The Effect of Aromatherapy on COVID-19-induced Anxiety

NCT04495842 | Unknown

• 1 other identifier: 20-7-5600
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

aromatherapy; essential oils; environmental health

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and at 15 minutes

• 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.

  Baseline and at 15 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Participants receive an inert comparison to inhale for 15 minutes.

Other: Control Blend

Interventions

Essential Oil Blend OTHER

5 drops of on a tester strip

Intervention

Control Blend OTHER

5 drops on a tester strip

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Anxiety Disorders

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; Mental Disorders

Study Officials

• Jessie Hawkins, PhD

  Nutraceuticals Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PI

CONTACT

6152613116; info@franklinhealth.org

Study Design

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

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 3, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)