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Trial record 25 of 73 for:    aromatherapy

Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients

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ClinicalTrials.gov Identifier: NCT01837966
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : May 12, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anxiety; Generalized
Breast Diseases
Surgery
Interventions Other: Lavender oil
Other: Placebo
Enrollment 93
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.
Arm/Group Title Lavender Oil Placebo
Hide Arm/Group Description

Lavender oil aromatherapy

Lavender oil: 2 drops for aromatherapy

Placebo -- unscented oil aromatherapy

Placebo: 2 drops unscented mineral oil for aromatherapy

Period Title: Overall Study
Started 47 46
Completed 45 45
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Lavender Oil Placebo Total
Hide Arm/Group Description

Lavender oil aromatherapy

Lavender oil: 2 drops for aromatherapy

Placebo - unscented oil aromatherapy

Placebo: 2 drops unscented mineral oil for aromatherapy

Total of all reporting groups
Overall Number of Baseline Participants 43 45 88
Hide Baseline Analysis Population Description
93 patients were enrolled into the study, but only 88 had useable data. 43 patients in the lavender arm and 45 in the placebo/unscented oil arm had usable data.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants 45 participants 88 participants
50
(24 to 86)
48
(22 to 82)
49
(22 to 86)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
Male 0 0 0
Female 43 45 88
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.7%
6
  13.3%
8
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  14.0%
4
   8.9%
10
  11.4%
White
28
  65.1%
29
  64.4%
57
  64.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
  16.3%
6
  13.3%
13
  14.8%
American Society of Anesthesiologists (ASA) Physical Status Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 45 participants 88 participants
ASA I 15 15 30
ASA II 27 29 56
ASA III 1 1 2
[1]
Measure Description:

ASA Physical Status I, II, III

ASA I: Normal healthy patient (excludes the very young/very old) ASA II - Patients w/ mild systemic disease (No functional limitations; well-controlled disease of one body system; i.e. controlled HTN or diabetes w/o systemic effects, cigarette smoking w/o COPD) ASA III - Patients w/ severe systemic disease (Some functional limitation; controlled disease of more than one body system/or one major system; no immediate danger of death; i.e controlled Congestive Heart Failure, stable angina, old heart attack, poorly controlled HTN)

1.Primary Outcome
Title Anxiety Reduction
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of STAI-TRAIT questions
Arm/Group Title Lavender Oil Placebo
Hide Arm/Group Description:

Lavender oil aromatherapy

Lavender oil: 2 drops for aromatherapy

There were no adverse events for this arm.

Placebo -- unscented oil aromatherapy

Placebo: 2 drops unscented mineral oil for aromatherapy

There were no adverse events for this arm.

Overall Number of Participants Analyzed 43 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.89  (.32) .74  (.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lavender Oil Placebo
Hide Arm/Group Description

Lavender oil aromatherapy

Lavender oil: 2 drops for aromatherapy

There were no adverse events for this arm.

Placebo -- unscented oil aromatherapy

Placebo: 2 drops unscented mineral oil for aromatherapy

There were no adverse events for this arm.

All-Cause Mortality
Lavender Oil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lavender Oil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lavender Oil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/45 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Associate Professor ; Res Program Dir/Medical Dir Day Surgery; Vice Chair for Education
Organization: NYU School of Medicine
Phone: 212.263.5072
Publications:
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01837966     History of Changes
Other Study ID Numbers: 12-03152
First Submitted: April 18, 2013
First Posted: April 23, 2013
Results First Submitted: December 22, 2014
Results First Posted: May 12, 2015
Last Update Posted: March 3, 2017