Trial Outcomes & Findings for Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients (NCT NCT01837966)
NCT ID: NCT01837966
Last Updated: 2017-03-03
Results Overview
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.
COMPLETED
NA
93 participants
20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)
2017-03-03
Participant Flow
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.
Only patients who had any allergy or sensitivity to the oils or had allergies were excluded.
Participant milestones
| Measure |
Lavender Oil
Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
|
Placebo
Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Lavender Oil
Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
|
Placebo
Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients
Baseline characteristics by cohort
| Measure |
Lavender Oil
n=43 Participants
Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
|
Placebo
n=45 Participants
Placebo - unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
48 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
43 participants
n=5 Participants
|
45 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification
ASA I
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification
ASA II
|
27 participants
n=5 Participants
|
29 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification
ASA III
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)Population: Analysis of STAI-TRAIT questions
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.
Outcome measures
| Measure |
Lavender Oil
n=43 Participants
Lavender oil aromatherapy
Lavender oil: 2 drops for aromatherapy
There were no adverse events for this arm.
|
Placebo
n=45 Participants
Placebo -- unscented oil aromatherapy
Placebo: 2 drops unscented mineral oil for aromatherapy
There were no adverse events for this arm.
|
|---|---|---|
|
Anxiety Reduction
|
0.89 units on a scale
Standard Deviation .32
|
.74 units on a scale
Standard Deviation .44
|
Adverse Events
Lavender Oil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Associate Professor ; Res Program Dir/Medical Dir Day Surgery; Vice Chair for Education
NYU School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place