HealthyNCT01443871
Effect of Essential Oils in Aromatherapy on Emotional Relaxation
A study testing Aromatherapy and Pure water in people with Healthy, run by University of Phayao at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aromatherapy and Pure water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 18 years old
Who cannot join
- excessive nasal congestion
- neurological disorders prior to participation in the experiment
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Surasak Saokaew
Muang, Changwat Phayao, 56000
University of Phayao
Muang, Changwat Phayao, 56000
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Aromatherapy, Pure water
- Keywords
- Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Subject will assigned inhale aromatherapy
Pure waterOther
Subject will assigned inhale Pure water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pure water |
What is being measured
The primary outcome is the main question the study is designed to answer.
electroencephalography (EEG) changes
The EEG was assessed for 10 minutes in each period; baseline, during and after inhaled the essential oil
Measured: baseline, 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Phayao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surasak Saokaew, University of Phayao
- Investigators
- Surasak Saokaew, PhD, Principal investigator, University of Phayao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443871
- Sponsor's protocol ID
- WP-5102031
- Status last verified
- May 2015
- First submitted
- 28 Sep 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Essential Oils in Aromatherapy on Emotional Relaxation
- ClinicalTrials.gov ID
- NCT01443871
- Acronym / sponsor ID
- WP-5102031
- Conditions
- Healthy
- Keywords
- Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of PhayaoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: AromatherapyExperimental 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. |
| Pure water | Placebo comparator | Other: Pure waterExperimental 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- > 18 years old
Key exclusion criteria (2 listed)
- excessive nasal congestion
- neurological disorders prior to participation in the experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapySubject will assigned inhale aromatherapy | Other | Aromatherapy |
| Pure waterSubject will assigned inhale Pure water | Other | Pure water |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surasak Saokaew, PhD principal investigator
University of Phayao
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Pure water in people with Healthy, run by University of Phayao at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electroencephalography (EEG) changes (time frame: baseline, 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.