The effect of oral melatonin on the quality of life, sleep and blood pressure of hemodialysis patients: a randomized clinical trial
Abstract
BACKGROUND: Considering the effect of melatonin on the quality of life and sleep in various diseases such as cancer, in the present study, the effect of melatonin was investigated on the quality of life, sleep, and blood pressure of hemodialysis patient. METHODS: This study was conducted as a double-blind clinical trial. The patients were randomly divided into two groups of 41 people receiving 3 mg of oral melatonin or placebo at night for six weeks. After taking written informed consent, all patients completed demographic, Pittsburgh Sleep Quality Index (PSQI), and Kidney Disease Quality of Life Questionnaire-Short Form (KDQOL-SF) questionnaires. The nurse of dialysis ward measured and recorded systolic and diastolic blood pressure in all patients during dialysis. At the end of the study, the questionnaires were completed again by the patients, and their blood pressure was measured and re-recorded. The data was statistically analyzed using SPSS software 24. RESULTS: Mean age of patients in melatonin and placebo group was 48.97 ± 9.77 and 50.07 ± 12.65, respectively (p = 0.661). There was no statistically difference between two groups regarding gender distribution (p = 0.64) and Body mass index (p = 0.15), duration of hemodialysis (p = 0.54), systolic blood pressure (p = 0.7), diastolic blood pressure (p = 0.13), PSQI score (p = 0.73) and KDQOL-SF score in all domains (p > 0.05) before intervention. After intervention, there was no significant difference between two groups…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 41 participants or records.
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