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

NCT ID: NCT03445130

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2020-09-23

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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lavandula Angustifolia oil (LO)

2 Drops in Oxygen Mask

Group Type ACTIVE_COMPARATOR

Lavandula Angustifolia oil (LO)

Intervention Type OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Michelia Alba Leaf oil (MA)

2 Drops in Oxygen Mask

Group Type ACTIVE_COMPARATOR

Michelia Alba Leaf oil (MA)

Intervention Type OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Almond oil (AO)

2 Drops in Oxygen Mask

Group Type ACTIVE_COMPARATOR

Almond oil (AO)

Intervention Type OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Water

2 Drops in Oxygen Mask

Group Type ACTIVE_COMPARATOR

Water

Intervention Type OTHER

two drops on the inside of an oxygen face mask for 15 minutes.

Interventions

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Lavandula Angustifolia oil (LO)

two drops on the inside of an oxygen face mask for 15 minutes.

Intervention Type OTHER

Michelia Alba Leaf oil (MA)

two drops on the inside of an oxygen face mask for 15 minutes.

Intervention Type OTHER

Almond oil (AO)

two drops on the inside of an oxygen face mask for 15 minutes.

Intervention Type OTHER

Water

two drops on the inside of an oxygen face mask for 15 minutes.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Wajda, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-01844

Identifier Type: -

Identifier Source: org_study_id

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