Stress-related ProblemsPhase 2/3NCT01307748
Effects of Stress-reducing Aromatherapy
A Phase 2/3 study testing aroma in people with Stress-related Problems, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress-related Problems
- What is being tested?
- aroma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in good physical and cognitive health
- reporting moderate level of stress
- able to perceive aromas
- able to understand and follow study instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
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.
- Conditions
- Stress-related Problems
- Being tested
- aroma
- Keywords
- aromatherapy, stress, older adults, stress-related change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromaOther
Also called lavandula angustifolia, cocos nucifera, aqua destillata
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
| Study group | Role | What they receive |
|---|---|---|
| stress reducing aroma | Experimental | aroma with reported stress reducing effects Receives: Other: aroma |
| Placebo aroma 1 | Placebo comparator | Not described Receives: Other: aroma |
| Placebo aroma 2 | Placebo comparator | Not described Receives: Other: aroma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Baseline Level of Salivary Cortisol
Percent of baseline level of salivary cortisol (values greater than baseline indicate increased stress)
Measured: 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 (2)
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.
Measured: 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.
Measured: Baseline (60 min prior to aroma exposure and stress), post-stress (60 min after completing stress battery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress-related ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry S Oken, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307748
- Sponsor's protocol ID
- IRB#00006890
- Status last verified
- Jul 2019
- First submitted
- 2 Mar 2011
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 27355279Chamine 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults
- ClinicalTrials.gov ID
- NCT01307748
- Acronym / sponsor ID
- IRB#00006890
- Conditions
- Stress-related Problems
- Keywords
- aromatherapy, stress, older adults, stress-related change
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stress reducing aroma | Experimental | Other: aromaaroma with reported stress reducing effects |
| Placebo aroma 1 | Placebo comparator | Other: aroma |
| Placebo aroma 2 | Placebo comparator | Other: aroma |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- in good physical and cognitive health
- reporting moderate level of stress
- able to perceive aromas
- able to understand and follow study instructions
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromaAlso: lavandula angustifolia, cocos nucifera, aqua destillataComparison of known stress reducing aroma to placebo aromas without stress-reducing effects | Other | Placebo aroma 1, Placebo aroma 2, stress reducing aroma |
Primary outcome
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)
2 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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27355279Chamine 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.
- Results publication: PubMed 25802539Chamine 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Oken, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing aroma in people with Stress-related Problems, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307748, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.