Randomized Prospective Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preop Anxiety in Breast Patients
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|
The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Lavender oil aromatherapy
Placebo -- unscented oil aromatherapy
time frame: 20 minutes before surgery
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.
|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.|
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