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The Adjunctive Use of Lavender and Peppermint Essential Oils (aromatherapy)

Primary Purpose

Joint Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adjunctive use of lavender and peppermint essential oils
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Joint Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of ClevelandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of lavender and peppermint essential oils pre and post

Arm Description

passive inhalation of either peppermint and lavender essential oil with pre and post test measure

Outcomes

Primary Outcome Measures

discomfort, anxiety, or GI distress
visual analog sale

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
January 31, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04934969
Brief Title
The Adjunctive Use of Lavender and Peppermint Essential Oils
Acronym
aromatherapy
Official Title
The Adjunctive Use of Lavender and Peppermint Essential Oils to Manage Nausea, Pain, and Anxiety in an Adult Orthopedic Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will use passive inhalation of lavender for discomfort, anxiety and peppermint for nausea following joint replacement and spine surgery
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
feasibility of using essential oils post joint replacement surgery and trends toward relief of symptoms
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of lavender and peppermint essential oils pre and post
Arm Type
Experimental
Arm Description
passive inhalation of either peppermint and lavender essential oil with pre and post test measure
Intervention Type
Dietary Supplement
Intervention Name(s)
Adjunctive use of lavender and peppermint essential oils
Other Intervention Name(s)
aromatherapy
Intervention Description
passive inhalation aromatherapy following joint surgery
Primary Outcome Measure Information:
Title
discomfort, anxiety, or GI distress
Description
visual analog sale
Time Frame
total of 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise m Kresevic, PhD
Phone
216 844 1000
Ext
41909
Email
denise.kresevic@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Kresevic, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Kresevic, PhD
Phone
216-844-1000
Ext
41909
Email
Denise.Kresevic@UHhospitals.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
hope to publish results

Learn more about this trial

The Adjunctive Use of Lavender and Peppermint Essential Oils

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