NCT05114655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

October 29, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

aromatherapyessential oils

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Intervention 1

EXPERIMENTAL

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

Intervention 2

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Inert Oil

Interventions

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 1

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 2

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

Placebo

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin Health Research Center

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Burnout, ProfessionalOccupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

November 11, 2021

Primary Completion

February 10, 2022

Study Completion

February 17, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations