The Effects of Smell on Mood and Physical Responses
This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00097253
First received: November 19, 2004
Last updated: February 12, 2010
Last verified: February 2010
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Purpose
The purpose of this study is to examine the body's response to relaxing and stimulating fragrances commonly used in aromatherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Anxiety Depression |
Behavioral: Exposure to relaxant and stimulant odors |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Psychoneuroimmunology and Mind-Body Medicine: Olfaction, Mood, and Physiological Responses |
Resource links provided by NLM:
Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):
Primary Outcome Measures:
- Cortisol and Catecholamine Production [ Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15 ] [ Designated as safety issue: No ]
- Immune Function [ Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45 ] [ Designated as safety issue: No ]
- Skin Barrier Repair [ Time Frame: 3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15 ] [ Designated as safety issue: No ]
- Immune Function: Delayed Hypersensitivity to Candida(DTH) [ Time Frame: Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45. ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | August 2005 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lavender |
Behavioral: Exposure to relaxant and stimulant odors
A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
Other Name: Citrus: lemon.
|
| Experimental: Citrus |
Behavioral: Exposure to relaxant and stimulant odors
A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
Other Name: Citrus: lemon.
|
| Placebo Comparator: Water |
Behavioral: Exposure to relaxant and stimulant odors
A yellow-tinted cotton ball containing 100 ml of the essential oil or distilled water was taped between the nose and upper lip on top of a piece of surgical tape; use of the barrier tape avoided percutaneous absorption . This method provided continuous and uniform exposure across subjects that would not have been possible with ambient room inhalation, and helped maintain experimenter blindness.
Other Name: Citrus: lemon.
|
Detailed Description:
Despite aromatherapy's popularity, efficacy data are scant, and potential mechanisms are controversial. This randomized controlled trial examined the psychological, autonomic, endocrine, and immune consequences of one purported relaxant odor (lavender), one stimulant odor (lemon), and a no-odor control (water), before and after a stressor (cold pressor); 56 healthy men and women were exposed to each of the odors during three separate visits. To assess the effects of expectancies, participants randomized to the "blind" condition were given no information about the odors they would smell; "primed" individuals were told what odors they would smell during the session, and what changes to expect. Experimenters were blind.
In each case we measured several different aspects of the cellular immune response, as well as skin barrier repair following tape stripping. This design allowed us to examine the ability of the odors to modulate endocrine and immune function, and health-relevant cutaneous responses.
Eligibility| Ages Eligible for Study: | 18 Years to 44 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adults with a normal sense of smell
Exclusion Criteria:
- Treatment with medication that has immunological or endocrinological consequences
- Chronic health problems that affect immune or endocrine systems
- Allergy to perfume or cosmetics
- Problems with sense of smell
- Respiratory problems
- Smoker
- Current active asthma
- Use of psychoactive drugs or mood-altering medication
- History of anxiety disorder, major depression, bipolar disorder, schizophrenia, or other psychotic disorders
- History of chest pain or ventricular fibrillation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097253
Locations
| United States, Ohio | |
| Ohio State University Institute for Biobehavioral Medicine Research | |
| Columbus, Ohio, United States, 43210 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Janice Kiecolt-Glaser, PhD | Ohio State University Institute for Biobehavioral Medicine Research |
More Information
Additional Information:
Publications:
| Responsible Party: | Janice K. Kiecolt-Glaser, PhD, The Ohio State University, Department of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00097253 History of Changes |
| Other Study ID Numbers: | R21 AT002122-01 |
| Study First Received: | November 19, 2004 |
| Results First Received: | April 23, 2009 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Aromatherapy Smell |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Mental Disorders Behavioral Symptoms Mood Disorders |
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013