- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04934969
The Adjunctive Use of Lavender and Peppermint Essential Oils (aromatherapy)
The Adjunctive Use of Lavender and Peppermint Essential Oils to Manage Nausea, Pain, and Anxiety in an Adult Orthopedic Population
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Following review of records for eligibility and consent obtained during pre op visit subjects will be enrolled in study post op they will validate desire to participate and chose to inhale (2 drops of essential oil on cotton ball in a plastic bag) lavender for discomfort or anxiety or peppermint for GI distress
Visual analogue scales will be used to rate discomfort , anxiety and nausea
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- elective joint replacement able to read and speak English and describe study procedures
Exclusion Criteria:
pregnancy
- unable to smell, sensitivity to fragrances asthma or breathing problems have smoke or vaped in last 2 weeks if atrial fibrillation history no peppermint uncontrolled hypertension above 160/100 non employees of UH or students of CWRU
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Use of lavender and peppermint essential oils pre and post
passive inhalation of either peppermint and lavender essential oil with pre and post test measure
|
passive inhalation aromatherapy following joint surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
discomfort, anxiety, or GI distress
Time Frame: total of 90 minutes
|
visual analog sale
|
total of 90 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Denise Kresevic, PhD, University Hospitals Cleveland Medical Center
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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