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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014