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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03445130
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 4
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Lavandula Angustifolia oil (LO); Other: Michelia Alba Leaf oil (MA); Other: Almond oil (AO); Other: Water	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
• Actual Study Start Date: Apr 10, 2019
• Actual Primary Completion Date: Sep 23, 2020
• Actual Study Completion Date: Sep 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reduction in anxiety as measured by the change in baseline STAI scores [20 Minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Michael Wajda, MD, New York Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03445130
• Other Study ID Numbers: 16-01844
• First Posted: Feb 26, 2018
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: Preoperative Anxiety; Breast Surgery; Lavender Aromatherapy
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Feb 18, 2022