- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05114655
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
-
-
Tennessee
-
Franklin, Tennessee, United States, 37067
- Franklin Health Research Center
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-
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.
|
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.
|
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.
|
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
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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