Recruiting

Aromatherapy

Sponsor:

Nutraceuticals Research Institute

Code:

NCT04495842

Conditions

Stress

Covid19

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Essential Oil Blend

Control Blend

Study Details

Brief summary:

The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.

Conditions

Stress

Covid19

Anxiety

Study ID

NCT04495842

Start date

Oct 1, 2020

Status verified date

Jul, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Otherwise healthy
  • Documented COVID-19 exposure, suspected infection, or diagnosed infection
  • Has been tested for or diagnosed with COVID-19
  • adults age 18-65 living in the US
  • understands and agrees to comply with study procedures
  • provides informed consent

Exclusion Criteria:

  • Smoker in household
  • Pregnant or may become pregnant
  • Difficulty breathing
  • Pain or pressure in the chest
  • Confusion
  • Hospitalization
  • Asthma, COPD, or other respiratory condition
  • demonstrated inability to comply with study procedures
  • has participated in an interventional clinical study within 31 days prior to enrollment

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants.

placebo comparator: Control

Participants receive an inert comparison to inhale for 15 minutes.

Interventions

Essential Oil Blend

5 drops of on a tester strip

Control Blend

5 drops on a tester strip

Primary outcome measure

  • Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes [ Time Frame: Baseline and at 15 minutes ]
  • Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS) [ Time Frame: Baseline and at 15 minutes ]

Central Contacts and Locations

Central contacts

PI

6152613116info@franklinhealth.org

Locations

Franklin Health Research Center

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Jessie Hawkins, PhD

615-642-1919j.hawkins@franklinhealth.org

More Information

Sponsor

Nutraceuticals Research Institute

Last update posted

Aug 2, 2021

Last verified

Jul, 2021

Keywords

  • aromatherapy
  • essential oils
  • environmental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nutraceuticals Research Institute on 2021-08-02.