UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061571 |
|---|---|
| Receipt number | R000070426 |
| Scientific Title | Verification of the sedative effects of lavender essential oil inhalation on anticipatory social anxiety: An investigation using psychological and neuroscientific measures |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/14 17:15:58 |
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Basic information
Public title
The Sedative Effects of Lavender on Social Anxiety and an Examination of Their Psychological and Neuroscientific Mechanisms
Acronym
Sedative effects of lavender on social anxiety
Scientific Title
Verification of the sedative effects of lavender essential oil inhalation on anticipatory social anxiety: An investigation using psychological and neuroscientific measures
Scientific Title:Acronym
Neuropsychological effects of lavender on anticipatory social anxiety
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the calming effects of lavender aroma intervention on social anticipatory anxiety that occurs during the preparation phase of social situations, using subjective state anxiety as the primary outcome measure.
Basic objectives2
Others
Basic objectives -Others
- To investigate the effects of lavender aroma intervention on the quality of task preparation during the preparatory phase of social situations, using task focus and cognitive orientation (whether attention is directed toward anxiety or the task) as secondary outcome measures.
- To elucidate the psychological and neuroscientific mechanisms underlying the calming effects of lavender aroma intervention by analyzing activity patterns in the prefrontal cortex.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective Assessment of Anxiety
Key secondary outcomes
The "Quality of Task Preparation" During the Anticipatory Anxiety Phase and Prefrontal Cortex Activity Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Lavender flavor
Interventions/Control_2
Odorless
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
-Native Japanese speakers
-Individuals who do not experience strong aversion to the scent of lavender
-Right-handed individuals
-Individuals who have never been diagnosed by a doctor with a smell disorder
-Individuals with no fragrance allergies
-Non-smokers
Key exclusion criteria
-Individuals who have been diagnosed by a physician with a disorder of the sense of smell
-Individuals with chronic rhinitis or other conditions that may affect the sense of smell
-Individuals who are pregnant or breastfeeding
-Individuals with a history of severe mental illness or currently undergoing treatment for such conditions
-Individuals with a history of severe neurological disorders (e.g., epilepsy, severe traumatic brain injury, central nervous system disorders) or currently suffering from progressive neurological diseases
-Individuals with severe respiratory diseases or a history of asthma attacks, for whom exposure to fragrances poses a health risk
-Currently undergoing psychotherapy;
-Unable to provide informed consent;
-History of severe allergic reactions to fragrances (e.g., anaphylaxis) or significant fragrance intolerance;
-Physical or cognitive limitations that would interfere with study participation;
-Any other individuals whom the principal investigator determines would compromise the safety or validity of the data in this study.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Clinical Geriatrics Research Division
Zip code
980-0872
Address
4 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture; Tohoku University Institute of Development, Aging and Cancer, Smart Aging Building, 4th Floor
TEL
022-717-8556
nmr_office@grm.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kiwa |
| Middle name | |
| Last name | Tanaka |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Clinical Geriatrics Research Division
Zip code
9800855
Address
4 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture; Tohoku University Institute of Development, A
TEL
08087498211
Homepage URL
tanaka.kiwa.q4@dc.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Institute of Development, Aging and Cancer, Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med*grp@tohoku.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
| 2026 | Year | 05 | Month | 15 | 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
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070426
