UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059300 |
|---|---|
| Receipt number | R000067832 |
| Scientific Title | Changes in Mood and Autonomic Nervous System Activity During Aromatherapy Soap Making: An Exploratory Study |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 10:55:38 |
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Basic information
Public title
Changes in Mood and Autonomic Nervous System Activity During Aromatherapy Soap Making: An Exploratory Study
Acronym
Changes in Mood and Autonomic Nervous System Activity During Aromatherapy Soap Making: An Exploratory Study
Scientific Title
Changes in Mood and Autonomic Nervous System Activity During Aromatherapy Soap Making: An Exploratory Study
Scientific Title:Acronym
Changes in Mood and Autonomic Nervous System Activity During Aromatherapy Soap Making: An Exploratory Study
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of different aromatic scents Valerian (V), Roman Chamomile (RC), and Lemongrass (LG)used during the task of aromatherapy soap making on subjective mood, perceived fatigue, and autonomic nervous system indices
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inventory Scale for Mood and Sense of Fatigue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Aroma V Soap-Making Group (Valerian)
Interventions/Control_2
Aroma RC Soap-Making Group (Roman Chamomile)
Interventions/Control_3
Aroma LG Soap-Making Group (Lemongrass)
Interventions/Control_4
Non-Aroma Soap-Making Group (Control)
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
Female
Key inclusion criteria
Women aged 18 years or older and under 30 years at the time of obtaining consent
Key exclusion criteria
Individuals who are unable to perform soap making using aromatherapy, or those who have previously experienced allergic reactions or physical discomfort caused by aromatherapy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL
0263372404
sagaria@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sagari |
Organization
Shinshu University
Division name
Division of Occupational Therapy School of Health Science
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621 JAPAN
TEL
0263372404
Homepage URL
sagaria@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Akira Sagari
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Ethics Review Board
Address
3-1-1,Asahi,Matsumoto
Tel
0263-37-3099
mdrinri@shinshu-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067832
