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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04819594
Other study ID # STU-2020-1413
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date October 31, 2021

Study information

Verified date April 2022
Source Parkland Health and Hospital System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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: 1. Nurse identified by: - Leadership - Self-identified - SPARKS member 2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 319
Est. completion date October 31, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States Parkland Health and Hospital System Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Parkland Health and Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline, 4 hours post intervention (aromatherapy)
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