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IRCT20211030052917N1 IRCT 2021-12-14 Mazandaran University of Medical Sciences The Effect of Melatonin on sleep quality and cognitive function of hemodialysis patients The Effect of Melatonin on Sleep Quality and Cognitive Function of Hemodialysis Patients 2021-11-22 anticipated 102 Complete https://irct.ir/trial/59703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 The effect of melatonin on sleep quality and cognitive function in hemodialysis patients. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Marzie Salehi Hikoui
Dokhaniat Street, Etihad Alley, Vahdat Dead End, No. 30
Sari Iran (Islamic Republic of) 4813955641 +98 11 3323 6086 marziesalehi12@gmai.com Mazandaran University of Medical Sciences scientific Dr. Hedayat Jafari
Mazandaran, Sari, Amir Mazandarani St., Shahband St., Mehdiabad St., Nasibeh School of Nursing and Midwifery
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7342 hjafari@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 Treatment - Drugs Placebo 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. 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. 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. Mazandaran University of Medical Sciences Approved 2021-10-26 Ethic committee of Mazandaran University of Medical Sciences Mazandaran, Sari, Amir Mazandarani St., Shahband St., Mehdiabad St., Nasibeh School of Nursing and Midwifery Sari Mazandaran Iran (Islamic Republic of)