The Effects of Smell on Mood and Physical Responses

Study Overview
=================
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.

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

Conditions
-----------------
Stress, Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Exposure to relaxant and stimulant odors


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender<br> | Behavioral: Exposure to relaxant and stimulant odors<br>* 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.<br>* Other names: Citrus: lemon.;|
| Experimental: Citrus<br> | Behavioral: Exposure to relaxant and stimulant odors<br>* 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.<br>* Other names: Citrus: lemon.;|
| Placebo Comparator: Water<br> | Behavioral: Exposure to relaxant and stimulant odors<br>* 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.<br>* Other names: Citrus: lemon.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol and Catecholamine Production | Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00. | 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 | 
| 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. | 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 | 
| 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). | 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 | 
| 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. | Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aromatherapy, Smell