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CompletedNCT01307748Updated Aug 19, 2019Results posted

Effects of Stress-reducing Aromatherapy

A Phase 2/3 interventional study of aroma in Stress-related Problems, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by Oregon Health and Science University · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Stress-related Problems

Keywords

  • aromatherapy
  • stress
  • older adults
  • stress-related change
03

In context

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    stress reducing aroma

    aroma with reported stress reducing effects

    Other: aroma

  • Placebo comparator
    Placebo aroma 1

    Other: aroma

  • Placebo comparator
    Placebo aroma 2

    Other: aroma

Interventions

  • Otheraroma

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

    Also known as: lavandula angustifolia, cocos nucifera, aqua destillata

06

What researchers measure

Primary outcomes

  1. Percent of Baseline Level of Salivary Cortisol

    Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)

    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)

Secondary outcomes

  1. 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.

    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)

  2. 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.

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

07

Results

Posted Aug 19, 2019
Limitations and caveats
Sample included well-educated people over 50 interested in aromatherapy (mostly female). The essential oil and placebo aromas preparations were study-specific.The results are most relevant to the doses and preparations of the aroma stimuli we used.

Participant flow

212 people potentially interested in the study were evaluated for eligibility between 2010 and 2012. The potential participants were referred by clinicians from the university sleep clinic or learned about the study from the IRB-approved study information posted around the university, or published on social media.

Participant flow — Overall Study
MilestoneDetectable Placebo Aroma: CoconutStress Reducing Aroma: LavenderUndetectable Placebo Aroma: Water
Started313130
Completed313130
Not completed000

Outcome measures

PrimaryPercent of Baseline Level of Salivary Cortisol

Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)

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)
Reported as:
Mean · percentage of baseline cortisol level
Percent of Baseline Level of Salivary Cortisol
percentage of baseline cortisol levelStress Reducing Aroma:LavenderDetectable Placebo Aroma: CoconutUndetectable Placebo Aroma: Water
stress battery170.8 ± 31.3224.7 ± 30.8274.7 ± 31.9
post-stress106.4 ± 70.6187.3 ± 69.5131.2 ± 71.9
Statistical analysis
  • Stress Reducing Aroma:Lavender vs Detectable Placebo Aroma: Coconut vs Undetectable Placebo Aroma: Water · ANCOVA · p = .005 (The p value was adjusted for multiple comparisons using false discovery rate.)Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.
SecondaryElectroencephalography (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.

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)
Reported as:
Mean · unitless
Electroencephalography (EEG) Frontal Asymmetry
unitlessStress Reducing Aroma: LavenderDetectable Placebo Aroma: CoconutUndetectable Placebo Aroma: Water
Baseline.013 ± .027.006 ± .026.036 ± .028
Aromatherapy exposure onset.005 ± .028-.014 ± .027.064 ± .029
Stress battery.031 ± .027-.001 ± .026.066 ± .029
Post-stress.009 ± .026.037 ± .025.089 ± .027
SecondaryCognitive 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.

Time frame:
Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)
Reported as:
Mean · Percent change from baseline in DSB task
Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score
Percent change from baseline in DSB taskStress Reducing Aroma: LavenderDetectable Placebo Aroma: CoconutUndetectable Placebo Aroma: Water
Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score15.24 ± 4.09-.37 ± 4.090.92 ± 4.15
Statistical analysis
  • Stress Reducing Aroma: Lavender vs Detectable Placebo Aroma: Coconut vs Undetectable Placebo Aroma: Water · ANCOVA · p = .01 (P value was adjusted for multiple comparisons using false discovery rate)A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.

Adverse events

Collected over The subjects actively participated in the study during one visit, approximately 4 hours in length. The adverse event data were collected for each subject during and immediately after their active study participation. The subjects were encouraged to call if they experienced any adverse events they thought might be related to the study. The overall study period of active enrollment and participation lasted between years 2010 and 2012.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stress Reducing Aroma: Lavender0/31 (0%)0/31 (0%)1/31 (3.2%)
Detectablle Placebo Aroma: Coconut0/31 (0%)0/31 (0%)0/31 (0%)
Undetectalbe Placebo Aroma: Water0/30 (0%)0/30 (0%)0/30 (0%)
Most frequent other events
Most frequent other events
EventStress Reducing Aroma: LavenderDetectablle Placebo Aroma: CoconutUndetectalbe Placebo Aroma: Water
Headache after study participationProduct Issues1/310/310/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Stress Reducing AromaPlacebo Aroma 1Placebo Aroma 2Total
Mean58.9 ± 6.657.9 ± 6.057.3 ± 5.958.0 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)Stress Reducing AromaPlacebo Aroma 1Placebo Aroma 2Total
Female24262373
Male75719
Region of Enrollment
Region of Enrollment(participants)Stress Reducing AromaPlacebo Aroma 1Placebo Aroma 2Total
United States31313192
08

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
09

References and documents

Publications

  • Chamine I, Oken BS. Aroma Effects on Physiologic and Cognitive Function Following Acute Stress: A Mechanism Investigation. J Altern Complement Med. 2016 Sep;22(9):713-21. doi: 10.1089/acm.2015.0349. Epub 2016 Jun 29. PubMed 27355279 ↗
  • Chamine I, Oken BS. Expectancy of stress-reducing aromatherapy effect and performance on a stress-sensitive cognitive task. Evid Based Complement Alternat Med. 2015;2015:419812. doi: 10.1155/2015/419812. Epub 2015 Jan 31. PubMed 25802539 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01307748
Lead sponsor
Oregon Health and Science University
Responsible party
Barry S. Oken (Professor, Oregon Health and Science University) — Principal investigator
First posted
Mar 3, 2011
Start date
Dec 2010
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Aug 19, 2019
Last update
Aug 19, 2019

Study contacts

Barry S Oken, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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