Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Michael Wajda, New York University School of Medicine
ClinicalTrials.gov Identifier:
First received: April 18, 2013
Last updated: April 23, 2015
Last verified: April 2015
The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.

Condition Intervention
Anxiety; Generalized
Breast Diseases
Other: Lavender oil
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients

Resource links provided by NLM:

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Anxiety Reduction [ Time Frame: 20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy) ] [ Designated as safety issue: No ]
    We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.

Enrollment: 93
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lavender oil
Lavender oil aromatherapy
Other: Lavender oil
2 drops for aromatherapy
Placebo Comparator: Placebo
Placebo -- unscented oil aromatherapy
Other: Placebo
2 drops unscented mineral oil for aromatherapy

Detailed Description:

Many patients undergoing surgery experience anxiety in the preoperative setting. Pharmacologic anxiolytics require monitoring and cause excess sedation which often interferes with the ability to assess and obtain consent from a patient in the preoperative holding area. Lavender aromatherapy is an alternative treatment for anxiety which is safe, inexpensive, easy to administer, and not overly sedating. In addition to its benefits in the preoperative setting, anxiolysis and reduction in sympathetic drive can lead to reduction in the intraoperative anesthetic and postoperative analgesic requirements. This in turn can lead to faster recovery and expedited discharge from the post anesthesia care unit.

In the proposed study, we would evaluate the efficacy of aromatherapy with lavender oil in reducing anxiety prior to breast surgery. The study group would receive lavender oil preoperatively and the placebo group would receive unscented oil preoperatively. Before and after treatment, anxiety level would be measured using the Spielberger State-Trait Anxiety Inventory. Additionally, vital signs and Bispectral index (BIS) will be measured before and after treatment, as further indicators of anxiety level. We hypothesize that lavender aromatherapy will decrease anxiety and subsequently will reduce blood pressure, heart rate, and BIS.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria: Female; Age 18+; American Society of Anesthesiologists (ASA) I-III; undergoing elective breast surgery

Exclusion Criteria: Male; History of asthma/bronchitis/Chronic Obstructive Pulmonary Disease (COPD)/contact dermatitis to cosmetic fragrances/pregnancy; significant laboratory abnormalities.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837966

United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Study Director: Michael Wajda, MD NYU School of Medicine
  More Information


Responsible Party: Michael Wajda, Associate Professor; Vice Chair for Education; Residency Program Director, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01837966     History of Changes
Other Study ID Numbers: 12-03152
Study First Received: April 18, 2013
Results First Received: December 22, 2014
Last Updated: April 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
re-operative anxiety
breast surgery
lavender oil

Additional relevant MeSH terms:
Anxiety Disorders
Breast Diseases
Mental Disorders
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2015