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Effects of Stress-reducing Aromatherapy

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ClinicalTrials.gov Identifier: NCT01307748
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Stress-related Problems
Intervention Other: aroma
Enrollment 92
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Detectable Placebo Aroma: Coconut Stress Reducing Aroma: Lavender Undetectable Placebo Aroma: Water
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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.

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.

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.
Period Title: Overall Study
Started 31 31 30
Completed 31 31 30
Not Completed 0 0 0
Arm/Group Title Stress Reducing Aroma Placebo Aroma 1 Placebo Aroma 2 Total
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aroma with reported stress reducing effects

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

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

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

Distilled water: substance with no odor or stress-reducing effects

Total of all reporting groups
Overall Number of Baseline Participants 31 31 30 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 30 participants 92 participants
58.9  (6.6) 57.9  (6.0) 57.3  (5.9) 58.0  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 30 participants 92 participants
Female 24 26 23 73
Male 7 5 7 19
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 31 participants 30 participants 92 participants
31 31 31 92
1.Primary Outcome
Title Percent of Baseline Level of Salivary Cortisol
Hide Description 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)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stress Reducing Aroma:Lavender Detectable Placebo Aroma: Coconut Undetectable Placebo Aroma: Water
Hide Arm/Group Description:
Lavender aroma with reported stress reducing effects
Coconut aroma with pleasant detectable smell but without known stress-reducing effects.
Distilled water: substance without smell or known stress-reducing effects
Overall Number of Participants Analyzed 31 31 30
Mean (Standard Error)
Unit of Measure: percentage of baseline cortisol level
stress battery 170.8  (31.3) 224.7  (30.8) 274.7  (31.9)
post-stress 106.4  (70.6) 187.3  (69.5) 131.2  (71.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stress Reducing Aroma:Lavender, Detectable Placebo Aroma: Coconut, Undetectable Placebo Aroma: Water
Comments The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments The p value was adjusted for multiple comparisons using false discovery rate.
Method ANCOVA
Comments Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.
2.Secondary Outcome
Title Electroencephalography (EEG) Frontal Asymmetry
Hide Description 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)
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Hide Analysis Population Description
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.
Arm/Group Title Stress Reducing Aroma: Lavender Detectable Placebo Aroma: Coconut Undetectable Placebo Aroma: Water
Hide Arm/Group Description:
Aroma with reported stress reducing effects
Coconut: aroma with detectable pleasant smell but without known stress-reducing effects
Distilled water: substance with no smell or known stress-reducing effects.
Overall Number of Participants Analyzed 27 27 27
Mean (Standard Error)
Unit of Measure: unitless
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)
3.Secondary Outcome
Title Cognitive Performance: Percent Change From Baseline in Digit Span Backward Task Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stress Reducing Aroma: Lavender Detectable Placebo Aroma: Coconut Undetectable Placebo Aroma: Water
Hide Arm/Group Description:
Aroma with reported stress reducing effects.
Coconut: aroma with detectable pleasant odor but no reported stress-reducing effects
Distilled water: substance with no odor or known stress-reducing effects.
Overall Number of Participants Analyzed 31 31 30
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline in DSB task
15.24  (4.09) -.37  (4.09) 0.92  (4.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stress Reducing Aroma: Lavender, Detectable Placebo Aroma: Coconut, Undetectable Placebo Aroma: Water
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments P value was adjusted for multiple comparisons using false discovery rate
Method ANCOVA
Comments A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stress Reducing Aroma: Lavender Detectablle Placebo Aroma: Coconut Undetectalbe Placebo Aroma: Water
Hide Arm/Group Description Aroma with reported stress reducing effects. Aroma with pleasant odor but no known stress-reducing effects Distilled water: substance with no odor or known stress-reducing effects
All-Cause Mortality
Stress Reducing Aroma: Lavender Detectablle Placebo Aroma: Coconut Undetectalbe Placebo Aroma: Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/31 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Stress Reducing Aroma: Lavender Detectablle Placebo Aroma: Coconut Undetectalbe Placebo Aroma: Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/31 (0.00%)      0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stress Reducing Aroma: Lavender Detectablle Placebo Aroma: Coconut Undetectalbe Placebo Aroma: Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      0/31 (0.00%)      0/30 (0.00%)    
Product Issues       
Headache after study participation * [1]  1/31 (3.23%)  1 0/31 (0.00%)  0 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Irina Chamine
Organization: Oregon Health & Science University
Phone: 503.577.6211
EMail: fonareva@ohsu.edu
Layout table for additonal information
Responsible Party: Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01307748    
Other Study ID Numbers: IRB#00006890
First Submitted: March 2, 2011
First Posted: March 3, 2011
Results First Submitted: December 28, 2018
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019