Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Percent of Baseline Level of Salivary Cortisol
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
stress reducing aroma
aroma with reported stress reducing effects
Intervention: aroma (Other)
Placebo aroma 1
Intervention: aroma (Other)
Placebo aroma 2
Intervention: aroma (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score(Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery))
- Electroencephalography (EEG) Frontal Asymmetry(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))
Investigators
Barry S. Oken
Professor
Oregon Health and Science University