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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014260
Receipt No. R000016609
Scientific Title Mental and Physical Effect of Aroma Massage: A Randomized Controlled Trial
Date of disclosure of the study information 2014/06/13
Last modified on 2014/06/13

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Basic information
Public title Mental and Physical Effect of Aroma Massage: A Randomized Controlled Trial
Acronym Effect of Aroma Massage: A Randomized Controlled Trial
Scientific Title Mental and Physical Effect of Aroma Massage: A Randomized Controlled Trial
Scientific Title:Acronym Effect of Aroma Massage: A Randomized Controlled Trial
Region
Japan

Condition
Condition normal individuals or
decline of autonomic function
Classification by specialty
Medicine in general Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to investigate the physical and mental effect of aroma massage among normal indivisduals or those with declined automic function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability,
Blood pressure, Heart rate,
Health related QOL (SF8),
State Anxiety (STAI)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Aroma Massage
Interventions/Control_2 Control (Usual life)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria -Regidents around Matsuyama City where the intervention is conducted
-Individuals who are explained about the study, and agreed to participate in the study
-Individuals aged 20-70
Key exclusion criteria -Individuals who have serious illness
-Individuals who have cardiovascular disease
-individuals whose blood pressure is more than 180/110
-individuals whose HR at rest is more than 110 or under 50
-Those who have serious arrhythmia
-Those who are pregnant
-Those who need to stop activities
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Eguchi
Organization Graduate School of Medicine, Ehime University
Division name Department of Public Health, Social Medicine and Medical Informatics
Zip code
Address 791-0295 Shitsukawa 454, Toon, Ehime
TEL +81-89-960-5283
Email eguchi.eri.mf@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Eguchi
Organization Graduate School of Medicine, Ehime University
Division name Department of Public Health, Social Medicine and Medical Informatics
Zip code
Address 791-0295 Shitsukawa 454, Toon, Ehime
TEL +81-89-960-5283
Homepage URL
Email eguchi.eri.mf@ehime-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Ehime University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministory of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Ehime University
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
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 Open public recruiting
Date of protocol fixation
2013 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 07 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
2014 Year 06 Month 13 Day
Last modified on
2014 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016609


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