The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.
研究概览
简要总结
The purpose of this study is to assess the efficacy of plant based aromas on energy levels among otherwise healthy female survivors of COVID-19.
详细描述
After being informed about the study, participants will provide informed consent, then will be randomized into one of two groups in a 1:1 ratio. Participants will either inhale an inert blend twice a day or an active aroma twice a day for 14 days.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-49
- •Lives in the United States
- •Otherwise Healthy
- •COVID-19 Diagnosis between December 1, 2020 and March 31, 2021
- •Decreased energy or fatigue at a level that was not present prior to the diagnosis
排除标准
- •Positive COVID-19 test any time before December 1, 2020
- •Positive COVID-19 test any time after March 31, 2021
- •COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
- •Allergy to any of the ingredients
- •Pregnant, trying to conceive, or breastfeeding
- •Regular smokers in the home
- •Abnormal pulmonary function
- •Chest pain
- •Recurring headaches
- •Uncontrolled hypertension
- •Chronic Fatigue Syndrome diagnosis
- •Persistent fatigue prior to COVID-19 diagnosis
- •Hypothyroidism
研究组 & 干预措施
Intervention
Participants receive a bottle of plant-based oil to inhale twice daily for 14 days.
干预措施: Aromatherapy (Other)
Placebo
Participants receive a bottle of inert oil to inhale twice daily for 14 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.
时间窗: Baseline and Day 14
The MFSI is a validated, 83 question scale measuring fatigue levels across ten domains. Each question is scored from 0-5 on a Likert scale, with higher scores indicating higher levels of fatigue.
次要结局
- Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)(Baseline and Day 14)