- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307748
Effects of Stress-reducing Aromatherapy
July 15, 2019 updated by: Barry S. Oken, Oregon Health and Science University
Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.
Study Overview
Detailed Description
The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works by comparing participants' physiologic responses to laboratory challenge tasks with and without experiencing aromatherapy.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- in good physical and cognitive health
- reporting moderate level of stress
- able to perceive aromas
- able to understand and follow study instructions
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: stress reducing aroma
aroma with reported stress reducing effects
|
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
|
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Placebo Comparator: Placebo aroma 1
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Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
|
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Placebo Comparator: Placebo aroma 2
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Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Baseline Level of Salivary Cortisol
Time Frame: 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)
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electroencephalography (EEG) Frontal Asymmetry
Time Frame: 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)
|
EEG frontal asymmetry (FA) is used to assess emotional state.
EEG FA processing was completed by averaging local reference EEG filtered offline from 0.1 to 70 Hz (with 60 Hz notch filter).
5-min data periods during each time were segmented into 2 seconds epochs, and the semi-automatic artifact rejection was applied.
The remaining artifact-free epochs were subjected to Fast Fourier Transform (FFT) .
The power spectra for individual epochs were averaged, and the measures of EEG spectral density were obtained for alpha band (8 -12.99 Hz).
Square root values of power were used, and frontal hemispheric asymmetry was calculated as ((L-R)/(L+R))*100, where L and R are square root values at the homologous left and right hemisphere sites (using local average reference values at F3 and F4).
With this calculation, FA negative values reflect lower alpha power (higher activation) in the left hemisphere linked to a more positive mood.
This is a unit-free measure.
|
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)
|
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Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score
Time Frame: Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)
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Percent change from baseline in cognitive performance score on the Digit Span Backward (DSB) task.
DSB scores range from 0 to 16, with greater scores indicative of better cognitive function.
Positive change from baseline indicates better functioning.
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Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barry S Oken, MD, Oregon Health and Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 2, 2011
First Posted (Estimate)
March 3, 2011
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
July 15, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB#00006890
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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