The Effect of Aromatherapy on COVID-19-induced Anxiety

Anxiety Clinical Trial

Official title:

The Effect of Aromatherapy on COVID-19-induced Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04495842
• Other study ID #: 20-7-5600
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2021
• Source: Franklin School of Integrative Health Sciences
• Contact: PI
• Phone: 6152613116
• Email: info[@]franklinhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Covid19
• Stress

Intervention

Other:
• Essential Oil Blend
5 drops of on a tester strip
• Control Blend
5 drops on a tester strip

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin School of Integrative Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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