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IRCT20230205057333N1 IRCT 2023-03-15 Yasouj University of Medical Sciences The effect of oral melatonin on the quality of life, sleep and blood pressure of renal failure patients Assessment of the effect of oral melatonin on the quality of life and sleep and blood pressure of kidney failure patients in the hemodialysis departments of Yasouj city: a randomized clinical trial. 2023-02-20 anticipated 82 Complete https://irct.ir/trial/68620 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study is a simple randomization type. Patients are examined individually for randomization. For randomization, each person is assigned a number from 1 to 82. Then, by reading the table of random numbers from left to right, odd numbers are considered for the intervention group and even numbers are considered for the placebo group. From patient number 1 to 82, according to the number of random numbers table (even or odd), they are entered into the intervention or placebo group. This means that when reading the table of random numbers, the first number will be for patient number 1, the second number will be for patient number 2, and so on, based on whether the number in the table of random numbers is odd or even, the patients are divided into the above-mentioned two groups, Blinding description: In this study, the patient and the clinical caregiver are unaware of the group (intervention/placebo), and the groups are named groups A and B. The researcher and supervisor are aware of the intervention and placebo groups. 3 Chronic kidney disease. Intervention 1: Intervention group: Taking 3 mg of oral melatonin at night / Hakim Pharmaceutical Company, for six weeks. Intervention 2: Control group: Taking starch tablets at night for six week. 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 There is no further information
public َArash Iranmanesh
Emam sajjad hospital
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3322 0166 rozina.abasi@yums.ac.ir Yasouj University of Medical Sciences scientific َArash Iranmanesh
Emam sajjad hospital
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3322 0166 rozina.abasi@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Ability to give informed consent The duration of hemodialysis is at least 3 months 18 years no limit Both Peritoneal Dialysis Known major disease (malignancy, uncontrolled infection, uncontrolled heart failure) pregnancy Acute medical or surgical illness that requires hospitalization or surgery severe psychological illness (severe depression, psychosis, dementia) History of sensitivity to melatonin N18 Chronic kidney disease (CKD) Treatment - Drugs Placebo Intervention group: Taking 3 mg of oral melatonin at night / Hakim Pharmaceutical Company, for six weeks Control group: Taking starch tablets at night for six week Sleep quality. Timepoint: At the beginning of the study and at the end of the sixth week. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). Quality of Life. Timepoint: At the beginning of the study and at the end of the sixth week. Method of measurement: Quality of Life Questionnaire of Kidney Patients (KDQOL - SF™ 1/3). Blood pressure. Timepoint: At the beginning of study, at the end of the third and sixth week. Method of measurement: In all patients, systolic and diastolic blood pressure during dialysis will be measured and recorded using erka sphygmomanometer. Yasouj University of Medical Sciences Approved 2023-01-30 Ethics Committee of Yasouj University of Medical Sciences Shahid Motahari St., Vice President of Research, Yasouj University of Medical Sciences Yasouj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)