The Adjunctive Use of Lavender and Peppermint Essential Oils | NCT04934969

Studies
The Adjunctive Use of Lavender and Peppermint Essential Oils

NCT04934969

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

Apr 11, 2024Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Joint Diseases

Interventions

Adjunctive use of lavender and peppermint essential oils

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2021Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2024

Last Update Posted Date

Apr 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Denise Kresevic, clinical nurse specialist, University Hospitals Cleveland Medical CenterPrincipal Investigator

Lead Sponsor

University Hospitals Cleveland Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use of lavender and peppermint essential oils pre and post	Experimental	passive inhalation of either peppermint and lavender essential oil with pre and post test measure	Dietary Supplement: Adjunctive use of lavender and peppermint essential oils

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adjunctive use of lavender and peppermint essential oils	Dietary Supplement	passive inhalation aromatherapy following joint surgery	Use of lavender and peppermint essential oils pre and post

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
discomfort, anxiety, or GI distress	visual analog sale	total of 90 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denise Kresevic, PhD	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

hope to publish results

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007592	Joint Diseases

ID	Term
D009140	Musculoskeletal Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D019341	Aromatherapy

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D008517	Phytotherapy

Browse Leaves

Not provided

Browse Branches

Not provided