StressNCT05114655
Aromatherapy for Stress and Burnout Among Healthcare Providers
A study testing Herbaceous Essential Oil Blend, Citrus Essential Oil Blend and Inert Oil in people with Stress and Burnout, Professional, run by Nutraceuticals Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional, Stress, Job
- What is being tested?
- Herbaceous Essential Oil Blend, Citrus Essential Oil Blend and Inert Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Health Research Center
Franklin, Tennessee, 37067
About this study
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
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.
Read the 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.
- Conditions
- Stress, Burnout, Professional, Stress, Job
- Being tested
- Herbaceous Essential Oil Blend, Citrus Essential Oil Blend, Inert Oil
- Keywords
- aromatherapy, essential oils
- Medical subject headings
- Burnout, Professional, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbaceous Essential Oil BlendOther
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 BlendOther
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 OilOther
Participants are given an inert vegetable based oil blend to apply three times daily for the purposes of inhalation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Inert Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start11 Nov 2021
- Primary completion10 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114655
- Sponsor's protocol ID
- 21-10-110
- Status last verified
- Mar 2022
- First submitted
- 29 Oct 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05114655
- Acronym / sponsor ID
- 21-10-110
- Conditions
- Stress, Burnout, Professional, Stress, Job
- Keywords
- aromatherapy, essential oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Other: Herbaceous Essential Oil BlendParticipants apply an herbaceous, earthy based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days. |
| Intervention 2 | Experimental | Other: Citrus Essential Oil BlendParticipants apply a light, citrus-based essential oil blend diluted in fractionated coconut oil to the jawline three times each day for 7 days. |
| Placebo | Placebo comparator | Other: Inert OilParticipants apply an inert blend including fractionated coconut oil to the jawline three times each day for 7 days. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbaceous Essential Oil BlendParticipants 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. | Other | Intervention 1 |
| Citrus Essential Oil BlendParticipants 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. | Other | Intervention 2 |
| Inert OilParticipants are given an inert vegetable based oil blend to apply three times daily for the purposes of inhalation. | Other | Placebo |
Primary outcome
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.
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbaceous Essential Oil Blend, Citrus Essential Oil Blend and Inert Oil in people with Stress and Burnout, Professional, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention score on the Maslach Burnout Inventory for Health Personnel on day 7 (time frame: Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.