UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059512 |
|---|---|
| Receipt number | R000062159 |
| Scientific Title | The effects of sex differences and preferences on the psychophysiological status in aromatherapy |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/23 12:29:01 |
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Basic information
Public title
The effects of sex differences and preferences on the psychophysiological status in aromatherapy
Acronym
Efficacy of aromatherapy on the psychophysiological status
Scientific Title
The effects of sex differences and preferences on the psychophysiological status in aromatherapy
Scientific Title:Acronym
Efficacy of aromatherapy on the psychophysiological status
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of sex differences and essential oil preferences on psychophysiological responses including oral immune function during the aromatherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in salivary secretory immunoglobulin A from before to 30 minutes after aromatherapy
Key secondary outcomes
Changes in autonomic nerve activity (sympathetic nerve activity, parasympathetic nerve activity), psychological-related questionnaire (POMS2), and subjectively evaluation-related questionnaire (preference of essential oil and fatigue) from before and 30 minutes after aromatherapy
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Aromatherapy using water (Control)
Interventions/Control_2
Aromatherapy using bergamot essential oil
Interventions/Control_3
Aromatherapy using lavender essential oil
Interventions/Control_4
Aromatherapy using yuzu essential oil
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 18-30 years who understood the purpose and contents of the study and provided written informed consent
Key exclusion criteria
1. Current or past history of severe diseases
2. Constant use the oral medication or supplements potentially affecting the study outcomes
3. Participation in other clinical studies
4. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | SONE |
Organization
Tokyo University of Agriculture
Division name
Faculty of International Agriculture and Food Studies
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2507
rs207923@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | SONE |
Organization
Tokyo University of Agriculture
Division name
Faculty of International agriculture and Food Studies
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2507
Homepage URL
rs207923@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Ryota SONE
Funding Source
Organization
Aroma Environment Association of Japan (AEAJ)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture, The Ethical Committee of Experiment and survey for Human
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo
Tel
03-5477-2532
human@nodai.ac.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
東京農業大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 23 | 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
30
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062159
