UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060018 |
|---|---|
| Receipt number | R000068379 |
| Scientific Title | Geranium essential oil and Autonomic Nervous System Study: randomized crossover trial in hospital staff |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/08 17:46:39 |
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Basic information
Public title
Effects of geranium essential oil on autonomic nervous system in hospital staff: a randomized crossover study.
Acronym
G-ANS Study
Scientific Title
Geranium essential oil and Autonomic Nervous System Study: randomized crossover trial in hospital staff
Scientific Title:Acronym
G-ANS
Region
| Japan |
Condition
Condition
Stress-related symptoms
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of geranium on the autonomic nervous system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following investigation will examine the alterations in heart rate variability (HRV) and the LF/HF ratio in the immediate period preceding and following the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A 10 minute oil treatment was applied to one arm using 0.1% diluted geranium essential oil.
Interventions/Control_2
10 minute oil treatment for one arm using only base oil (macadamia nut oil).
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subject is a healthy individual employed at Dokkyo Medical University Nikko Medical Center, with no history of significant physical or mental illness. The individual in question has been the recipient of a sufficient explanation and has provided written consent.
Key exclusion criteria
The following criteria were considered in the exclusion of subjects from the study: allergies to geranium essential oil or macadamia nut oil; pregnancy or breastfeeding; history of diagnosis with heart disease, respiratory disease, autonomic nervous system disorders, or mental illness; hypersensitivity to fragrances; extreme sleep deprivation or immediately after night shifts; constraints that would interfere with interventions or measurements; recent initiation of medications affecting the autonomic nervous system; or individuals deemed unsuitable by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Masubuchi |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Pharmacy
Zip code
321-1298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
r-masubuchi@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Masubuchi |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of Pharmacy
Zip code
321-1298
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
Homepage URL
r-masubuchi@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Department of Pharmacy
Ryuichiro Masubuchi
Institute
Department
Personal name
Funding Source
Organization
None
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
Dokkyo Medical University Nikko Medical Center Bioethics Committee
Address
145-1 Moritomo, Nikko City, Tochigi Prefecture
Tel
0288-23-7000
rinshokenkyu@dokkyomed.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 | 12 | 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
| 2025 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068379
