Back to resultsA Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavandula Angustifolia oil (LO)
Michelia Alba Leaf oil (MA)
Almond oil (AO)
Water
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring Preoperative Anxiety, Breast Surgery, Lavender Aromatherapy
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Lavandula Angustifolia oil (LO)
Michelia Alba Leaf oil (MA)
Almond oil (AO)
Water
Arm Description
2 Drops in Oxygen Mask
2 Drops in Oxygen Mask
2 Drops in Oxygen Mask
2 Drops in Oxygen Mask
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03445130
Brief Title
A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
Official Title
A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Preoperative Anxiety, Breast Surgery, Lavender Aromatherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavandula Angustifolia oil (LO)
Arm Type
Active Comparator
Arm Description
2 Drops in Oxygen Mask
Arm Title
Michelia Alba Leaf oil (MA)
Arm Type
Active Comparator
Arm Description
2 Drops in Oxygen Mask
Arm Title
Almond oil (AO)
Arm Type
Active Comparator
Arm Description
2 Drops in Oxygen Mask
Arm Title
Water
Arm Type
Active Comparator
Arm Description
2 Drops in Oxygen Mask
Intervention Type
Other
Intervention Name(s)
Lavandula Angustifolia oil (LO)
Intervention Description
two drops on the inside of an oxygen face mask for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Michelia Alba Leaf oil (MA)
Intervention Description
two drops on the inside of an oxygen face mask for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Almond oil (AO)
Intervention Description
two drops on the inside of an oxygen face mask for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
two drops on the inside of an oxygen face mask for 15 minutes.
Primary Outcome Measure Information:
Title
Reduction in anxiety as measured by the change in baseline STAI scores
Description
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.
Time Frame
20 Minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women undergoing breast surgery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wajda, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Requests should be directed to Lola.Franco@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
We'll reach out to this number within 24 hrs