NCT03445130

Brief Summary

The purpose of this study is to determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study participants will then be randomized into one of four groups; either they will receive 2 drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA) or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face mask for 15 minutes. Linalool makes up \~30% of Lavandula Angustifolia oil and is believed to be its most active anti-anxiety component. Before and after treatment, anxiety level will be measured using the Spielberger State-Trait Anxiety Inventory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

February 20, 2018

Last Update Submit

February 2, 2022

Conditions

Anxiety

Keywords

Preoperative AnxietyBreast SurgeryLavender Aromatherapy

Outcome Measures

Primary Outcomes (1)

  • Reduction in anxiety as measured by the change in baseline STAI scores

    Spielberger State-Trait Anxiety Inventory (STAI) is a self-reported instrument. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. State anxiety can be defined as a transient momentary emotional status that results from situational stress.

    20 Minutes

Study Arms (4)

Lavandula Angustifolia oil (LO)

ACTIVE COMPARATOR

2 Drops in Oxygen Mask

Other: Lavandula Angustifolia oil (LO)

Michelia Alba Leaf oil (MA)

ACTIVE COMPARATOR

2 Drops in Oxygen Mask

Other: Michelia Alba Leaf oil (MA)

Almond oil (AO)

ACTIVE COMPARATOR

2 Drops in Oxygen Mask

Other: Almond oil (AO)

Water

ACTIVE COMPARATOR

2 Drops in Oxygen Mask

Other: Water

Interventions

Lavandula Angustifolia oil (LO)OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Lavandula Angustifolia oil (LO)
Michelia Alba Leaf oil (MA)OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Michelia Alba Leaf oil (MA)
Almond oil (AO)OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Almond oil (AO)
WaterOTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Water

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing breast surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women, older than 18, American Society of Anesthesiologists (ASA) classification I-III, undergoing elective breast surgery on Tisch 10th floor Day Surgery. Cancer patients are included.

You may not qualify if:

  • History of asthma, bronchitis, COPD, contact dermatitis to cosmetic fragrances, positive patch test, pregnancy, and significant laboratory abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

almond oilWater

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Michael Wajda, MD

    New York Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 26, 2018

Study Start

April 10, 2019

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Requests should be directed to Lola.Franco@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)