Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    linalool
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445130
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Other: Lavandula Angustifolia oil (LO) Other: Michelia Alba Leaf oil (MA) Other: Almond oil (AO) Other: Water Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 10, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Reduction in anxiety as measured by the change in baseline STAI scores [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing breast surgery
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445130


Contacts
Layout table for location contacts
Contact: Lola Franco, MD 212 263 0531 lola.franco@nyulangone.org

Locations
Layout table for location information
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Lola Franco    212-263-0531    Lola.Franco@nyulangone.org   
Principal Investigator: Michael Wajda, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Michael Wajda, MD New York Langone Medical Center

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03445130     History of Changes
Other Study ID Numbers: 16-01844
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Requests should be directed to Lola.Franco@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Layout table for additional information
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:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders