Effects of Stress-reducing Aromatherapy
This study has been completed.
Sponsor:
Oregon Health and Science University
Information provided by (Responsible Party):
Barry S. Oken, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01307748
First received: March 2, 2011
Last updated: March 18, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | March 2, 2011 | ||||
| Last Updated Date | March 18, 2013 | ||||
| Start Date ICMJE | December 2010 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01307748 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cognitive performance change [ Time Frame: at baseline and post-challenge ] [ Designated as safety issue: No ] change in cognitive performance |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Stress-reducing Aromatherapy | ||||
| Official Title ICMJE | Physiologic and Expectancy Effects of Stress-reducing Aroma in Older Adults | ||||
| Brief Summary | The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Stress-related Problems | ||||
| Intervention ICMJE | Other: aroma
Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other Names:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 92 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01307748 | ||||
| Other Study ID Numbers ICMJE | IRB#00006890 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Barry S. Oken, Oregon Health and Science University | ||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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