UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055165 |
|---|---|
| Receipt number | R000063030 |
| Scientific Title | Physiological effects of aroma-treatments |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2024/08/05 16:47:48 |
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Basic information
Public title
Physiological effects of aroma-treatments
Acronym
aroma-treatments
Scientific Title
Physiological effects of aroma-treatments
Scientific Title:Acronym
aroma-treatments
Region
| Japan |
Condition
Condition
health
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of aroma treatment are investigated on biological changes, health status, and mood changes using wearable devices and questionnaires.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
biological data by weareble devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
aroma-treatment
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
attach devices.
Key exclusion criteria
hard to attach devices.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kakeyama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6723
fname-waseda@list.waseda.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kakeyama |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa
TEL
04-2947-6723
Homepage URL
fname-waseda@list.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
2-579-15 Mikajima, Tokorozawa
Tel
04-2947-6723
fname-waseda@list.waseda.jp
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
| 2024 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063030
