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IRCT20230521058244N1 IRCT 2023-09-13 Bagheiat-allah University of Medical Sciences The effect of cold dialysis solution in hemodialysis patients The effect of using cold dialysis solution on Subjective Hemodialysis Adequacy, sleep quality and Physiological variables during hemodialysis in patients with End-Stage Renal Disease (ESRD) 2023-08-11 anticipated 80 Complete https://irct.ir/trial/70286 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the present research, the samples will be first selected using the convenience sampling method from hemodialysis patients (confirmed by a nephrologist) meeting the inclusion criteria; then, they will be randomly assigned to two intervention and control groups in such a way that some envelopes containing cards labeled M and C will be prepared and the participants will be asked to randomly choose one of the envelopes. The individuals who take the M card will be assigned to the intervention group, and those who take the C card will be assigned to the control group. Thus, the sampling will continue until reaching the determined sample size, Blinding description: The current research will be a single-blind study. The blinded group will be the patients participating in the study. The blinding will be performed in this way: The patients will receive the type of hemodialysis considered for them (both groups of patients receiving cold hemodialysis and conventional hemodialysis) in sealed coded envelopes without having any information about the type of hemodialysis, and considering the gradual decrease in the temperature of hemodialysis, the experimental group patients will not notice the temperature change. N/A patients with End-Stage Renal Disease (ESRD). Intervention 1: Intervention group: Receive cold hemodialysis . The device temperature will be kept at 35℃ for 4 weeks. Intervention 2: Control group: Patients receiving normal hemodialysis with a temperature of 37. 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 It is done according to the opinion of the university and the supervisor
public alihosseinzadeh
MollaSadra street , Vanak Square , Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 hosseinzadeh.ah@gmail.com Bagheiat-allah University of Medical Sciences scientific Abolfazl Rahimi
MollaSadra street , Vanak Square , Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 fazel123@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Performing hemodialysis at least twice a week Over 18 years of age Full consciousness and ability to hear and speak to answer questions Hemoglobin level > 8 mg/dL 18 years no limit Both Presence of concurrent malignancy Endocrine disorders (hypothyroidism and hyperparathyroidism) Patients with acute mental and physical problems (such as divorce, death of a loved one, financial problems, and developing new chronic disease) Getting an active infection in the body (such as a cold and other infectious diseases) N18.6 End stage renal disease Treatment - Devices Treatment - Devices Intervention group: Receive cold hemodialysis . The device temperature will be kept at 35℃ for 4 weeks. Control group: Patients receiving normal hemodialysis with a temperature of 37 Subjective Hemodialysis Adequacy score of patients with with End-Stage Renal Disease in Subjective Hemodialysis Adequacy Questionnaire designed and psychometrically evaluated by Bi Niaz et al. Timepoint: before intervention and at the end of the intervention. Method of measurement: Subjective Hemodialysis Adequacy Questionnaire designed and psychometrically evaluated by Bi Niaz et al. Richard Campbell sleep quality score of patients with with End-Stage Renal Disease. Timepoint: before intervention and at the end of the intervention. Method of measurement: "Richard Campbell sleep quality questionnaire". Bagheiat-allah University of Medical Sciences Approved 2023-07-24 Research Ethics Committees of Baqiyatallah Hospital MollaSadra street , Vanak Square , Tehran Tehran Tehran Iran (Islamic Republic of)