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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

Tracking Information
First Submitted Date  ICMJE March 2, 2011
First Posted Date  ICMJE March 3, 2011
Results First Submitted Date  ICMJE December 28, 2018
Results First Posted Date  ICMJE August 19, 2019
Last Update Posted Date August 19, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
  • Salivary cortisol change [ Time Frame: assessed at baseline, challenge tasks, post-challenge ]
    Change in salivary cortisol
  • EEG frontal lateral asymmetry change [ Time Frame: at baseline, challenge tasks, post-challenge ]
    Change in frontal lateral asymmetry
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2011)
Cognitive performance change [ Time Frame: at baseline and post-challenge ]
change in cognitive performance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Stress-reducing Aromatherapy
Official Title  ICMJE Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
Brief Summary The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Stress-related Problems
Intervention  ICMJE Other: aroma
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
  • lavandula angustifolia
  • cocos nucifera
  • aqua destillata
Study Arms  ICMJE
  • Experimental: stress reducing aroma
    aroma with reported stress reducing effects
    Intervention: Other: aroma
  • Placebo Comparator: Placebo aroma 1
    Intervention: Other: aroma
  • Placebo Comparator: Placebo aroma 2
    Intervention: Other: aroma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2013)
92
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2011)
100
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307748
Other Study ID Numbers  ICMJE IRB#00006890
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barry S. Oken, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry S Oken, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP