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Clinical Trials/NCT05114655
NCT05114655
Completed
Not Applicable

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

Franklin Health Research1 site in 1 country114 target enrollmentNovember 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Franklin Health Research
Enrollment
114
Locations
1
Primary Endpoint
Post-intervention score on the Depression Anxiety Stress Scale (DASS) on day 7
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2021
End Date
February 17, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Franklin Health Research
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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