A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients

A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Lavandula Angustifolia oil (LO); Other: Michelia Alba Leaf oil (MA); Other: Almond oil (AO); Other: Water

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lavandula Angustifolia oil (LO); 2 Drops in Oxygen Mask	Other: Lavandula Angustifolia oil (LO); two drops on the inside of an oxygen face mask for 15 minutes.
Active Comparator: Michelia Alba Leaf oil (MA); 2 Drops in Oxygen Mask	Other: Michelia Alba Leaf oil (MA); two drops on the inside of an oxygen face mask for 15 minutes.
Active Comparator: Almond oil (AO); 2 Drops in Oxygen Mask	Other: Almond oil (AO); two drops on the inside of an oxygen face mask for 15 minutes.
Active Comparator: Water; 2 Drops in Oxygen Mask	Other: Water; two drops on the inside of an oxygen face mask for 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael Wajda, MD, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): September 23, 2020
• Study Completion (Actual): September 23, 2020

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Preoperative Anxiety; Breast Surgery; Lavender Aromatherapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 16-01844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Requests should be directed to Lola.Franco@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No