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Essential Oils and Post COVID-19 Fatigue

Primary Purpose

Covid19, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy
Placebo
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring essential oils, aromatherapy, energy

Eligibility Criteria

19 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Franklin Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Participants receive a bottle of plant-based oil to inhale twice daily for 14 days.

Participants receive a bottle of inert oil to inhale twice daily for 14 days.

Outcomes

Primary Outcome Measures

Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at 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

Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)
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.

Full Information

First Posted
July 26, 2021
Last Updated
January 20, 2022
Sponsor
Franklin Health Research
Collaborators
Young Living Essential Oils
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1. Study Identification

Unique Protocol Identification Number
NCT04980573
Brief Title
Essential Oils and Post COVID-19 Fatigue
Official Title
The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research
Collaborators
Young Living Essential Oils

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Fatigue
Keywords
essential oils, aromatherapy, energy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants receive a bottle of plant-based oil to inhale twice daily for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a bottle of inert oil to inhale twice daily for 14 days.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Intervention Description
The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo intervention consists of inhaling an oil extracted from inert plant matter.
Primary Outcome Measure Information:
Title
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.
Description
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.
Time Frame
Baseline and Day 14
Secondary Outcome Measure Information:
Title
Change from baseline to day 14 on the Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Baseline and Day 14

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Eligibility is based on self-representation of gender and is restricted to women.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Essential Oils and Post COVID-19 Fatigue

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