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IRCT20220504054738N1 IRCT 2023-03-08 Kashan University of Medical Sciences The effect of melatonin on sleep quality in patients with mild traumatic brain injury The effect of melatonin on sleep quality in patients with mild traumatic brain injury 2023-03-21 anticipated 60 Complete https://irct.ir/trial/63692 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method with blocks of equal and constant size (there will be 6 blocks, in each block two people from the intervention group, two people from the control group, two people from the routine treatment group) In order to create balance and comply with the condition of randomization in sampling and allocating the sample to each of the studied groups, it will be used. It is worth mentioning that the sample will be entered in each of the pre-designed blocks according to the time of entering the study, Blinding description: For blinding, drugs (melatonin, clonazepam, and placebo) will be packaged in separate but similar packages and labeled A, B, and C. Medications will be received and labeled by a third party. As a result, the prescriber (researcher) and the patient will be unaware of the type of drug in each package and will not know what drugs are in the three packages. 3 mild traumatic brain injury. Intervention 1: Intervention group: 3 mg melatonin tablet from Razek Pharmaceutical Company is prescribed at night (one hour before bedtime).If there is no proper response in the melatonin group, the amount of drug will increase to 6 mg, provided there are no side effects. The duration of treatment for the intervention group will be 4 weeks. Intervention 2: Intervention group: 1 mg clonazepam tablet from Sobhan Daru Pharmaceutical Company is prescribed overnight (one hour before bedtime). If there is no proper response in the clonazepam group, it will be increased to 2 mg provided there are no side effects. The duration of treatment for this group will be 4 weeks. Intervention 3: Control group: For the placebo group, one placebo is prescribed overnight (one hour before bedtime). Yes - There is a plan to make this available What will be shared: The effect of melatonin on sleep quality in patients with mild traumatic brain injury When: till ten year after gathering of datum To whom: people who are introduced by research institutes, universities and prestigious scientific centers or from ethics committees. Conditions: To conduct meta-analysis studies in the field of study Where to obtain: Vice President of Technology and Research of Kashan School of Medical Sciences How to obtain: Sending a letter to the Deputy of Technology and Research of Kashan University of Medical Sciences. Examination of the letter in the research and ethics committee of this vice president, approval of the request by this committee. Send the data file to the requesting person. Comments:
public Aidin Omidvar
Qutb-e-Ravandi Boulevard
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5500 9999 mahshad.m125@gmail.com Kashan University of Medical Sciences scientific Aidin Omidvar
Qutb-e-Ravandi Boulevard
Kashan Iran (Islamic Republic of) 8715973474 0983155009999 aydineomidvar84@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Not having a proved sleep disorder History of mTBI during one past month Not having allergy to both if the drugs Not having hepatic failure Not having respiratory problems or apnea and not consuming opiates Not having cognitive disorders or dimentia Age between 18 to 60 18 years 60 years Both Cessation of therapy Consuming other hypnotic drugs otherwise the ones ordered in this study Manifestation of adverse drug reaction during the study S06.0X Concussion Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 3 mg melatonin tablet from Razek Pharmaceutical Company is prescribed at night (one hour before bedtime).If there is no proper response in the melatonin group, the amount of drug will increase to 6 mg, provided there are no side effects. The duration of treatment for the intervention group will be 4 weeks. Intervention group: 1 mg clonazepam tablet from Sobhan Daru Pharmaceutical Company is prescribed overnight (one hour before bedtime). If there is no proper response in the clonazepam group, it will be increased to 2 mg provided there are no side effects. The duration of treatment for this group will be 4 weeks. Control group: For the placebo group, one placebo is prescribed overnight (one hour before bedtime) Sleep quality. Timepoint: Measurements will be taken at the beginning of the study, after the end of treatment, one month and three months after treatment (4 times). Method of measurement: The instruments used to examine patients will be a researcher-made demographic questionnaire and the Petersburg Sleep Quality index Questionnaire and Epworth Questionnaire. Kashan University of Medical Sciences Approved 2023-01-08 Ethics committee in medical and dental school researches Kashan.Qutb Ravandi Blvd.hekmat56. کاشان Isfehan Iran (Islamic Republic of)