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The Effect of Aromatherapy on COVID-19-induced Anxiety

Primary Purpose

Stress, Covid19, Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Essential Oil Blend
Control Blend
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring aromatherapy, essential oils, environmental health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Franklin Health Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

Participants receive an inert comparison to inhale for 15 minutes.

Outcomes

Primary Outcome Measures

Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
July 27, 2021
Sponsor
Franklin Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT04495842
Brief Title
The Effect of Aromatherapy on COVID-19-induced Anxiety
Official Title
The Effect of Aromatherapy on COVID-19-induced Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Covid19, Anxiety
Keywords
aromatherapy, essential oils, environmental health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants receive an inert comparison to inhale for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Essential Oil Blend
Intervention Description
5 drops of on a tester strip
Intervention Type
Other
Intervention Name(s)
Control Blend
Intervention Description
5 drops on a tester strip
Primary Outcome Measure Information:
Title
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
Description
The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
Time Frame
Baseline and at 15 minutes
Title
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
Description
This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.
Time Frame
Baseline and at 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PI
Phone
6152613116
Email
info@franklinhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie Hawkins, PhD
Organizational Affiliation
Franklin Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessie Hawkins, PhD
Phone
615-642-1919
Email
j.hawkins@franklinhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Aromatherapy on COVID-19-induced Anxiety

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