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Essential Oils and Post COVID-19 Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04980573
Recruitment Status : Completed
First Posted : July 28, 2021
Last Update Posted : January 24, 2022
Sponsor:
Collaborator:
Young Living Essential Oils
Information provided by (Responsible Party):
Franklin Health Research

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Fatigue Other: Aromatherapy Other: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial
Actual Study Start Date : August 5, 2021
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self-representation of gender and is restricted to women.
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04980573


Locations
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United States, Tennessee
Franklin Health Research Center
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Franklin Health Research
Young Living Essential Oils
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Franklin Health Research
ClinicalTrials.gov Identifier: NCT04980573    
Other Study ID Numbers: 21-07-0300
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Health Research:
essential oils
aromatherapy
energy
Additional relevant MeSH terms:
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COVID-19
Fatigue
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases