UMIN-CTR Clinical Trial

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

young healthy adults

Classification by specialty

Medicine in general	Psychiatry	Nursing
Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kobe University Graduate School of Heath Sciences

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛知医科大学（愛知県）、神戸大学大学院（兵庫県）

Date of disclosure of the study information

2011

Year

05

Month

11

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2011

Year

05

Month

04

Day

Last modified on

2014

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006567