Effects of Stress-reducing Aromatherapy

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

Detailed Description
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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.

Official Title
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Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults

Conditions
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Stress-related Problems

Intervention / Treatment
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* Other: aroma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stress reducing aroma<br>aroma with reported stress reducing effects | Other: aroma<br>* Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects<br>* Other names: aqua destillata;|
| Placebo Comparator: Placebo aroma 1<br> | Other: aroma<br>* Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects<br>* Other names: aqua destillata;|
| Placebo Comparator: Placebo aroma 2<br> | Other: aroma<br>* Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects<br>* Other names: aqua destillata;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Baseline Level of Salivary Cortisol | Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress) | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electroencephalography (EEG) Frontal Asymmetry | 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. | 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) | 
| Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score | 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. | Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress, aromatherapy, older adults, stress-related change