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

Conditions

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

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.

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

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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