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IRCT20200124046235N1 IRCT 2020-04-01 Sabzevar University of Medical Sciences The effects of cool dialysate on sexual dysfunction in hemodialysis patients The effects of cool dialysate on sexual dysfunction in hemodialysis patients in mashhad hemodialysis centers 2020-02-09 anticipated 60 Complete https://irct.ir/trial/45309 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First samples will be selected by convenience method according to inclusion and exclusion criteria. Then random assignment will be used with permuted blocking. R Software will be used to get the blocks. The blocks are made up of 4 English letters (A,B,C,D). A ,B will be considered for the intervention group, and other three letters (C, D) 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 DACB block means from left hand, first and third, respectively, will be located in the control group, and the second and fourth of participants will be located in the intervention group, respectively, 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 Sexual disorders. 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 hemodialysis fluid (dialysate) is set at 37 ° 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 control group will undergo dialysis with cold solution of 37 ° C for 3 times each week for 4 hours each time. Yes - There is a plan to make this available What will be shared: Participants' personal data will not be shared. When: Participants' personal data will not be shared. To whom: if the data is required it will be made available to scientific and academic institutions , with due regard for the confidentiality of information. Conditions: The results of the study will be communicated to the patients themselves. Where to obtain: if necessary, corresponding author of the manuscript will provide the data to scientific institutions How to obtain: Editor of the journal can be applied the data and corresponding author should delivered data to them via email within a month Comments:
public Rahele Hasanpour Moghaddam
No61, Moasavi Gochni17, Mosavi Ghochani street
Mashhad Iran (Islamic Republic of) 9188655715 +98 51 3711 2578 hasanpourmr2@mums.ac.ir Sabzevar University of Medical Sciences scientific Rahele Hasanpour Moghaddam
No. 61, Mosavi Ghochni17, Mosavi Ghochani Street
Mashhad Iran (Islamic Republic of) 9188655715 +98 51 3711 2578 hasanpourmr2@mums.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being married Having a sexual partner performing hemodialysis twice and more a week 20 years 75 years Both taking sex drugs Surgery on the genital area due to sexual disorders Hyperparathyroidism Bisexuality َHemoglobin below 9 mg/dl major depression Rehabilitation Rehabilitation 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 hemodialysis fluid (dialysate) is set at 37 ° 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 control group will undergo dialysis with cold solution of 37 ° C for 3 times each week for 4 hours each time. Sexual function score of female patients ُ. Timepoint: Before intervention and one month after the intervention. Method of measurement: Female Sexual Function Index. Sexual function score of male patients. Timepoint: Before intervention and one month after the intervention. Method of measurement: International Index of Erectile Function. Sabzevar University of Medical Sciences Approved 2020-01-14 National Committee for Ethics in Biomedical Research Pardis of University of Medical Sciences, Nuclear Martyrs Boulevard, Sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)