UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019101 |
|---|---|
| Receipt number | R000022042 |
| Scientific Title | Effect of autonomic nerve function and autoantibody on mental health -Prospective study about effect of fragrance- |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/09/28 13:19:42 |
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Basic information
Public title
Effect of autonomic nerve function and autoantibody on mental health -Prospective study about effect of fragrance-
Acronym
Effect of fragrance on mental health
Scientific Title
Effect of autonomic nerve function and autoantibody on mental health -Prospective study about effect of fragrance-
Scientific Title:Acronym
Effect of fragrance on mental health
Region
| Japan |
Condition
Condition
College students who visited counseling rooms
Classification by specialty
| Neurology | Psychiatry | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mental health status from the aspects of autonomic nerve function, autoantibodies against neurons and higher brain functions. Besides, study the effect of fragrances, those could adjust the function of autonomic nerve from the aspect of autonomic nerve function and higher brain function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nerve function evaluated by the spectral analyses of heart rate variability within one week after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Spray a favorite perfume to one's neck, once in every morning for a week using an atomizer. Then subjects receive the evaluation tests. After the evaluation, switch the atomizer to one containing distilled water. Subjects were asked for using it for a week.
Interventions/Control_2
Spray distilled water to one's neck, once in every morning for a week using an atomizer. Then subjects receive the evaluation tests. After the evaluation, switch the atomizer to one containing a perfume that felt comfortable for subjects. Subjects were asked for using it for a week.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
College students who visited the counseling rooms
Key exclusion criteria
1. Students who have serious mental diseases
2. Students who attempted suicide
3. Students who have suicidal ideation
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Yoshikawa |
Organization
Kanazawa University
Division name
Health Service Center
Zip code
Address
Kakumamachi, Kanazawa, Ishikawa
TEL
076-264-5254
hokekan@kenroku.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Yoshikawa |
Organization
Kanazawa University
Division name
Health Service Center
Zip code
Address
Kakumamachi, Kanazawa, Ishikawa
TEL
076-264-5254
Homepage URL
hokekan@kenroku.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University, Health Service Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
金沢大学保健管理センター（石川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
