The Effect of Aromatherapy on COVID-19-induced Anxiety

Not Applicable

• Conditions: Covid19; Anxiety; Stress
• Interventions: Other: Control Blend; Other: Essential Oil Blend

• Registration Number: NCT04495842
• Lead Sponsor: Franklin Health Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-03
• Study Start: 2020-10-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control Blend	Participants receive an inert comparison to inhale for 15 minutes.
Intervention	Essential Oil Blend	Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants.

Primary Outcome Measures

Name	Time	Method
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes	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)	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.

Trial Locations

Locations (1)

Franklin Health Research Center; 🇺🇸 Franklin, Tennessee, United States