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OpenTrials
Completed

NCT Number: NCT04980573

Essential Oils and Post COVID-19 Fatigue

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Fatigue Infections Lung Diseases Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

19 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy

Other

The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.

Placebo

Other

The placebo intervention consists of inhaling an oil extracted from inert plant matter.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Collaborators

  • Young Living Essential Oils

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 28, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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