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IRCT20191017045142N1 IRCT 2021-07-07 Mashhad University of Medical Sciences The effect of melatonin on sleep disorders in children with cerebral palsy The study of effectiveness of melatonin on sleep disorders in children with cerebral palsy (CP) 2018-07-23 anticipated 50 Complete https://irct.ir/trial/43126 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization using "random allocation" software will be conducted. In this type of randomization, blocking is usually used to create a balance in the number of samples assigned to each of the studied groups. This study has 5 blocks of 10. Half of each block belongs to the patients of the control group and the other half belongs to the intervention group. Random sequences created by the software are written on cards and placed in sealed envelopes, respectively, Blinding description: In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the the grouping. Patients in the control group receive placebo drug. 3 Condition 1: cerebral palsy. Condition 2: Sleep disorders. Intervention 1: Intervention group: Patients receive 3 mg oral melatonin tablets produced by (Razak company) 30 minutes before going to sleep. Next, the patient wears a smart watch which, based on the frequency of hand movement, records the time of falling asleep, light and deep sleep and waking up time. Intervention 2: Control group: Patients receive a placebo (3 mg oral lactose) 30 minutes before bedtime with the same color, smell, taste and shape as the medication in the intervention group. Next, the patient wears a smart watch which, based on the frequency of hand movement, records the time of falling asleep, light and deep sleep and waking up time. 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 Hamid Reza Goldouzi
Kohsangi 28 NO 7
Mashhad Iran (Islamic Republic of) 9175934477 +98 51 3846 2224 hamid.reza.goldozian@gmail.com Mashhad University of Medical Sciences scientific Hamid Reza Goldouzi
Kohsangi 28 NO 7
Mashhad Iran (Islamic Republic of) 9175934477 +98 51 3846 2224 hamid.reza.goldozian@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Children with cerebral palsy with sleep disorders 2 years 12 years Both Change in medication which can affect sleep in the past month such as anticonvulsants and sedatives G80.0 G47 Spastic quadriplegic cerebral palsy Sleep disorders Treatment - Drugs Placebo Intervention group: Patients receive 3 mg oral melatonin tablets produced by (Razak company) 30 minutes before going to sleep. Next, the patient wears a smart watch which, based on the frequency of hand movement, records the time of falling asleep, light and deep sleep and waking up time. Control group: Patients receive a placebo (3 mg oral lactose) 30 minutes before bedtime with the same color, smell, taste and shape as the medication in the intervention group. Next, the patient wears a smart watch which, based on the frequency of hand movement, records the time of falling asleep, light and deep sleep and waking up time. Time required to start sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medicationwith the first two nights (without medication). Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement. Duration of sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement. Duration of deep sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement. Duration of light sleep. Timepoint: In both groups, two nights before beginning the study and receiving medication and also at the end of the month after receiving the medication. Method of measurement: Using the actigraphy method with Xiaomi (China) smart watches which work based on the frequency of hand movement. Mashhad University of Medical Sciences Approved 2020-01-08 Organizational Ethics Committee of Mashhad University of Medical Sciences Daneshgah street, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)