- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819594
The Effects of Aromatherapy on the Stress Levels of Nurses Working in an Urban, Safety-Net Community Hospital
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Parkland Health and Hospital System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nurses volunteering to participate in the study and are experiencing stress while at work
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Group
Nurses will wear the Elequil aromatabs ® (100% pure essential oil) over a four-hour period
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, 4 hours post intervention (aromatherapy)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Justin Buchert, MSN, M.Ed., MS, RN, Parkland Health and Hospital System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU-2020-1413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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