UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014260 |
|---|---|
| Receipt number | 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 19:48:06 |
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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
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
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
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
eguchi.eri.mf@ehime-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Ehime University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016609
