The Effects of Aromatherapy and Music Listening on Sleep and Cerebral Oxygen Levels in Children With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time Spent in Bed
研究概览
简要总结
Purpose: This study aimed to compare the effects of aromatherapy and music listening with routine care on sleep parameters and cerebral oxygenation in children with epilepsy. Design and methods: This randomized controlled experimental study was conducted between February and December 2023 with children diagnosed with epilepsy living in Malatya Province and surrounding regions. The sample consisted of 90 children allocated to aromatherapy (n = 30), music listening (n = 30), and control (n = 30) groups. Children in the intervention groups received aromatherapy or music listening, whereas the control group received routine care only. Data were collected using the Patient Introduction and Follow-up Form, actigraphy, and the Cerebral Oxygen Monitoring Form. One-way ANOVA, Kruskal-Wallis, chi-square, Mann-Whitney U, LSD, and Dunnett's C tests were used for data analysis. Results: Aromatherapy was associated with higher cerebral oxygen levels, longer time spent in bed, longer sleep duration, higher sleep efficiency, and lower sleep onset latency (p < 0.05). Similarly, music listening was associated with higher cerebral oxygen levels, longer sleep duration, and higher sleep efficiency (p < 0.05). Conclusion: Aromatherapy and music listening may improve selected sleep parameters and cerebral oxygenation in children with epilepsy. Practice implications: Aromatherapy and music listening may be considered supportive, non-pharmacological interventions for improving sleep and cerebral oxygenation in pediatric epilepsy care.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generalized tonic-clonic seizure,
- •Children who take at least one antiepileptic drug.
排除标准
- •Children with hearing problems,
- •Children with resistant epilepsy,
- •Children diagnosed with sleep disorders,
- •Children diagnosed with neurological, psychiatric, or medical disorders other than epilepsy,
- •Children with allergies,
- •Children with impaired sense of smell,
- •Children whose parents did not give consent were excluded from the study.
研究组 & 干预措施
Aromatherapy Group
Before evening sleep, lavender aromatherapy was administered by inhalation for 30 minutes using a scented pillow. NIRS monitoring was initiated concurrently with the 30-minute aromatherapy intervention and continued for a total of 150 minutes.
干预措施: Aromatherapy (Other)
Music Listening Group
Before evening sleep, music selected by the child or parent was played at 45-65 dB for 30 minutes. NIRS monitoring was initiated concurrently with the 30-minute music-listening intervention and continued for a total of 150 minutes.
干预措施: Music Listening (Other)
Control Group
Routine care only
结局指标
主要结局
Time Spent in Bed
时间窗: 24-hour actigraphy monitoring period
Time spent in bed was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total time the child spent in bed during the monitored sleep period and was expressed in hours.
Awakening Time During Sleep
时间窗: 24-hour actigraphy monitoring period
Awakening time during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total duration of wakefulness occurring after sleep onset and before the end of the sleep period and was expressed in
Number of Awakenings During Sleep
时间窗: 24-hour actigraphy monitoring period
The number of awakenings during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the number of episodes scored as wakefulness occurring during the monitored sleep period and was reported as a count.
Sleep Duration
时间窗: 24-hour actigraphy monitoring period
Sleep duration was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total amount of time scored as sleep during the monitored sleep period and was expressed in hours.
Sleep Onset Latency
时间窗: 24-hour actigraphy monitoring period
Sleep onset latency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the time from the beginning of the sleep period to sleep onset and was expressed in minutes.
Sleep Efficiency
时间窗: 24-hour actigraphy monitoring period
Sleep efficiency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the percentage of time spent asleep relative to the total time spent in bed during the monitored sleep period and was expressed as a percentage (%).
Regional Cerebral Oxygen Saturation (rSO₂)
时间窗: 150-minute NIRS monitoring period
Regional cerebral oxygen saturation (rSO₂) was assessed noninvasively using near-infrared spectroscopy (NIRS) with the INVOS 5100C system and compatible INVOS pediatric sensors. rSO₂ values were recorded at 30, 60, 90, 120, and 150 minutes during the monitoring period. The five measurements were averaged to obtain one mean rSO₂ value for each participant. Regional cerebral oxygen saturation was expressed as a percentage (%).
次要结局
未报告次要终点
研究者
Mehmet Ali AKDEMİR
PhD Student
Kafkas University