NCT01307748

Brief Summary

The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2010

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

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

August 19, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

March 2, 2011

Results QC Date

December 28, 2018

Last Update Submit

July 15, 2019

Conditions

Stress-related Problems

Keywords

aromatherapystressolder adultsstress-related change

Outcome Measures

Primary Outcomes (1)

  • Percent of Baseline Level of Salivary Cortisol

    Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)

    assessed at baseline (60 min prior to aroma exposure and stress), stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)

Secondary Outcomes (2)

  • Electroencephalography (EEG) Frontal Asymmetry

    assessed at baseline (60 min prior to aroma exposure and stress), at the onset of aromatherapy exposure, stress battery (30 min after aroma exposure and during stress), post-stress (60 min after completing stress battery)

  • Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score

    Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)

Study Arms (3)

stress reducing aroma

EXPERIMENTAL

aroma with reported stress reducing effects

Other: aroma

Placebo aroma 1

PLACEBO COMPARATOR
Other: aroma

Placebo aroma 2

PLACEBO COMPARATOR
Other: aroma

Interventions

aromaOTHER

Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects

Also known as: lavandula angustifolia, cocos nucifera, aqua destillata
Placebo aroma 1Placebo aroma 2stress reducing aroma

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in good physical and cognitive health
  • reporting moderate level of stress
  • able to perceive aromas
  • able to understand and follow study instructions

You may not qualify if:

  • taking medications affecting central nervous system (CNS) function or physiologic measures (e.g. steroids or neuroleptics)
  • reporting smell sensitivities or allergies
  • smoking presently or in the past less than one year prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • Chamine I, Oken BS. Aroma Effects on Physiologic and Cognitive Function Following Acute Stress: A Mechanism Investigation. J Altern Complement Med. 2016 Sep;22(9):713-21. doi: 10.1089/acm.2015.0349. Epub 2016 Jun 29.

    PMID: 27355279RESULT

  • Chamine I, Oken BS. Expectancy of stress-reducing aromatherapy effect and performance on a stress-sensitive cognitive task. Evid Based Complement Alternat Med. 2015;2015:419812. doi: 10.1155/2015/419812. Epub 2015 Jan 31.

    PMID: 25802539RESULT

MeSH Terms

Interventions

Odorants

Intervention Hierarchy (Ancestors)

EnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Limitations and Caveats

Sample included well-educated people over 50 interested in aromatherapy (mostly female). The essential oil and placebo aromas preparations were study-specific.The results are most relevant to the doses and preparations of the aroma stimuli we used.

Results Point of Contact

Title
Irina Chamine
Organization
Oregon Health & Science University
fonareva@ohsu.edu
503.577.6211

Study Officials

  • Barry S Oken, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 3, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 19, 2019

Results First Posted

August 19, 2019

Record last verified: 2019-07

Locations

US(1)