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Aromatherapy for Stress and Burnout Among Healthcare Providers

Primary Purpose

Stress, Burnout, Professional, Stress, Job

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Herbaceous Essential Oil Blend
Citrus Essential Oil Blend
Inert Oil
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring aromatherapy, essential oils

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Franklin Health Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Intervention 1

Intervention 2

Placebo

Arm Description

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 apply a light, citrus-based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days.

Participants apply an inert blend including fractionated coconut oil to the jawline three times each day for 7 days.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 29, 2021
Last Updated
March 29, 2022
Sponsor
Franklin Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT05114655
Brief Title
Aromatherapy for Stress and Burnout Among Healthcare Providers
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout, Professional, Stress, Job
Keywords
aromatherapy, essential oils

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
Participants apply an herbaceous, earthy based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days.
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
Participants apply a light, citrus-based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants apply an inert blend including fractionated coconut oil to the jawline three times each day for 7 days.
Intervention Type
Other
Intervention Name(s)
Herbaceous Essential Oil Blend
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Citrus Essential Oil Blend
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inert Oil
Intervention Description
Participants are given an inert vegetable based oil blend to apply three times daily for the purposes of inhalation.
Primary Outcome Measure Information:
Title
Post-intervention score on the Maslach Burnout Inventory for Health Personnel on day 7
Description
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.
Time Frame
Day 7
Title
Post-intervention score on the Profile of Mood States, abbreviated version on day 7
Description
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.
Time Frame
Day 7
Title
Post-intervention score on the Depression Anxiety Stress Scale (DASS) on day 7
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Franklin Health Research Center
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Aromatherapy for Stress and Burnout Among Healthcare Providers

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