Anxiety Clinical Trial
Official title:
The Effect of Aromatherapy on COVID-19-induced Anxiety
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Franklin Health Research Center | Franklin | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Franklin School of Integrative Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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