Protocol summary
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Study aim
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The effect of melatonin on sleep quality and cognitive function of hemodialysis patients
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Design
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A parallel, randomized controlled clinical trial will be performed on 102 hemodialysis patients referred to the Sari Citizen Dialysis Center. Blocking method is used for randomization.
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Settings and conduct
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The study population in this study will be 102 hemodialysis patients referred to Sari Shahrvand Dialysis Center. Participants in the present study are divided into two groups. 51 placebo participants and the next 51 participants will be given melatonin. The results of both groups will be collected separately and compared at the end.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: People 18 years and older with insomnia problem, hemodialysis for more than 6 month, no hearing and vision problems, the patient can give informed consent
. exclusion criteria: Patients taking anti-anxiety or hypnotic drugs, the patient has an active infection, the patient is pregnant or breastfeeding, the patient has uncontrolled diabetes
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Intervention groups
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Intervention group: Patients in the intervention Group will receive 3 mg of Melatonin at Night, half an hour before bedtime for 6 Weeks. The questionnaire will be completed by the Patient herself or with the help of a Nurse at the beginning of the Study and after 6 weeks in the Group that received Melatonin Control group. At the same time, in the control group, people receive a placebo half an hour before bedtime
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Main outcome variables
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Measuring the sleep quality of patients undergoing hemodialysis, measuring the cognitive functions of patients undergoing hemodialysis
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211030052917N1
Registration date:
2021-12-14, 1400/09/23
Registration timing:
registered_while_recruiting
Last update:
2023-01-25, 1401/11/05
Update count:
1
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Registration date
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2021-12-14, 1400/09/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-11-22, 1400/09/01
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Expected recruitment end date
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2022-02-20, 1400/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Melatonin on Sleep Quality and Cognitive Function of Hemodialysis Patients
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Public title
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The Effect of Melatonin on sleep quality and cognitive function of hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The present study is a randomized, double-blind clinical trial. The randomization method is through blocking. The randomization unit in this study is individual and the randomization tool is done through statistical software. Randomization will be done using Random allocation software. Samples are allocated in 17 blocks of six. That means 6 patients are placed in each block. Three patients are in the intervention group and the other three are in the control group
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The present study is a randomized, double-blind clinical trial. All Dialysis patients participating in this study and the person distributing the drug They do not know which is Placebo to and which ones are Melatonin And only the supervising researcher knows about it. Participants in the present study are divided into two Groups.
51 Participants will be in the Intervention Group and the next 51 will be in the Control Group. After selecting the Samples with inclusion Criteria, the blocking Method will be used for Random Allocation. After creating Random Numbers with the mentioned Software, the Blocking list is provided to the main Executor And the Samples will be entered into the Study accordingly. Patients in the intervention group will receive 3 mg of melatonin at night, half an hour before bedtime for 6 weeks. The packaging of placebo drugs is the same as melatonin in terms of shape, size, color and smell, and the way of receiving placebo will be the same as the intervention group.The results of both groups will be collected separately and compared at the end.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-26, 1400/08/04
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Ethics committee reference number
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IR.MAZUMS.REC.1400.10563
Health conditions studied
1
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Description of health condition studied
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The effect of melatonin on sleep quality and cognitive function in hemodialysis patients
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Patients' sleep quality Score on the Pittsburgh Sleep Quality Assessment Tool
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Timepoint
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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
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Method of measurement
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Pittsburgh Sleep Quality Questionnaire
2
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Description
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Patients' cognitive Function score in the Montreal Cognitive Assessment Tool
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Timepoint
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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
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Method of measurement
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Montreal Cognitive Assessment Questionnaire
Intervention groups
1
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Description
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Intervention group: Patients in the intervention Group will receive 3 mg of Melatonin (Razak Company, 3 mg per tablet) at Night, half an hour before bedtime for 6 Weeks. The questionnaire will be completed by the Patient herself or with the help of a Nurse at the beginning of the Study and after 6 weeks in the Group that received Melatonin. While obtaining the satisfaction of participating in the Study and emphasizing the use of drugs and the absence of side effects And by sending a short message to the Participants or a Member of the patient's family in this research, Patients are reminded about taking medicine.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in the control group will receive a placebo for 6 weeks, half an hour before bedtime. The packaging of placebo drugs is the same as melatonin in terms of shape and size, and the way of receiving Placebo will be the same as the intervention Group. While obtaining the satisfaction of participating in the study and emphasizing the absence of Side effects And By sending a short message to the participants or a member of the patient's family in this study, Patients are reminded about taking Placebo.The placebo will be made by Razak company.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available