- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495842
The Effect of Aromatherapy on COVID-19-induced Anxiety
July 27, 2021 updated by: Franklin Health Research
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: PI
- Phone Number: 6152613116
- Email: info@franklinhealth.org
Study Locations
-
-
Tennessee
-
Franklin, Tennessee, United States, 37067
- Recruiting
- Franklin Health Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Participants receive an active essential oil blend to inhale for 15 minutes.
The blend contains plant based oils sourced from flowers and citrus plants.
|
5 drops of on a tester strip
|
PLACEBO_COMPARATOR: Control
Participants receive an inert comparison to inhale for 15 minutes.
|
5 drops on a tester strip
|
What is the study measuring?
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
Time Frame: 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.
|
Baseline and at 15 minutes
|
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
Time Frame: 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.
|
Baseline and at 15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
March 31, 2022
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
July 31, 2020
First Posted (ACTUAL)
August 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-7-5600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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