Effects of Stress-reducing Aromatherapy

Phase 2

Completed

• Conditions: Stress-related Problems
• Interventions: Other: aroma

• Registration Number: NCT01307748
• Lead Sponsor: Oregon Health and Science University

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2018-12-28
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-15
• Last Update Submitted: 2019-07-15
• Results First Posted: 2019-08-19
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stress reducing aroma	aroma	aroma with reported stress reducing effects
Placebo aroma 1	aroma	-
Placebo aroma 2	aroma	-

Primary Outcome Measures

Name	Time	Method
Percent of Baseline Level of Salivary Cortisol	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 Outcome Measures

Name	Time	Method
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)	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.
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)	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States