Aromatherapy for Stress and Burnout Among Healthcare Providers

March 29, 2022 updated by: Franklin Health Research

The Effects of Aromatherapy on Stress and Burnout Among Healthcare Providers During the COVID-19 Pandemic: A 3-Arm Randomized, Double Blind, Controlled Trial

The purpose of this study is to evaluate the potential for inhalation of plant-based aromas to reduce stress and burnout among healthcare professionals and staff in hospitals and urgent care centers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks/benefits, participants will provide e-sign informed consent documents and be randomized to one of three groups in a 1:1:1 ratio. Each participant will apply the assigned study oil to the jawline for inhalation three times daily for a total of 7 days.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Franklin Health Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-59
  • Lives in the United States
  • Otherwise healthy
  • Employed full time in a capacity that interacts with patients at a hospital, primary, or urgent care center that treats COVID-19 patients. Full time is defined as 35 hours or more each week.

Exclusion Criteria:

  • Positive COVID-19 test within 60 days of the study period
  • COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
  • Allergy to any of the ingredients
  • Regular smokers in the home (daily or more often)
  • Pregnant, trying to conceive, or breastfeeding
  • Existing use of an aromatherapy blend for stress management

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 1
Participants apply an herbaceous, earthy based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days.
Other: Herbaceous Essential Oil Blend
Participants are given a diluted proprietary oil blend of aromatic extracts from resins, bark, and flowers to apply three times daily for the purposes of inhalation.
Experimental: Intervention 2
Participants apply a light, citrus-based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days.
Other: Citrus Essential Oil Blend
Participants are given a diluted proprietary oil blend of aromatic extracts from citrus peel, and flowers to apply three times daily for the purposes of inhalation.
Placebo Comparator: Placebo
Participants apply an inert blend including fractionated coconut oil to the jawline three times each day for 7 days.
Other: Inert Oil
Participants are given an inert vegetable based oil blend to apply three times daily for the purposes of inhalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-intervention score on the Maslach Burnout Inventory for Health Personnel on day 7
Time Frame: Day 7
The Maslach Burnout Inventory is a 22-item scale measuring 3 constructs of burnout: emotional exhaustion, depersonalization, and personal achievement. Each item is ranked on a 7-point likert scale, scored from 0-6, with higher scores indicating higher levels of burnout.
Day 7
Post-intervention score on the Profile of Mood States, abbreviated version on day 7
Time Frame: Day 7
The abbreviated version of the profile of mood states contains 40 items across 7 constructs. Each item is scored on a 5 point scale ranging from 0-4 with higher scores indicating higher levels of each construct.
Day 7
Post-intervention score on the Depression Anxiety Stress Scale (DASS) on day 7
Time Frame: Day 7
The DASS is a 42-item scale measuring depression, anxiety, and stress. Each item is measured on a 4-point frequency scale, scored from 0-3, with higher scores indicating greater frequency of each symptom.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franklin Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

October 29, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-10-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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