The Effect of Aromatherapy on COVID-19-induced Anxiety

NCT ID: NCT04495842

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.

Conditions

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Stress Covid19 Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Essential Oil Blend

Intervention Type OTHER

5 drops of on a tester strip

Control

Participants receive an inert comparison to inhale for 15 minutes.

Group Type PLACEBO_COMPARATOR

Control Blend

Intervention Type OTHER

5 drops on a tester strip

Interventions

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Essential Oil Blend

5 drops of on a tester strip

Intervention Type OTHER

Control Blend

5 drops on a tester strip

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutraceuticals Research Institute

Locations

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Franklin Health Research Center

Franklin, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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PI

Role: CONTACT

6152613116

Facility Contacts

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Jessie Hawkins, PhD

Role: primary

615-642-1919

Other Identifiers

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20-7-5600

Identifier Type: -

Identifier Source: org_study_id

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