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Study aim
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The effect of melatonin on sleep disorders in children with any type of cerebral palsy
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Design
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Clinical trial with a control group, with parallel groups, triple blind, randomized, phase 2 on 50 patients. Random blocks with sealed envelopes were used for randomization
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Settings and conduct
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Children 2 to 12 years old with cerebral palsy who complained of sleep disorders were selected by the convenient sampling method. The study sample size was 50 children. in the intervention group, patients 30 minutes before sleeping received 3 mg melatonin and the control group received placebo (3 mg lactose). The duration of treatment was one month. In both groups in the first two nights, the quality (The time required to fall asleep and the duration of sleep) and depth of sleep without medication was measured. After the second night onwards, both groups received medication and then the quality and depth of sleep at the end of the month in both groups were compared with the first two nights.
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Participants/Inclusion and exclusion criteria
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Children (boys and girls) 2 to 12 years old with cerebral palsy of any kind who complained of sleep disorders referred to the pediatric neurology clinic of Ghaem Educational, Research and Treatment Center in the holy city of Mashhad.
Outcome criteria of this study include non-cooperation of the patient or their parents from participating in the project and the existence of side effects of melatonin during treatment
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Intervention groups
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In the intervention group, patients received 3 mg oral melatonin tablets 30 minutes before going to bed, and in the control group, patients received a placebo (3 mg oral lactose) 30 minutes before going to bed with the same color, smell, taste, and shape.
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Main outcome variables
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the quality of sleep (time to fall asleep, duration of sleep, depth of sleep)