The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Primary Purpose
Nursing Personnel
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oil Inhalation Patch
Sponsored by
About this trial
This is an interventional other trial for Nursing Personnel focused on measuring Essential Oil Inhalation Patches, Essential oil and nursing stress, Medical-Surgical unit
Eligibility Criteria
Inclusion Criteria: Full time employee (Nurse, LPN, or LNA) working on L3WD and L4WC At least 18 years of age Exclusion Criteria: Pregnant/breastfeeding or planning to become pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Essential Oil Ptach
Arm Description
The nursing staff will wear an essential oil patch for 2 weeks.
Outcomes
Primary Outcome Measures
Change in baseline perceived stress as measured by the Perceived Stress Scale
Scores are measured on 0-4 scale with 0 indicating never and higher scores are more frequent.
Secondary Outcome Measures
Full Information
NCT ID
NCT06053450
First Posted
August 10, 2023
Last Updated
October 24, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT06053450
Brief Title
The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Official Title
The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this clinical study is to compare the use of an essential oil inhalation patch in medical surgical nurses on perceived burn-out and stress.
The main question is can essential oil inhalation patches decrease perceived burn-out and stress.
Participants will
Take part in the study over 30 days, alternating weeks, resulting in each participant using six patches over six shifts.
Complete anonymous Perceived Stress Survey (PSS) before the study begins and at the conclusion of the study.
Participants will also complete a (different) survey after two weeks.
Detailed Description
Essential Oil inhalation patches are a nonpharmacological option that is worn by the nursing staff on an inpatient medical-surgical unit to determine the efficacy of patch on staff perceived stress & burn-out levels. Each participant will wear a new patch during six work shifts. Location is on chest or the ID badge area where it can be easily accessed to. The patch provides up to 8 hours of aromatic support. The patches use a unique patented technology that slows the release of the aromatic molecules while maintaining the purity and vitality of the essential oil. The FDA approved medical adhesive patches are roughly 1x1" in size, and are inhalation only- no contact of essential oils on skin. The patch is portable and discreet. No overwhelming aroma for others. The patch has directions for use on package with an expiration date. Used for a non-specific purpose for stress reduction environment for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Personnel
Keywords
Essential Oil Inhalation Patches, Essential oil and nursing stress, Medical-Surgical unit
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Essential Oil Ptach
Arm Type
Experimental
Arm Description
The nursing staff will wear an essential oil patch for 2 weeks.
Intervention Type
Other
Intervention Name(s)
Oil Inhalation Patch
Other Intervention Name(s)
Quella; Elequil
Intervention Description
Each participant will wear a patch for a work week (3 worked shifts) and then no patch is worn for a week. This alternates for a total of a month.
Primary Outcome Measure Information:
Title
Change in baseline perceived stress as measured by the Perceived Stress Scale
Description
Scores are measured on 0-4 scale with 0 indicating never and higher scores are more frequent.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Full time employee (Nurse, LPN, or LNA) working on L3WD and L4WC
At least 18 years of age
Exclusion Criteria:
Pregnant/breastfeeding or planning to become pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel G. Blier, MSN,RN
Phone
16036508085
Email
Rachel.G.Blier@hitchcock.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel G. Blier, MSN,RN
Organizational Affiliation
DHMC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16705307
Citation
Spence Laschinger HK, Leiter MP. The impact of nursing work environments on patient safety outcomes: the mediating role of burnout/engagement. J Nurs Adm. 2006 May;36(5):259-67. doi: 10.1097/00005110-200605000-00019.
Results Reference
background
Learn more about this trial
The Effect of Essential Oil Inhalation Patches on Perceived Burn-out & Stress on an Inpatient Medical-surgery Unit.
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