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The Effects of Smell on Mood and Physical Responses

Primary Purpose

Stress, Anxiety, Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exposure to relaxant and stimulant odors
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Aromatherapy, Smell

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio State University Institute for Biobehavioral Medicine Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lavender

Citrus

Water

Arm Description

Outcomes

Primary Outcome Measures

Cortisol and Catecholamine Production
Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.
Immune Function
Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.
Skin Barrier Repair
TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6-50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5-7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).
Immune Function: Delayed Hypersensitivity to Candida(DTH)
DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2004
Last Updated
February 12, 2010
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00097253
Brief Title
The Effects of Smell on Mood and Physical Responses
Official Title
Psychoneuroimmunology and Mind-Body Medicine: Olfaction, Mood, and Physiological Responses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression
Keywords
Aromatherapy, Smell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender
Arm Type
Experimental
Arm Title
Citrus
Arm Type
Experimental
Arm Title
Water
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Exposure to relaxant and stimulant odors
Other Intervention Name(s)
Citrus: lemon.
Intervention 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.
Primary Outcome Measure Information:
Title
Cortisol and Catecholamine Production
Description
Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.
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
Title
Immune Function
Description
Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.
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
Title
Skin Barrier Repair
Description
TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6-50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5-7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).
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
Title
Immune Function: Delayed Hypersensitivity to Candida(DTH)
Description
DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.
Time Frame
Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Kiecolt-Glaser, PhD
Organizational Affiliation
Ohio State University Institute for Biobehavioral Medicine Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Institute for Biobehavioral Medicine Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18178322
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. doi: 10.1016/j.psyneuen.2007.11.015.
Results Reference
result
Links:
URL
http://www.stressandhealth.org/
Description
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