Stress LevelsNCT04819594
The Effects of Aromatherapy on the Stress Levels of Nurses Working in an Urban, Safety-Net Community Hospital
A study testing Elequil aromatabs ® in people with Stress Levels, run by Parkland Health and Hospital System at 1 site in United States.
Trial summary
Parkland Hospital inpatient nursing staff will be the focus of this study. This project aims to investigate the use of lavender on the stress levels associated with the nursing role. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Levels
- What is being tested?
- Elequil aromatabs ®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Oct 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses volunteering to participate in the study and are experiencing stress while at work
Who cannot join
- Known allergies or sensitivities to aromatherapy products, a history of respiratory problems, asthma, allergies to fragrance, or lost sense of smell. Those nurses who have had serious disease complications will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75235
About this study
Parkland Hospital inpatient nursing staff will be the focus of this study. This project aims to investigate the use of lavender on the stress levels associated with the nursing role. Nurses will wear the Elequil aromatabs ® over a four-hour period and a post survey will be given to assess root cause of stress and changes related to intervention.
Read the detailed description
Nurses today are facing unprecedented patient acuities, burnout, fear, uncertainty, a continuously evolving workflow and nursing shortages, Therefore, workplace-related stress has become one of today's most serious occupational hazards. Aromatherapy can be a convenient, inexpensive, and non-invasive method of stress relief. There is little research regarding the efficacy of aromatherapy by means of inhaling essential oils in reducing workplace stress-related symptoms among nurses. Therefore, this study will examine the efficacy of lavender-scented aromatherapy tabs (Elequil ® aromatabs ®) in reducing job stress-related symptoms among nurses.
The study for the participants goes as follows:
- Nurse identified by:
- Leadership
- Self-identified
- SPARKS member
- Process:
- Identified nurse will be informed and consented regarding the study.
- An aromatab will be given to the nurse.
- They will place the aromatab on their uniform top to allow for continuous exposure to the scent.
- Four (4) hours later - nurse completes survey as to the effects of the aromatab
- Completed survey is placed in research file at charge nurse desk in opaque folder.
Data to be used within the research project will be obtained from the collected survey forms.
Recruitment will be completed face-to-face between the SPARKS team member, leadership, or self -identification of the potential subject. Considerable care will be taken so that the person contacted does not feel pressured to participate.
The research team will meet prior to enrolling the first participant, during and upon completion of data collection. Any safety concerns will be addressed at those times. At any time during data collection, the PI's or any study team members may request that the team meets to address a safety concern. Study participants will be assured of anonymity and confidentiality of the data and they will also be reminded that they can withdraw from the study at any time.
- Conditions
- Stress Levels
- Being tested
- Elequil aromatabs ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elequil aromatabs ®Other
100% pure essential oils in a unique controlled delivery system for relaxation, comfort, and sleep. Scented tabs on a self-adhesive label will be placed on the nurses's uniform for 4 hours to provide aromatherapy for the clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Nurses will wear the Elequil aromatabs ® (100% pure essential oil) over a four-hour period Receives: Other: Elequil aromatabs ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in stress levels as measured by Nurse Survey
Nurse Survey is used for measuring the level of stress in nurses who agree that the intervention reduced their stress levels. Possible scores range from 0 - 10 with higher scores indicating severe stress levels (worse outcome).
Measured: Baseline, 4 hours post intervention (aromatherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress LevelsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkland Health and Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Buchert, Parkland Health and Hospital System
- Investigators
- Justin Buchert, MSN, M.Ed., MS, RN, Principal investigator, Parkland Health and Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819594
- Sponsor's protocol ID
- STU-2020-1413
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2021
- Last updated
- 2 May 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aromatherapy on the Stress Levels of Nurses Working in an Urban, Safety-Net Community Hospital
- ClinicalTrials.gov ID
- NCT04819594
- Acronym / sponsor ID
- STU-2020-1413
- Conditions
- Stress Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Parkland Health and Hospital SystemUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 29 Mar 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.
Parkland Hospital inpatient nursing staff will be the focus of this study. This project aims to investigate the use of lavender on the stress levels associated with the nursing role. Nurses will wear the Elequil aromatabs ® over a four-hour period and a post survey will be given to assess root cause of stress and changes related to intervention.
Detailed description
Nurses today are facing unprecedented patient acuities, burnout, fear, uncertainty, a continuously evolving workflow and nursing shortages, Therefore, workplace-related stress has become one of today's most serious occupational hazards. Aromatherapy can be a convenient, inexpensive, and non-invasive method of stress relief. There is little research regarding the efficacy of aromatherapy by means of inhaling essential oils in reducing workplace stress-related symptoms among nurses. Therefore, this study will examine the efficacy of lavender-scented aromatherapy tabs (Elequil ® aromatabs ®) in reducing job stress-related symptoms among nurses.
The study for the participants goes as follows:
- Nurse identified by:
- Leadership
- Self-identified
- SPARKS member
- Process:
- Identified nurse will be informed and consented regarding the study.
- An aromatab will be given to the nurse.
- They will place the aromatab on their uniform top to allow for continuous exposure to the scent.
- Four (4) hours later - nurse completes survey as to the effects of the aromatab
- Completed survey is placed in research file at charge nurse desk in opaque folder.
Data to be used within the research project will be obtained from the collected survey forms.
Recruitment will be completed face-to-face between the SPARKS team member, leadership, or self -identification of the potential subject. Considerable care will be taken so that the person contacted does not feel pressured to participate.
The research team will meet prior to enrolling the first participant, during and upon completion of data collection. Any safety concerns will be addressed at those times. At any time during data collection, the PI's or any study team members may request that the team meets to address a safety concern. Study participants will be assured of anonymity and confidentiality of the data and they will also be reminded that they can withdraw from the study at any time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Elequil aromatabs ®Nurses will wear the Elequil aromatabs ® (100% pure essential oil) over a four-hour period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses volunteering to participate in the study and are experiencing stress while at work
Key exclusion criteria (1 listed)
- Known allergies or sensitivities to aromatherapy products, a history of respiratory problems, asthma, allergies to fragrance, or lost sense of smell. Those nurses who have had serious disease complications will also be excluded from the study.
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 |
|---|---|---|
| Elequil aromatabs ®100% pure essential oils in a unique controlled delivery system for relaxation, comfort, and sleep. Scented tabs on a self-adhesive label will be placed on the nurses's uniform for 4 hours to provide aromatherapy for the clinical setting. | Other | Study Group |
Primary outcome
Mean change in stress levels as measured by Nurse Survey
Time frame: Baseline, 4 hours post intervention (aromatherapy)
Nurse Survey is used for measuring the level of stress in nurses who agree that the intervention reduced their stress levels. Possible scores range from 0 - 10 with higher scores indicating severe stress levels (worse outcome).
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 2 May 2022.
- Individual participant dataSharing planned: No
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PRIMARY HYPERTENSION
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.
Justin Buchert, MSN, M.Ed., MS, RN principal investigator
Parkland Health and Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elequil aromatabs ® in people with Stress Levels, run by Parkland Health and Hospital System 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 1 inclusion and 1 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 2 May 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. 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?
Mean change in stress levels as measured by Nurse Survey (time frame: Baseline, 4 hours post intervention (aromatherapy)). 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 2 May 2022.