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The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stress reducing aroma | Experimental | aroma with reported stress reducing effects |
|
| Placebo aroma 1 | Placebo Comparator |
| |
| Placebo aroma 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aroma | Other | Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry S Oken, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27355279 | Result | 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. | |
| 25802539 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Detectable Placebo Aroma: Coconut | Detectable placebo aroma:organic virgin coconut (Cocos nucifera) base oil (The Ananda Apothecary, Boulder, CO) diluted in 15 ml of grapeseed carrier oil (Now Foods, Bloomingdale, IL) and mixed until solution appeared clear. During the visit, three drops of the aroma solution were placed on a 5 x 5 mm cotton pad. The pad was then fixed to a small piece of transparent odor free tape that was attached to the participant's nose so that the pad infused with the aroma came to the midpoint between the participant's nose and upper lip. The cotton pad remained attached until the end of testing portion of the visit, but the aroma was not replenished during the testing. |
| FG001 | Stress Reducing Aroma: Lavender | One drop (using a dropper) of organic lavender (Lavandula angustifolia) essential oil (Mountain Rose Herbs, Eugene, OR) was diluted in 15 ml of grapeseed carrier oil (Now Foods, Bloomingdale, IL). During the visit, three drops of the aroma solution were placed on a 5 x 5 mm cotton pad. The pad was then fixed to a small piece of transparent odor free tape that was attached to the participant's nose so that the pad infused with the aroma came to the midpoint between the participant's nose and upper lip. The cotton pad remained attached until the end of testing portion of the visit, but the aroma was not replenished during the testing. |
| FG002 | Undetectable Placebo Aroma: Water | For the undetectable placebo aroma, distilled water was used to provide the appearance of essential oil while emitting no odor and producing no effects typically attributed to aromatherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stress Reducing Aroma | aroma with reported stress reducing effects aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects |
| BG001 | Placebo Aroma 1 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Baseline Level of Salivary Cortisol | Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress) | Posted | Mean | Standard Error | percentage of baseline cortisol level | 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) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stress Reducing Aroma: Lavender | Aroma with reported stress reducing effects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache after study participation | Product Issues | Non-systematic Assessment | One participant reported mild headache after study participation that can be related to stress inherent in the study visit or could be due to reacting to aroma. The event resolved on its own after the end of the visit. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irina Chamine | Oregon Health & Science University | 503.577.6211 | fonareva@ohsu.edu |
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| ID | Term |
|---|---|
| D009812 | Odorants |
| ID | Term |
|---|---|
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
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| 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) |
aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects.
Coconut aroma with pleasant odor but no reported stress-reducing effects
| BG002 | Placebo Aroma 2 | aroma: Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects. Distilled water: substance with no odor or stress-reducing effects |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| OG002 | Undetectable Placebo Aroma: Water | Distilled water: substance without smell or known stress-reducing effects |
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| Secondary | 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. | All participants had EEG recordings during their visit. However, some EEG data were lost due to electrode malfunction or unusable due to presence of too much noise. The data loss was similar in all study groups. | Posted | Mean | Standard Error | unitless | 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) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percent change from baseline in DSB task | Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery) |
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| 0 |
| 31 |
| 0 |
| 31 |
| 1 |
| 31 |
| EG001 | Detectablle Placebo Aroma: Coconut | Aroma with pleasant odor but no known stress-reducing effects | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Undetectalbe Placebo Aroma: Water | Distilled water: substance with no odor or known stress-reducing effects | 0 | 30 | 0 | 30 | 0 | 30 |
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| Stress battery |
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| Post-stress |
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