Aromatherapy for Stress and Burnout Among Healthcare Providers

Sponsor
Franklin Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT05114655
Collaborator
(none)
114
1
3
3.2
35.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Herbaceous Essential Oil Blend
  • Other: Citrus Essential Oil Blend
  • Other: Inert Oil
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Nov 11, 2021
Actual Primary Completion Date :
Feb 10, 2022
Actual Study Completion Date :
Feb 17, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-intervention score on the Maslach Burnout Inventory for Health Personnel on day 7 [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.

  2. Post-intervention score on the Profile of Mood States, abbreviated version on day 7 [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.

  3. Post-intervention score on the Depression Anxiety Stress Scale (DASS) on day 7 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Franklin Health Research Center Franklin Tennessee United States 37067

Sponsors and Collaborators

  • Franklin Health Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Franklin Health Research
ClinicalTrials.gov Identifier:
NCT05114655
Other Study ID Numbers:
  • 21-10-110
First Posted:
Nov 10, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Franklin Health Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022