Anxiety; Generalized, Breast Diseases, Surgery
Conditions
Keywords
re-operative anxiety, breast surgery, lavender oil, aromatherapy
Brief 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.
Interventions
OTHERLavender oil
2 drops for aromatherapy
OTHERPlacebo
2 drops unscented mineral oil for aromatherapy
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Reduction | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the out-patient surgical unit of New York University (NYU) Langone Medical Center from January 18 - June 11, 2013. Only female patients having breast surgery were approached.
Pre-assignment details
Only patients who had any allergy or sensitivity to the oils or had allergies were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Lavender Oil Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy | 43 |
| Placebo Placebo - unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy | 45 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Lavender Oil | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50 years | 48 years | 49 years |
| American Society of Anesthesiologists (ASA) Physical Status Classification ASA I | 15 participants | 15 participants | 30 participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification ASA II | 27 participants | 29 participants | 56 participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification ASA III | 1 participants | 1 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) White | 28 Participants | 29 Participants | 57 Participants |
| Sex/Gender, Customized Female | 43 participants | 45 participants | 88 participants |
| Sex/Gender, Customized Male | 0 participants | 0 participants | 0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 45 |
| serious Total, serious adverse events | 0 / 43 | 0 / 45 |
Outcome results
Primary
Anxiety Reduction
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.
Time frame: 20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)
Population: Analysis of STAI-TRAIT questions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender Oil | Anxiety Reduction | 0.89 units on a scale | Standard Deviation 0.32 |
| Placebo | Anxiety Reduction | .74 units on a scale | Standard Deviation 0.44 |