The Effect of Aroma on Anxiety Among Children With Autism.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- 39-Question Spence Children's Anxiety Scale (SCAS)
研究概览
简要总结
This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.
详细描述
Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder.
The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils.
Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 6-11 years old at enrollment
- •diagnosed with an autism spectrum disorder
排除标准
- •mast cell activation syndrome
- •history of adverse response to essential oil inhalation
结局指标
主要结局
39-Question Spence Children's Anxiety Scale (SCAS)
时间窗: baseline and day 35
The Spence Children's Anxiety Scale collects parent-reported signs and symptoms of anxiety at baseline and again at the end of each week of the intervention. Each item is scored as (0) never, (1) sometimes (2) often, or (3)always. The total score ranges from 0-114, with higher scores indicating higher levels of anxiety.
次要结局
未报告次要终点