The Effects of Smell on Mood and Physical Responses

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097253
• Other study ID #: R21AT002122-01
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2004
• Last updated: February 12, 2010
• Start date: August 2005
• Est. completion date: March 2006

Study information

• Verified date: February 2010
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University Institute for Biobehavioral Medicine Research	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1016/j.psyneuen.2007.11.015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol and Catecholamine Production		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	No
Primary	Immune Function		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	No
Primary	Skin Barrier Repair		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	No
Primary	Immune Function: Delayed Hypersensitivity to Candida(DTH)		Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.	No

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