Effects of Stress-reducing Aromatherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01307748
First received: March 2, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Stress-related Problems
Other: aroma
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Salivary cortisol change [ Time Frame: assessed at baseline, challenge tasks, post-challenge ] [ Designated as safety issue: No ]
    Change in salivary cortisol

  • EEG frontal lateral asymmetry change [ Time Frame: at baseline, challenge tasks, post-challenge ] [ Designated as safety issue: No ]
    Change in frontal lateral asymmetry


Secondary Outcome Measures:
  • Cognitive performance change [ Time Frame: at baseline and post-challenge ] [ Designated as safety issue: No ]
    change in cognitive performance


Enrollment: 92
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Barry S. Oken, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01307748     History of Changes
Other Study ID Numbers: IRB#00006890
Study First Received: March 2, 2011
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
aromatherapy
stress
older adults
stress-related change

ClinicalTrials.gov processed this record on April 17, 2014