NCT00097253

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2004

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

November 19, 2004

Results QC Date

April 23, 2009

Last Update Submit

February 12, 2010

Conditions

Keywords

AromatherapySmell

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (3)

Lavender

EXPERIMENTAL
Behavioral: Exposure to relaxant and stimulant odors

Citrus

EXPERIMENTAL
Behavioral: Exposure to relaxant and stimulant odors

Water

PLACEBO COMPARATOR
Behavioral: Exposure to relaxant and stimulant odors

Interventions

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.

Also known as: Citrus: lemon.
CitrusLavenderWater

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults with a normal sense of smell

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Institute for Biobehavioral Medicine Research

Columbus, Ohio, 43210, United States

Location

Related 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.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionAnosmia

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Janice K. Kiecolt-Glaser, PhD
Organization
The Ohio State University, Department of Psychiatry

Study Officials

  • Janice Kiecolt-Glaser, PhD

    Ohio State University Institute for Biobehavioral Medicine Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

November 19, 2004

First Posted

November 22, 2004

Study Start

August 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

February 18, 2010

Results First Posted

February 4, 2010

Record last verified: 2010-02

Locations