Goldouzi Hamid Reza, Akhondian Javad, Beiraghi Toosi Mehran, Mehrad Majd Hassan, Shekari Shima, Babaei Meisam
Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Clinical Research Development Center, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Child Neurol. 2024 Winter;18(1):51-59. doi: 10.22037/ijcn.v18i1.41949. Epub 2024 Jan 18.
Cerebral palsy (CP) is one of the most common causes of serious physical disability in childhood and is a persistent movement disorder before the age of three. This disorder can negatively affect both the child and their family. In recent years, the use of melatonin as a safe, effective, and cheap drug has been expanding in improving the sleep disorders of these children. Therefore, this study aimed to investigate melatonin's effect on sleep disorders in children with CP.
MATERIALS & METHODS: This double-blind clinical trial was conducted on children aged 2 to 12 years with CP who were referred to the pediatric neurology clinic for sleep problems. The participants were included in the study by convenience sampling. After obtaining informed consent from parents, patients were divided randomly into two intervention (melatonin) and control (placebo) groups. In the intervention group, patients received oral melatonin tablets, and in the control group, patients received a placebo (3 mg oral lactose) 30 minutes before going to sleep.
The results of this study showed no significant relationship between age and gender with sleep disorders in children with CP (P>0.05). A significant effect of melatonin on sleep disorders was found in children with CP. The greatest effect of melatonin is the time required to start falling asleep. Melatonin was associated with decreased time needed to fall asleep and increased sleep duration.
The results of the study demonstrated that sleep disorders are prevalent among children with CP. Therefore, proper and timely treatment of these children is crucial. According to the present study's findings, melatonin effectively improves the time of falling asleep and these children's sleep duration.
脑瘫（CP）是儿童严重身体残疾的最常见原因之一，是三岁前持续存在的运动障碍。这种疾病会对儿童及其家庭产生负面影响。近年来，褪黑素作为一种安全、有效且廉价的药物，在改善这些儿童的睡眠障碍方面的应用不断扩大。因此，本研究旨在调查褪黑素对脑瘫患儿睡眠障碍的影响。
本双盲临床试验针对年龄在2至12岁、因睡眠问题转诊至儿科神经科门诊的脑瘫患儿进行。通过便利抽样将参与者纳入研究。在获得家长的知情同意后，将患者随机分为两个干预组（褪黑素组）和对照组（安慰剂组）。干预组患者睡前30分钟口服褪黑素片，对照组患者睡前30分钟口服安慰剂（3毫克口服乳糖）。
本研究结果显示，脑瘫患儿的年龄和性别与睡眠障碍之间无显著相关性（P>0.05）。发现褪黑素对脑瘫患儿的睡眠障碍有显著影响。褪黑素的最大作用是入睡所需时间。褪黑素与入睡所需时间减少和睡眠时间延长有关。
研究结果表明，睡眠障碍在脑瘫患儿中普遍存在。因此，对这些儿童进行适当及时的治疗至关重要。根据本研究结果，褪黑素能有效改善入睡时间和这些儿童的睡眠时间。
