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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Other: Lavandula Angustifolia oil (LO)
* Other: Michelia Alba Leaf oil (MA)
* Other: Almond oil (AO)
* Other: Water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Anxiety, Breast Surgery, Lavender Aromatherapy