Essential Oils and Post COVID-19 Fatigue

Not Applicable

Completed

• Conditions: Covid19; Fatigue
• Interventions: Other: Aromatherapy; Other: Placebo

• Registration Number: NCT04980573
• Lead Sponsor: Franklin Health Research

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.

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Start: 2021-08-05
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Aromatherapy	Participants receive a bottle of plant-based oil to inhale twice daily for 14 days.
Placebo	Placebo	Participants receive a bottle of inert oil to inhale twice daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14.	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

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

Trial Locations

Locations (1)

Franklin Health Research Center; 🇺🇸 Franklin, Tennessee, United States