- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04980573
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
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
-
-
Tennessee
-
Franklin, Tennessee, United States, 37067
- Franklin Health Research Center
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-
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.
|
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.
|
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
Collaborators
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.
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