Overview

This trial is active, not recruiting.

Conditions anxiety; generalized, breast diseases, surgery
Treatments lavender oil, placebo
Sponsor New York University School of Medicine
Start date January 2013
End date September 2013
Trial size 90 participants
Trial identifier NCT01837966, 12-03152

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Lavender oil aromatherapy
lavender oil
2 drops for aromatherapy
(Placebo Comparator)
Placebo -- unscented oil aromatherapy
placebo
2 drops unscented mineral oil for aromatherapy

Primary Outcomes

Measure
Anxiety reduction
time frame: 20 minutes before surgery

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by New York University School of Medicine.