- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01443871
Effect of Essential Oils in Aromatherapy on Emotional Relaxation
May 26, 2015 updated by: Surasak Saokaew, University of Phayao
The purpose of this study is to examine and compare electroencephalography (EEG) changes in human subjects directly after inhalation of essential oils from five Thai aromatherapies.
The investigators hypothesize that essential oils from Thai aromatherapies may influence the human EEG involving emotional relaxation particularly alpha wave EEG.
Study Overview
Detailed Description
The subjects consisted of 22 male and 26 female subjects , ages between 20 to 30 years (mean age, 23.3 years).
They were screened for excessive nasal congestion, drug and food taken, and neurological disorders prior to participation in the experiment.
The experiments were approved by the Ethical Committee for Research Involving Human Research Subject, Naresuan University.
All subjects read and signed an informed consent before participation.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Phayao
-
Muang, Phayao, Thailand, 56000
- Surasak Saokaew
-
Muang, Phayao, Thailand, 56000
- University of Phayao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- > 18 years old
Exclusion Criteria:
- excessive nasal congestion
- neurological disorders prior to participation in the experiment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aromatherapy
Experimental procedures were conducted in the morning.
Subjects individually entered the closed room where the temperature was kept at 25-26 oC and humidity 50-60%.
The subjects were blinded using mask and were seated comfortably with eyes closed during experimental period.
The EEG was recorded using silver electrodes.
EEG activity was monitored 4 areas (F7, F8, T3 and T4) and ground electrodes.
The experiments were divided into 3 parts.
The first part, no-odor were recorded EEG activity for 10 minutes as a baseline.
The second part, subject was exposure to the odor for 10 minutes as during inhalation.
The last part, the odor was dispersed and assessed EEG activity for 10 minutes as after inhalation.
|
Subject will assigned inhale aromatherapy
|
|
Placebo Comparator: Pure water
Experimental procedures were conducted in the morning.
Subjects individually entered the closed room where the temperature was kept at 25-26 oC and humidity 50-60%.
The subjects were blinded using mask and were seated comfortably with eyes closed during experimental period.
The EEG was recorded using silver electrodes.
EEG activity was monitored 4 areas (F7, F8, T3 and T4) and ground electrodes.
The experiments were divided into 3 parts.
The first part, no-odor were recorded EEG activity for 10 minutes as a baseline.
The second part, subject was exposure to the water for 10 minutes as during inhalation.
The last part, the water was dispersed and assessed EEG activity for 10 minutes as after inhalation.
|
Subject will assigned inhale Pure water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
electroencephalography (EEG) changes
Time Frame: baseline, 10 minutes
|
The EEG was assessed for 10 minutes in each period; baseline, during and after inhaled the essential oil
|
baseline, 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Surasak Saokaew, PhD, University of Phayao
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 28, 2011
First Submitted That Met QC Criteria
September 29, 2011
First Posted (Estimate)
September 30, 2011
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WP-5102031
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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