Essential Oils and Post COVID-19 Fatigue

NCT04980573 | Completed

• 1 other identifier: 21-07-0300
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Fatigue

Keywords

essential oils; aromatherapy; energy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 14

Secondary Outcomes (1)

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

  Baseline and Day 14

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Aromatherapy

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Aromatherapy OTHER

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

Intervention

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 49 Years
• Gender Eligibility Details: Eligibility is based on self-representation of gender and is restricted to women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead
• Young Living Essential Oils: collaborator

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

COVID-19; Fatigue

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 28, 2021
• Study Start: August 5, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)