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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005554
Receipt No. R000006567
Scientific Title Analysis of the Physiological Mechanism of Aromatherapy by Biological Sensing Technology
Date of disclosure of the study information 2011/05/11
Last modified on 2014/06/19

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Basic information
Public title Analysis of the Physiological Mechanism of Aromatherapy by Biological Sensing Technology
Acronym Analysis of the Physiological Mechanism of Aromatherapy
Scientific Title Analysis of the Physiological Mechanism of Aromatherapy by Biological Sensing Technology
Scientific Title:Acronym Analysis of the Physiological Mechanism of Aromatherapy
Region
Japan

Condition
Condition young healthy adults
Classification by specialty
Medicine in general Psychiatry Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the physiological mechanism of aroma massage through the recovery process of the stressed brain treated with aromatherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Central nervous system activity
Electroencephalograph (EEG), cerebral blood flow

2. Peripheral physiological response
1) Physiological data:
Electrocardiogram, Volume pulse wave, Core body temperature, Respiratory rate, Blood pressure, Skin electrical conducitivity
2) Biochemical data (blood tests):
cortisol, noradrenaline, IgA, IFN, IL-1, IL-6, WBC count, neutrophil count, lymphocyte count, CD4/8, NK cell activity
3) Basal metabolic rate

3. Psychological response
POMS (profile of mood state)
VAS(Visual analogue scale)

Before and after three months intervention.
Key secondary outcomes Stress Control

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Control and treatment groups are set up.
Fundamental researches of the physiological mechanism of the aromatherapy by various stress tasks.
1. pain stress task
2. Mental stress task
3. exercise task

Short-term test:
1. Baseline, stress, essential oils massage (60 minutes), stress.

2. Baseline, stress, a rest in the relaxation room (60 minutes), stress.

Long-term test:
The subjects whose stress does not improve by the short-term testing are selected, and aroma massage is given to them once every two weeks for three months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy young adults
2. Ages 18 years to 40 years
3. Those who evaluate the smell and the density of the aroma oil used as, "Favorable" or "Pleasant" (six points or more according to the VAS evaluation).
4. Those whose informed consent can be obtained.
Key exclusion criteria Inappropriate subjects for this study judged by the diagnosticians.
1. Those who have severe heart, liver or kidney disease.
2. Those who have a tendency to develop allergy by plants and perfume.
3. Those who have tested positive to an allergy test.
4. Those who received full body massage with aroma oil within one month.
5. Those who cannot agree to participate in this trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Usami
Organization Kobe University Graduate School of Heath Sciences
Division name Department of Biophysics Division of Nutrition and Metabolism
Zip code
Address 7-10-2, Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL 078-792-2555
Email musa@kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomomi Bohgaki
Organization Naragakuen University
Division name Faculty of Health Sciences
Zip code
Address 3-15-1,Nakatomigaoka, Nara-shi, Nara.
TEL 0742-95-9800
Homepage URL
Email bohgaki@naragakuen-u.jp

Sponsor
Institute Kobe University Graduate School of Heath Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science

National Institute of Information and Communications Technology, Advanced ICT Reserch Institute
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 愛知医科大学(愛知県)、神戸大学大学院(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.4236/jbbs.2014.41002
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2011 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 04 Day
Last modified on
2014 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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