UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000029089
Receipt No. R000033270
Scientific Title The effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar
Date of disclosure of the study information 2017/09/11
Last modified on 2020/09/08 (Ver. 6)

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Basic information
Public title The effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar
Acronym The effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar
Scientific Title The effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar
Scientific Title:Acronym The effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to clarify the effect of tactile stimulation with floating wood (Uzukuri) of Japanese cedar on female university students using physiological and psychological indicators.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Near infrared spectroscopy
2) Heart rate variability
3) Heart rate
Key secondary outcomes 1) Modified semantic differential method
2) Kwansei Gakuin (KG) daily life questionnaire
3) Trait Anxiety of State-Trait Anxiety Inventory

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 6
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tactile stimulation with uncoated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with floating wood (Uzukuri) of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with marble (90 s)

Interventions/Control_2 Tactile stimulation with uncoated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with marble (90 s) -> Wash out period -> Tactile stimulation with floating wood (Uzukuri) of Japanese cedar (90 s)
Interventions/Control_3 Tactile stimulation with floating wood (Uzukuri) of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar(90 s) -> Wash out period -> Tactile stimulation with marble (90 s)
Interventions/Control_4 Tactile stimulation with floating wood (Uzukuri) of Japanese cedar(90 s) -> Wash out period -> Tactile stimulation with marble (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar(90 s)
Interventions/Control_5 Tactile stimulation with marble (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar(90 s) -> Tactile stimulation with floating wood (Uzukuri) of Japanese cedar(90 s) -> Wash out period
Interventions/Control_6 Tactile stimulation with marble (90 s) -> Wash out period -> Tactile stimulation with floating wood (Uzukuri) of Japanese cedar(90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar(90 s)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
30 years-old >=
Gender Female
Key inclusion criteria Healthy person
Key exclusion criteria 1)Subjects who are in poor physical condition
2)Subjects who do not have respiratory illnesses
3)Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Miyazaki
Organization Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
Zip code 277-0882
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8113
Email ymiyazaki@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Miyazaki
Organization Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
Zip code 277-0882
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8113
Homepage URL http://www.fc.chiba-u.jp/research/miyazaki/index.html
Email ymiyazaki@faculty.chiba-u.jp

Sponsor
Institute Center for Environment, Health and Field Sciences, Chiba University
Institute
Department

Funding Source
Organization Dentoukenchiku Kazusa Takuminokai Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of the Center for Environment, Health and Field Sciences, Chiba University
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel 04-7137-8010
Email field-jinji@chiba-u.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
2017 Year 09 Month 11 Day

Related information
URL releasing protocol https://jwoodscience.springeropen.com/articles/10.1186/s10086-019-1827-z
Publication of results Published

Result
URL related to results and publications https://jwoodscience.springeropen.com/articles/10.1186/s10086-019-1827-z
Number of participants that the trial has enrolled 21
Results 
Touching brushed or sanded sugi significantly decreased oxy-Hb concentrations in the left and right prefrontal cortices, increased ln(HF), and decreased the ln(LF/(LF？+？HF)) ratio compared with touching marble. Thus, our findings indicate that compared with touching marble, touching sugi with the palm induces physiological relaxation, as indicated by calmer prefrontal cortex activity, higher parasympathetic nervous activity, and lower sympathetic nervous activity.
Results date posted
2019 Year 11 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 09 Month 26 Day
Baseline Characteristics 
Female university students
Participant flow 
Key exclusion criteria
1)Subjects who are in poor physical condition
2)Subjects who do not have respiratory illnesses
3)Subjects deemed inappropriate to participate in this study by the principle
investigator
Adverse events 
None
Outcome measures 
1) Near infrared spectroscopy
2) Heart rate variability
3) Heart rate
4) Modified semantic differential method
5) Kwansei Gakuin (KG) daily life questionnaire
6) Trait Anxiety of State-Trait Anxiety Inventory
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 07 Month 20 Day
Date of IRB
2017 Year 06 Month 30 Day
Anticipated trial start date
2017 Year 09 Month 12 Day
Last follow-up date
2017 Year 09 Month 27 Day
Date of closure to data entry
2019 Year 09 Month 26 Day
Date trial data considered complete
2019 Year 09 Month 26 Day
Date analysis concluded
2019 Year 11 Month 14 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033270