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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Michelia Alba Leaf oil (MA); Other: Almond oil (AO); Other: Lavandula Angustifolia oil (LO); Other: Water

• Registration Number: NCT03445130
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-02-26
• Study Start: 2019-04-10
• Primary Completion: 2020-09-23
• Study Completion: 2020-09-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Michelia Alba Leaf oil (MA)	Michelia Alba Leaf oil (MA)	2 Drops in Oxygen Mask
Almond oil (AO)	Almond oil (AO)	2 Drops in Oxygen Mask
Lavandula Angustifolia oil (LO)	Lavandula Angustifolia oil (LO)	2 Drops in Oxygen Mask
Water	Water	2 Drops in Oxygen Mask

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States