The Effect of Aromatherapy on COVID-19-induced Anxiety
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
研究概览
简要总结
The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.
详细描述
After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy
- •Documented COVID-19 exposure, suspected infection, or diagnosed infection
- •Has been tested for or diagnosed with COVID-19
- •adults age 18-65 living in the US
- •understands and agrees to comply with study procedures
- •provides informed consent
排除标准
- •Smoker in household
- •Pregnant or may become pregnant
- •Difficulty breathing
- •Pain or pressure in the chest
- •Confusion
- •Hospitalization
- •Asthma, COPD, or other respiratory condition
- •demonstrated inability to comply with study procedures
- •has participated in an interventional clinical study within 31 days prior to enrollment
结局指标
主要结局
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
时间窗: Baseline and at 15 minutes
The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
时间窗: Baseline and at 15 minutes
This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.
次要结局
未报告次要终点