UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of autonomic nerve function and autoantibody on mental health -Prospective study about effect of fragrance-
Title of the study (Brief title)	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	Hiroaki Yoshikawa
Organization	Kanazawa University
Division name	Health Service Center
Address	Kakumamachi, Kanazawa, Ishikawa
TEL	076-264-5254
Email	hokekan@kenroku.kanazawa-u.ac.jp

Public contact
Name of contact person	Hiroaki Yoshikawa
Organization	Kanazawa University
Division name	Health Service Center
Address	Kakumamachi, Kanazawa, Ishikawa
TEL	076-264-5254
Homepage URL
Email	hokekan@kenroku.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University, Health Service Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022042