The effect of melatonin on sleep quality and cognitive function of hemodialysis patients
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Measuring the sleep quality of patients undergoing hemodialysis, measuring the cognitive functions of patients undergoing hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211030052917N1
Registration date:2021-12-14, 1400/09/23
Registration timing:registered_while_recruiting
Last update:2021-12-14, 1400/09/23
Update count:1
Registration date
2021-12-14, 1400/09/23
Registrant information
Name
Marzie Salehi Hikoui
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3323 6086
Email address
m.salehi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Melatonin on Sleep Quality and Cognitive Function of Hemodialysis Patients
Public title
The Effect of Melatonin on sleep quality and cognitive function of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Nasibeh School of Nursing and Midwifery., Mehdiabad St., Shahband St., Amir Mazandarani St., Sari., Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.MAZUMS.REC.1400.538
Health conditions studied
1
Description of health condition studied
The effect of melatonin on sleep quality and cognitive function in hemodialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
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 outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrvand Kidney Patients Center
Full name of responsible person
Dr. Farhad gholami
Street address
Shahrvand Kidney Patients Center, Keshavarz 44, Keshavarz Blvd, sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
339714815
Phone
+98 11 3329 1897
Fax
+98 11 3341 2951
Email
shahrvandtoba۲@gmail.com
Web page address
https://shahrvand.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid saidi
Street address
Mazandaran University of Medical Sciences, at the beginning of Valiasr Highway, Joibar three ways ,Imam Square, Sari
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
publicrel@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marzie Salehi Hikoui
Position
Msc. Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Dokhaniat Street, Etihad Alley, Vahdat Dead End, No. 30
City
Sari
Province
Mazandaran
Postal code
4813955641
Phone
+98 11 3323 6086
Email
marziesalehi12@gmai.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hedayat Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran, Sari, Amir Mazandarani St., Shahband St., Mehdiabad St., Nasibeh School of Nursing and Midwifery
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
hjafari@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marzie Salehi Hikoui
Position
Msc. Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Dokhaniat Street, Etihad Alley, Vahdat Dead End, No. 30
City
Sari
Province
Mazandaran
Postal code
4813955641
Phone
+98 11 3323 6086
Email
marziesalehi12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available