Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients
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| ClinicalTrials.gov Identifier: NCT01837966 |
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Recruitment Status :
Completed
First Posted : April 23, 2013
Results First Posted : May 12, 2015
Last Update Posted : March 3, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety; Generalized Breast Diseases Surgery | Other: Lavender oil Other: Placebo | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 93 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | January 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Lavender oil
Lavender oil aromatherapy
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Other: Lavender oil
2 drops for aromatherapy |
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Placebo Comparator: Placebo
Placebo -- unscented oil aromatherapy
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Other: Placebo
2 drops unscented mineral oil for aromatherapy |
- Anxiety Reduction [ Time Frame: 20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Female; Age 18+; American Society of Anesthesiologists (ASA) I-III; undergoing elective breast surgery
Exclusion Criteria: Male; History of asthma/bronchitis/Chronic Obstructive Pulmonary Disease (COPD)/contact dermatitis to cosmetic fragrances/pregnancy; significant laboratory abnormalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | NYU Langone Health |
| ClinicalTrials.gov Identifier: | NCT01837966 |
| Other Study ID Numbers: |
12-03152 |
| First Posted: | April 23, 2013 Key Record Dates |
| Results First Posted: | May 12, 2015 |
| Last Update Posted: | March 3, 2017 |
| Last Verified: | January 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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re-operative anxiety breast surgery lavender oil aromatherapy |
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Breast Diseases Anxiety Disorders Mental Disorders Skin Diseases |