- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00097253
The Effects of Smell on Mood and Physical Responses
Psychoneuroimmunology and Mind-Body Medicine: Olfaction, Mood, and Physiological Responses
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Institute for Biobehavioral Medicine Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Water
|
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 Names:
|
Experimental: Lavender
|
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 Names:
|
Experimental: Citrus
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
|
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)
Time Frame: Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Janice Kiecolt-Glaser, PhD, Ohio State University Institute for Biobehavioral Medicine Research
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT002122-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
-
Lawson Health Research InstituteTerminated
Clinical Trials on Exposure to relaxant and stimulant odors
-
AlyatecCompletedValidation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With AsthmaAllergy | Allergic Asthma | Allergy to CatsFrance
-
Bispebjerg HospitalRigshospitalet, DenmarkUnknownPediatric | Neonatal | Excipient Exposure
-
Central Hospital, Nancy, FranceUnknown
-
University of GeorgiaRecruitingMessage Exposure (Sequence: Regular Then Flavor) | Message Exposure (Sequence: Flavor Then Regular) | No Message Exposure (Control Condition)United States
-
Santiago R. Leal-NovalInstituto de Salud Carlos IIIUnknownGlioma | Surgery | Coagulopathy | Acquired Platelet Function Disorder | ThromboelastometrySpain
-
MASK-air SASCompletedAllergic Rhinitis Due to Pollen | Allergic Rhinitis With AsthmaFrance
-
AlyatecCompletedAllergy | Allergic Asthma | Allergy to House DustFrance
-
University of ArizonaRecruiting
-
Karolinska InstitutetCompletedIllness Anxiety Disorder | Somatic Symptom Disorder | Severe Health AnxietySweden