Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients
The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.
Other: Lavender oil
|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|
- 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.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Lavender oil
Lavender oil aromatherapy
Other: Lavender oil
2 drops for aromatherapy
Placebo Comparator: Placebo
Placebo -- unscented oil aromatherapy
2 drops unscented mineral oil for aromatherapy
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.
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|
|Study Director:||Michael Wajda, MD||NYU School of Medicine|