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
Results First Received: April 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Stress
Anxiety
Depression
Intervention: Behavioral: Exposure to relaxant and stimulant odors

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through ads posted in the Columbus, Ohio area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We excluded individuals taking cardiovascular medications or medications with obvious immunological or endocrinological consequences. Additional exclusion criteria included perfume allergies, smoking, problems with smell/taste, respiratory problems, asthma, excessive alcohol/caffeine use.

Reporting Groups
  Description
Lavender Oil / Lemon Oil / Water Control A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).

Participant Flow for 3 periods

Period 1:   Lavender
    Lavender Oil / Lemon Oil / Water Control  
STARTED     56  
COMPLETED     56  
NOT COMPLETED     0  

Period 2:   Lemon
    Lavender Oil / Lemon Oil / Water Control  
STARTED     56  
COMPLETED     56  
NOT COMPLETED     0  

Period 3:   Water (Control)
    Lavender Oil / Lemon Oil / Water Control  
STARTED     56  
COMPLETED     56  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Lavender Oil / Lemon Oil / Water Control A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).

Baseline Measures
    Lavender Oil / Lemon Oil / Water Control  
Number of Participants  
[units: participants]
  56  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     56  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  24.41  ± 6.05  
Gender  
[units: participants]
 
Female     35  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     56  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Janice K. Kiecolt-Glaser, PhD
Organization: The Ohio State University, Department of Psychiatry
phone: 614-292-0033
e-mail: Kiecolt-Glaser.1@osu.edu


Publications of Results:

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