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The Effect of Aromatherapy on COVID-19-induced Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495842
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Franklin School of Integrative Health Sciences

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.

Condition or disease Intervention/treatment Phase
Stress Covid19 Anxiety Other: Essential Oil Blend Other: Control Blend Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Aromatherapy on COVID-19-induced Anxiety
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Other: Essential Oil Blend
5 drops of on a tester strip

Placebo Comparator: Control
Participants receive an inert comparison to inhale for 15 minutes.
Other: Control Blend
5 drops on a tester strip




Primary Outcome Measures :
  1. 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 ]
    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.

  2. Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS) [ Time Frame: Baseline and at 15 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495842


Contacts
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Contact: PI 6152613116 info@franklinhealth.org

Locations
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United States, Tennessee
Franklin Health Research Center Recruiting
Franklin, Tennessee, United States, 37067
Contact: Jessie Hawkins, PhD    615-642-1919    j.hawkins@franklinhealth.org   
Sponsors and Collaborators
Franklin School of Integrative Health Sciences
Investigators
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Principal Investigator: Jessie Hawkins, PhD Franklin School of Integrative Health Sciences
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Responsible Party: Franklin School of Integrative Health Sciences
ClinicalTrials.gov Identifier: NCT04495842    
Other Study ID Numbers: 20-7-5600
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin School of Integrative Health Sciences:
aromatherapy
essential oils
environmental health
Additional relevant MeSH terms:
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COVID-19
Anxiety Disorders
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Mental Disorders