NCT01837966

Brief Summary

The study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

April 18, 2013

Results QC Date

December 22, 2014

Last Update Submit

January 19, 2017

Conditions

Anxiety; GeneralizedBreast DiseasesSurgery

Keywords

re-operative anxietybreast surgerylavender oilaromatherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)

Study Arms (2)

Lavender oil

ACTIVE COMPARATOR

Lavender oil aromatherapy

Other: Lavender oil

Placebo

PLACEBO COMPARATOR

Placebo -- unscented oil aromatherapy

Other: Placebo

Interventions

Lavender oilOTHER

2 drops for aromatherapy

Lavender oil
PlaceboOTHER

2 drops unscented mineral oil for aromatherapy

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (7)

  • 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.

    PMID: 22084330BACKGROUND

  • 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.

    PMID: 1096279BACKGROUND

  • 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.

    PMID: 12690999BACKGROUND

  • 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.

    PMID: 15519366BACKGROUND

  • 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.

    PMID: 21854199BACKGROUND

  • 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.

    PMID: 22964265BACKGROUND

  • 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.

    PMID: 22752014BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderBreast Diseases

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Associate Professor ; Res Program Dir/Medical Dir Day Surgery; Vice Chair for Education
Organization
NYU School of Medicine
michael.wajda@nyumc.org
212.263.5072

Study Officials

  • Michael Wajda, MD

    NYU School of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 23, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

March 3, 2017

Results First Posted

May 12, 2015

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)