The Effect of Aromatherapy on COVID-19-induced Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Aromatherapy on COVID-19-induced Anxiety

Conditions
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Stress, Covid19, Anxiety

Intervention / Treatment
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* Other: Essential Oil Blend
* Other: Control Blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants. | Other: Essential Oil Blend<br>* 5 drops of on a tester strip<br>|
| Placebo Comparator: Control<br>Participants receive an inert comparison to inhale for 15 minutes. | Other: Control Blend<br>* 5 drops on a tester strip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) 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. | Baseline and at 15 minutes | 
| Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS) | 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. | Baseline and at 15 minutes | 

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