Music-Based Intervention for Pediatric Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Sleep Efficiency
研究概览
简要总结
The goal of this clinical trial is to learn if a music-based intervention works to improve sleep and health in children with epilepsy and their parents. The main question it aims to answer is: Does the music-based intervention improve sleep and health for both the children and their parents?
详细描述
Researchers will compare two different music modules, an experimental module and a control module, to determine if the experimental module yields better outcomes.
Participants will:
- Listen to one of the two assigned music modules twice a day (once before bedtime and once after waking up) for 6 months.
- Complete 4 assessments, include wearing an activity and sleep tracking device, keeping a daily sleep diary, and filling out questionnaires.
- Maintain a diary to record any seizure activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 1.5 and 9 years with epilepsy;
- •Parents with sufficient Chinese language proficiency and skills to comprehend the study procedures and complete questionnaires.
排除标准
- •Children who have severe hearing loss even with the use of hearing devices;
- •Children who are bedridden;
- •Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders;
- •Children with severe motor dysfunction that preclude differentiation of sleep and wake states via actigraphy.
研究组 & 干预措施
Experimental music intervention group
Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months.
干预措施: Music-based intervention (Behavioral)
Active control music group
Participants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months.
干预措施: Active Control Placebo (Behavioral)
结局指标
主要结局
Sleep Efficiency
时间窗: Baseline, 2 weeks, 3 months, and 6 months after randomization
Sleep efficiency, measured objectively using actigraphy, is a key indicator of sleep quality. It is calculated as the ratio of total nighttime sleep time to time in bed, multiplied by 100%.
次要结局
- Child Behavior Checklist (CBCL)(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Daily 24-hour Sleep Duration(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Sleep Onset Latency(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Total Nighttime Sleep(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Wake After Sleep Onset(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Children's Sleep Habits Questionnaire (CSHQ)(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Pittsburgh Sleep Quality Index(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Center for Epidemiologic Studies Depression Scale(Baseline, 2 weeks, 3 months, and 6 months after randomization)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 2 weeks, 3 months, and 6 months after randomization)