Study of the effects of short-term melatonin on salivary cortisol and sleep quality of hemodialysis patients

Determination of Short-term Effects of Melatonin on Salivary Cortisol Level and Sleep Quality in Hemodialysis Patients

Clinical trial with control group, with parallel groups, double blind, randomized, with statistical software, with a sample size of 40 participants

This study is performed on patients with severe renal failure who are referred to Hemodialysis Center of Gorgan 5 Azar Hospital for dialysis. Of the eligible individuals with a score of 5 or more in the Pittsburgh Questionnaire, 40 patients are selected after numbering from 1 to 40. Saliva samples are taken from patients for measuring cortisol salivary at 11 o'clock before dialysis and at 8 o'clock in the morning before starting dialysis. Then, according to the data given by the software program, patients are in the two groups receiving the drug or placebo. Neither the research subjects nor the investigator have any information on the acceptability of each drug or placebo group. One group received 3 mg melatonin and another one received placebo for 2 weeks. At the end of 2 weeks, sampling is done to determine the salivary concentrations of cortisol. The Pittsburgh questionnaire is also filled up by participants for the purpose of assessing the quality of sleep

Inclusion Criteria : ESRD patients who have undergone hemodialysis for more than 3 months , Under-75 years old, More than 5 scores in the Pittsburgh questionnaire; Exclusion criteria : Seriuos and severe illness (malignancy, congestive heart failure and Active infection), pregnancy, iron deficiency anemia, uncontrolled diabetes mellitus (HbA1c> 7.5), severe depression, psychotic disorders, continuous use of medications that affect sleep, corticosteroid use

In this study, one group received melatonin and another received placebo

Determination of short-term effects of melatonin on salivary cortisol level and overall sleep score in dialysis patients; Determine the relationship between cortisol salivary levels and overall sleep score before and after intervention

Individuals are randomly assigned to one study group with statistical software and receive intervention from the same group

Neither the research subjects nor the investigator have any information on the acceptability of each drug or placebo group