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

Primary Purpose

Anxiety; Generalized, Breast Diseases, Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender oil
Placebo
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety; Generalized focused on measuring re-operative anxiety, breast surgery, lavender oil, aromatherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lavender oil

Placebo

Arm Description

Lavender oil aromatherapy

Placebo -- unscented oil aromatherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2013
Last Updated
January 19, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT01837966
Brief Title
Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients
Official Title
A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety; Generalized, Breast Diseases, Surgery
Keywords
re-operative anxiety, breast surgery, lavender oil, aromatherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender oil
Arm Type
Active Comparator
Arm Description
Lavender oil aromatherapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo -- unscented oil aromatherapy
Intervention Type
Other
Intervention Name(s)
Lavender oil
Intervention Description
2 drops for aromatherapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 drops unscented mineral oil for aromatherapy
Primary Outcome Measure Information:
Title
Anxiety Reduction
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wajda, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22084330
Citation
Kil HK, Kim WO, Chung WY, Kim GH, Seo H, Hong JY. Preoperative anxiety and pain sensitivity are independent predictors of propofol and sevoflurane requirements in general anaesthesia. Br J Anaesth. 2012 Jan;108(1):119-25. doi: 10.1093/bja/aer305. Epub 2011 Nov 13.
Results Reference
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PubMed Identifier
1096279
Citation
Nelson JP, Glassburn AR Jr, Talbott RD, McElhinney JP. Horizontal flow clean room. Bacteriologic studies. Rocky Mt Med J. 1975 Jun;72(6):243-6. No abstract available.
Results Reference
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PubMed Identifier
12690999
Citation
Moss M, Cook J, Wesnes K, Duckett P. Aromas of rosemary and lavender essential oils differentially affect cognition and mood in healthy adults. Int J Neurosci. 2003 Jan;113(1):15-38. doi: 10.1080/00207450390161903.
Results Reference
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PubMed Identifier
15519366
Citation
Barocelli E, Calcina F, Chiavarini M, Impicciatore M, Bruni R, Bianchi A, Ballabeni V. Antinociceptive and gastroprotective effects of inhaled and orally administered Lavandula hybrida Reverchon "Grosso" essential oil. Life Sci. 2004 Nov 26;76(2):213-23. doi: 10.1016/j.lfs.2004.08.008.
Results Reference
background
PubMed Identifier
21854199
Citation
Kim S, Kim HJ, Yeo JS, Hong SJ, Lee JM, Jeon Y. The effect of lavender oil on stress, bispectral index values, and needle insertion pain in volunteers. J Altern Complement Med. 2011 Sep;17(9):823-6. doi: 10.1089/acm.2010.0644. Epub 2011 Aug 19.
Results Reference
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PubMed Identifier
22964265
Citation
Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, Goshen-Gottstein Y, Eidelman LA. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. Br J Anaesth. 2012 Dec;109(6):943-9. doi: 10.1093/bja/aes313. Epub 2012 Sep 10.
Results Reference
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PubMed Identifier
22752014
Citation
Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.
Results Reference
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Randomized, Placebo-Controlled Study: Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Patients

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