UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060962 |
|---|---|
| Receipt number | R000069761 |
| Scientific Title | Evaluation of the Effects of Japanese Essential Oil Aromatherapy on Examination-Related Anxiety and Autonomic Nervous System Activity |
| Date of disclosure of the study information | 2026/03/17 |
| Last modified on | 2026/03/17 14:44:01 |
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Basic information
Public title
Effect of Japanese Essential Oil Aromatherapy on Examination-Related Anxiety Reduction and Autonomic Nervous Activity
Acronym
Japanese Aromatherapy for Stress and Medical Intervention Nervous systEm
Scientific Title
Evaluation of the Effects of Japanese Essential Oil Aromatherapy on Examination-Related Anxiety and Autonomic Nervous System Activity
Scientific Title:Acronym
JASMINE Study Japanese Aromatherapy for Stress and Medical Intervention Nervous systEm
Region
| Japan |
Condition
Condition
Malignant Neoplasms in Patients Undergoing FDG-PET/CT
Classification by specialty
| Radiology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Japanese essential oil aromatherapy on examination-related anxiety in patients undergoing FDG-PET/CT using the State-Trait Anxiety Inventory-State (STAI-S).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in State-Trait Anxiety Inventory-State (STAI-S) scores measured at baseline, immediately before the examination, and after the examination.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Control group: Water vapor is intermittently diffused for 30 minutes using a nebulizing diffuser to reproduce an environment without aroma stimulation.
Interventions/Control_2
Japanese essential oils (Citrus unshiu and yuzu) are intermittently diffused for 30 minutes using a nebulizing diffuser.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo FDG-PET/CT for cancer diagnosis at Asahikawa Medical University Hospital
Aged 20 years or older and capable of providing informed consent
No diagnosis of severe cognitive impairment
Judged to be in a stable physical and mental condition and able to undergo the study procedures
No known hypersensitivity or allergy to aromatic components
Provided written informed consent for participation in the study
Key exclusion criteria
History of fragrance hypersensitivity, asthma, or severe anxiety disorders that may cause adverse reactions to aroma stimulation
Use of medications affecting heart rate variability (e.g.,beta blockers or antiarrhythmic drugs) or use of cardiac devices such as pacemakers
Presence of psychiatric disorders or dementia that makes it difficult to appropriately respond to questionnaires
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Nakayama |
Organization
Asahikawa Medical Univerity
Division name
Department of Radiology
Zip code
0788305
Address
2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL
0166682572
m-naka@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Nakayama |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
0788305
Address
2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL
0166682572
Homepage URL
m-naka@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical Univerity
Institute
Department
Personal name
Funding Source
Organization
Aroma Environment Association of Japan
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
Asahikawa Medical University
Address
2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
Tel
0166682572
m-naka@asahikawa-med.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 17 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069761
