The Effect of Melatonin on sleep quality and cognitive function of hemodialysis patients

Phase 3

Conditions: The effect of melatonin on sleep quality and cognitive function in hemodialysis patients.

Registration Number: IRCT20211030052917N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 102

Inclusion Criteria

People 18 years and older
The patient should not involved in any other research project
The patient can give informed consent
Hemodialysis for more than 6 months
The patient has a Pittsburgh sleep quality index score higher than 5
The patient has a Montreal cognitive function index score lower than 26
The patient has adequate vision and hearing
The patient has normal thyroid tests

Exclusion Criteria

The patient has already taken melatonin
The patient has a history of taking sleeping pills
The patient has a history of taking any drugs
The patient has an active infection
The patient is pregnant or breastfeeding
The patient has uncontrolled diabetes
The patient has dementia
The patient has liver disorders
The patient has cerebrovascular disorders
The patient needs immediately Intervention for Hospitalization and surgery
The patient has heart failure
The patient has iron deficiency anemia
Patients taking anti-anxiety or hypnotic drugs due to neuropsychiatric disorders

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' sleep quality Score on the Pittsburgh Sleep Quality Assessment Tool. Timepoint: Measurement of Sleep Quality at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Pittsburgh Sleep Quality Questionnaire.;Patients' cognitive Function score in the Montreal Cognitive Assessment Tool. Timepoint: Measurement of cognitive Functions at the beginning of the Study (before the intervention) and immediately after the intervention in the intervention Group and Control Group. Method of measurement: Montreal Cognitive Assessment Questionnaire.

Secondary Outcome Measures