Essential Oils and Post COVID-19 Fatigue

January 20, 2022 updated by: Franklin Health Research

The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial

The purpose of this study is to assess the efficacy of plant based aromas on energy levels among otherwise healthy female survivors of COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study, participants will provide informed consent, then will be randomized into one of two groups in a 1:1 ratio. Participants will either inhale an inert blend twice a day or an active aroma twice a day for 14 days.

Study Type

Interventional

Enrollment (Actual)

47

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 Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • 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

19 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19-49
  • Lives in the United States
  • Otherwise Healthy
  • COVID-19 Diagnosis between December 1, 2020 and March 31, 2021
  • Decreased energy or fatigue at a level that was not present prior to the diagnosis

Exclusion Criteria:

  • Positive COVID-19 test any time before December 1, 2020
  • Positive COVID-19 test any time after March 31, 2021
  • COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
  • Allergy to any of the ingredients
  • Pregnant, trying to conceive, or breastfeeding
  • Regular smokers in the home
  • Abnormal pulmonary function
  • Chest pain
  • Recurring headaches
  • Uncontrolled hypertension
  • Chronic Fatigue Syndrome diagnosis
  • Persistent fatigue prior to COVID-19 diagnosis
  • Hypothyroidism

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Participants receive a bottle of plant-based oil to inhale twice daily for 14 days.
Other: Aromatherapy
The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.
PLACEBO_COMPARATOR: Placebo
Participants receive a bottle of inert oil to inhale twice daily for 14 days.
Other: Placebo
The placebo intervention consists of inhaling an oil extracted from inert plant matter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.
Time Frame: Baseline and Day 14
The MFSI is a validated, 83 question scale measuring fatigue levels across ten domains. Each question is scored from 0-5 on a Likert scale, with higher scores indicating higher levels of fatigue.
Baseline and Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline and Day 14
This survey includes 9 questions regarding levels of depression. Each question is scored from 0-3 on a Likert scale, with higher scores indicating higher levels of depression.
Baseline and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Collaborators

Young Living Essential Oils

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)

August 5, 2021

Primary Completion (ACTUAL)

November 30, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (ACTUAL)

July 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-07-0300

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.

Clinical Trials on Fatigue

Clinical Trials on Aromatherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe