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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445130
• Other study ID #: 16-01844
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: September 23, 2020

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Lavandula Angustifolia oil (LO)
two drops on the inside of an oxygen face mask for 15 minutes.
• Michelia Alba Leaf oil (MA)
two drops on the inside of an oxygen face mask for 15 minutes.
• Almond oil (AO)
two drops on the inside of an oxygen face mask for 15 minutes.
• Water
two drops on the inside of an oxygen face mask for 15 minutes.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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