Randomized Prospective Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preop Anxiety in Breast Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Wajda, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01837966
First received: April 18, 2013
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.


Condition Intervention
Anxiety; Generalized
Breast Diseases
Surgery
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 ] [ Designated as safety issue: No ]
    By monitoring vital signs, we hope to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast surgery. Tests are done before surgery. Tests are done, aromatherapy is given for 10 minutes, then tests are repeated.


Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated 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.

  Eligibility

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

Inclusion Criteria

  • Female
  • Age 18+
  • ASA I-III
  • undergoing elective breast surgery

Exclusion Criteria

  • Male
  • History of asthma/bronchitis/COPD/contact dermatitis to cosmetic fragrances/pregnancy
  • significant laboratory abnormalities.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01837966

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

Publications:

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
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014