Essential Oils and Post COVID-19 Fatigue

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial

Conditions
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Covid19, Fatigue

Intervention / Treatment
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* Other: Aromatherapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants receive a bottle of plant-based oil to inhale twice daily for 14 days. | Other: Aromatherapy<br>* The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.<br>|
| Placebo Comparator: Placebo<br>Participants receive a bottle of inert oil to inhale twice daily for 14 days. | Other: Placebo<br>* The placebo intervention consists of inhaling an oil extracted from inert plant matter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at 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. | Baseline and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9) | This survey includes 9 questions regarding levels of depression. Each question is scored from 0-3 on a Likert scale, with higher scores indicating higher levels of depression. | Baseline and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential oils, aromatherapy, energy