NCT01443871

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

September 28, 2011

Last Update Submit

May 26, 2015

Conditions

Keywords

Volunteer

Outcome Measures

Primary Outcomes (1)

  • electroencephalography (EEG) changes

    The EEG was assessed for 10 minutes in each period; baseline, during and after inhaled the essential oil

    baseline, 10 minutes

Study Arms (2)

Aromatherapy

EXPERIMENTAL

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.

Other: Aromatherapy

Pure water

PLACEBO COMPARATOR

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.

Other: Pure water

Interventions

Subject will assigned inhale aromatherapy

Aromatherapy

Subject will assigned inhale Pure water

Pure water

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 years old

You may not qualify if:

  • excessive nasal congestion
  • neurological disorders prior to participation in the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Surasak Saokaew

Muang, Changwat Phayao, 56000, Thailand

Location

University of Phayao

Muang, Changwat Phayao, 56000, Thailand

Location

MeSH Terms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Surasak Saokaew, PhD

    University of Phayao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations