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.

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.

A placebo-controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 82 patients. A simple randomization method using a table of random numbers will be used.

This study will be conducted in the hemodialysis center of Yasouj city. After obtaining informed consent, the patients will be randomly divided into two groups of 41 people receiving 3 mg of melatonin or placebo at night. The duration of the study will be 6 weeks. Grouping of patients will be based on A and B codes, and the patient or therapist will not know about the grouping of patients.

Inclusion criteria include age over 18 years, the ability to give informed consent, and the duration of hemodialysis of at least three months. Exclusion criteria include peritoneal dialysis, known major illness (malignancy, uncontrolled infection, uncontrolled heart failure), pregnancy, acute medical or surgical illness requiring hospitalization or surgery, severe psychological illness (severe depression, psychosis, dementia), and a history of sensitivity to melatonin.

In the intervention group, patients receive 3 mg of melatonin orally at night. In the placebo group, patients receive a starch tablet at night.

Quality of sleep; quality of life; blood pressure during dialysis

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.

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.