Aromatherapy for Stress and Burnout Among Healthcare Providers

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114655
• Other study ID #: 21-10-110
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2022
• Source: Franklin Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 17, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Professional
• Burnout, Psychological
• Occupational Stress
• Stress

Intervention

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.
• 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.
• Inert Oil
Participants are given an inert vegetable based oil blend to apply three times daily for the purposes of inhalation.

Locations

Country	Name	City	State
United States	Franklin Health Research Center	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-intervention score on the Maslach Burnout Inventory for Health Personnel on 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
Primary	Post-intervention score on the Profile of Mood States, abbreviated version on 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
Primary	Post-intervention score on the Depression Anxiety Stress Scale (DASS) on 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