Expired Study
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Columbus, Ohio 43210


Purpose:

The purpose of this study is to examine the body's response to relaxing and stimulating fragrances commonly used in aromatherapy.


Study summary:

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.


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


Study is Available At:


Original ID:

R21 AT002122-01


NCT ID:

NCT00097253


Secondary ID:


Study Acronym:


Brief Title:

The Effects of Smell on Mood and Physical Responses


Official Title:

Psychoneuroimmunology and Mind-Body Medicine: Olfaction, Mood, and Physiological Responses


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

44 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

56


Enrollment Type:

Actual


Overall Contact Information

Official Name:Janice Kiecolt-Glaser, PhD
Principal Investigator
Ohio State University Institute for Biobehavioral Medicine Research

Study Dates

Start Date:August 2005
Completion Date:March 2006
Completion Type:Actual
Primary Completion Date:March 2006
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:February 12, 2010
First Received Date:November 19, 2004
First Results Date:April 23, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure: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.
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Immune Function
Time Frame:3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Exposure to relaxant and stimulant odors
Description: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.
Arm Name:Lavender
Other Name:Citrus: lemon.

Study Arms

Study Arm Type:Experimental
Arm Name:Lavender
Study Arm Type:Experimental
Arm Name:Citrus
Study Arm Type:Placebo Comparator
Arm Name:Water

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Kiecolt-Glaser JK, Graham JE, Malarkey WB, Porter K, Lemeshow S, Glaser R. Olfactory influences on mood and autonomic, endocrine, and immune function. Psychoneuroendocrinology. 2008 Apr;33(3):328-39.
PMID:18178322

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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