NCT04819594

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 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

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 24, 2021

Last Update Submit

April 29, 2022

Conditions

Stress Levels

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Study Group

EXPERIMENTAL

Nurses will wear the Elequil aromatabs ® (100% pure essential oil) over a four-hour period

Other: Elequil aromatabs ®

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses volunteering to participate in the study and are experiencing stress while at work

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

Study Officials

  • Justin Buchert, MSN, M.Ed., MS, RN

    Parkland Health and Hospital System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quality Specialist

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

June 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 31, 2021

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)