Clinical Trials Directory

Trials / Completed

CompletedNCT01837966

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

A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
93 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERLavender oil2 drops for aromatherapy
OTHERPlacebo2 drops unscented mineral oil for aromatherapy

Timeline

Start date
2013-01-01
Primary completion
2013-09-01
Completion
2014-01-01
First posted
2013-04-23
Last updated
2017-03-03
Results posted
2015-05-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01837966. Inclusion in this directory is not an endorsement.