NCT04934969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration 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

June 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

June 15, 2021

Last Update Submit

April 9, 2024

Conditions

Joint Diseases

Outcome Measures

Primary Outcomes (1)

  • discomfort, anxiety, or GI distress

    visual analog sale

    total of 90 minutes

Study Arms (1)

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

Adjunctive use of lavender and peppermint essential oilsDIETARY_SUPPLEMENT

passive inhalation aromatherapy following joint surgery

Also known as: aromatherapy
Use of lavender and peppermint essential oils pre and post

Eligibility Criteria

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

You may qualify if:

  • \- elective joint replacement able to read and speak English and describe study procedures

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Joint Diseases

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Denise Kresevic, PhD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: feasibility of using essential oils post joint replacement surgery and trends toward relief of symptoms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical nurse specialist

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 22, 2021

Study Start

July 30, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

hope to publish results

Locations

US(1)