Effects of Stress-reducing Aromatherapy | Clinical Trial

Key information

Conditions

Stress-related Problems

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aroma

Other

Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects

Other names: lavandula angustifolia, cocos nucifera, aqua destillata

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

Electroencephalography (EEG) Frontal Asymmetry

Time frame: 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)

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.
Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score

Time frame: Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)

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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 3, 2011
Registry last updated: Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.