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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014