialysate on Depression The Effect of Cool Dialysate on Depression in Hemodialysis Patients 2020-04-20 anticipated 66 Complete https://irct.ir/trial/45825 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be selected by available sampling and will be randomly assigned to intervention and control groups using random allocation blocks.R Software will be used to get the blocks. The blocks are made up of 6 English letters (A,B,C,D,E,F). A ,B,C will be considered for the intervention group, and other three letters (D,E,F) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DCAFBE block means from left hand, first, fourth and sixth, respectively, will be located in the control group, and the second, third, and fifth of participants will be located in the intervention group, respectively. Thus, eleven blocks will be selected to complete the sampling, Blinding description: In this study, patients in both intervention and control groups will be blinded using a paper cover made by the researcher assistance with the specified dimensions and placed on the dialysis machine's temperature monitor, The researcher will be blinded by the researcher assistance by handing out the questionnaires and the data analyzer will be blinded by the coding of the patients. N/A Chronic kidney disease, Under Hemodialysis. Intervention 1: Intervention group: The temperature of hemodialysis fluid (dialysate) is set at 35.5 ° C while the type of filter, filter ultrafiltration coefficient, and blood flow rate will not change.All patients will undergo hemodialysis with Fresenius B-4008. The filters used for hemodialysis during the study will be fixed for each patient. The hemodialysis flow rate solution in all patients will be 500 ml / min. The temperature of the hemodialysis unit will be maintained at 22 ° C throughout the study. The vital signs of the patients, especially the body temperature, will be monitored every hour. Patients in the intervention group will undergo dialysis with cold solution of 35.5 ° C for 3 times each week for 4 hours each time. Intervention 2: Control group: The temperature of the hemodialysis fluid is set at 37 ° C. While the type of filter, filter ultrafiltration, blood flow rate, and device type will be constant throughout the study. All conditions in the intervention group will be adjusted for the control group except dialysis temperature which will be set at 37° C. Yes - There is a plan to make this available What will be shared: Information on the main outcome (severity of depression) will be shared. When: Nine months after the results were published To whom: Data will be available only to researchers working in academic and scientific institutions. Conditions: Don't use submitted data to print articles. Where to obtain: Dr. Rad Mostafa , Email: mostafarad633@yahoo.com Phone No: 0098 51 44018300 How to obtain: Upon request by the supervisor, Dr. Rad Mostafa will be provided with documentation and files at the Secretariat. Comments:
public Farhadi Maryam
University of Medical Sciences Pardis, Above Unknown Martyrs, Nuclear Martyrs Boulevard
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 Farhadim356@gmail.com Sabzevar University of Medical Sciences scientific Dr. Rad Mustafa
University of Medical Sciences Pardis, Above Unknown Martyrs, Nuclear Martyrs Boulevard
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) Having informed consent to participate in the study Ages over 18 years of any gender Patient with a diagnosis of chronic renal failure (patients who have been hemodialysis for 6 months) Under hemodialysis 3 times a week and each session 4 hours Have complete alertness and acceptable verbal and hearing ability to answer questions Patients with KT/V greater than or equal to 1 18 years no limit Both Treated with antidepressants Malignancy Known hypothyroidism Patients with hemoglobin less than 8 mg/dL Patients whose access to the vessels is through a temporary catheter or Shaldon N18.5 Chronic kidney disease, stage 5 Treatment - Other Treatment - Other Intervention group: The temperature of hemodialysis fluid (dialysate) is set at 35.5 ° C while the type of filter, filter ultrafiltration coefficient, and blood flow rate will not change.All patients will undergo hemodialysis with Fresenius B-4008. The filters used for hemodialysis during the study will be fixed for each patient. The hemodialysis flow rate solution in all patients will be 500 ml / min. The temperature of the hemodialysis unit will be maintained at 22 ° C throughout the study. The vital signs of the patients, especially the body temperature, will be monitored every hour. Patients in the intervention group will undergo dialysis with cold solution of 35.5 ° C for 3 times each week for 4 hours each time. Control group: The temperature of the hemodialysis fluid is set at 37 ° C. While the type of filter, filter ultrafiltration, blood flow rate, and device type will be constant throughout the study. All conditions in the intervention group will be adjusted for the control group except dialysis temperature which will be set at 37° C. Depression score on Beck Questionnaire 2. Timepoint: Measurement of depression score before and after the last intervention session (end of the 12th hemodialysis session) and two weeks after the intervention. Method of measurement: Beck Depression Inventory II (BDI-II). Sabzevar University of Medical Sciences Approved 2020-02-22 Ethics committee of Sabzevar University of Medical Sciences Block B, University of Medical Sciences Pardis, Above Unknown Martyrs, Nuclear Martyrs Boulevard Sabzevar Razavi Khorasan Iran (Islamic Republic of)