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Effects of Stress-reducing Aromatherapy

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ClinicalTrials.gov Identifier: NCT01307748
Recruitment Status : Completed
First Posted : March 3, 2011
Last Update Posted : March 20, 2013
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.

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
Primary Completion Date : December 2012
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. Salivary cortisol change [ Time Frame: assessed at baseline, challenge tasks, post-challenge ]
    Change in salivary cortisol

  2. EEG frontal lateral asymmetry change [ Time Frame: at baseline, challenge tasks, post-challenge ]
    Change in frontal lateral asymmetry


Secondary Outcome Measures :
  1. Cognitive performance change [ Time Frame: at baseline and post-challenge ]
    change in cognitive performance



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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 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
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Barry S Oken, MD Oregon Health and Science University

Responsible Party: Barry S. Oken, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01307748     History of Changes
Other Study ID Numbers: IRB#00006890
First Posted: March 3, 2011    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Barry S. Oken, Oregon Health and Science University:
aromatherapy
stress
older adults
stress-related change