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Effects of Stress-reducing Aromatherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01307748
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University

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

Condition or disease Intervention/treatment Phase
Stress-related Problems Other: aroma Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: stress reducing aroma
aroma with reported stress reducing effects
Other: aroma
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
  • lavandula angustifolia
  • cocos nucifera
  • aqua destillata

Placebo Comparator: Placebo aroma 1 Other: aroma
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
  • lavandula angustifolia
  • cocos nucifera
  • aqua destillata

Placebo Comparator: Placebo aroma 2 Other: aroma
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
  • lavandula angustifolia
  • cocos nucifera
  • aqua destillata




Primary Outcome Measures :
  1. 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) ]
    Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)


Secondary Outcome Measures :
  1. 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.

  2. 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) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307748


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Barry S Oken, MD Oregon Health and Science University
Publications of Results:
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Responsible Party: Barry S. Oken, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01307748    
Other Study ID Numbers: IRB#00006890
First Posted: March 3, 2011    Key Record Dates
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019
Last Verified: July 2019
Keywords provided by Barry S. Oken, Oregon Health and Science University:
aromatherapy
stress
older adults
stress-related change