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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032809
Receipt No. R000037426
Scientific Title Effect of touching wooden sheet flooring with the sole of the foot
Date of disclosure of the study information 2018/05/31
Last modified on 2020/12/01

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Basic information
Public title Effect of touching wooden sheet flooring with the sole of the foot
Acronym Effect of touching wooden sheet flooring with the sole of the foot
Scientific Title Effect of touching wooden sheet flooring with the sole of the foot
Scientific Title:Acronym Effect of touching wooden sheet flooring with the sole of the foot
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 touching wooden sheet flooring with the sole of the foot in female university students, using psychological and physiological 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) Profile of Mood State
2) Modified semantic differential method
3) Kwansei Gakuin (KG) daily life questionnaire
4) 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 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Tactile stimulation with wooden sheet flooring (90 s) -> Washout period -> Tactile stimulation with sanding wood of Japanese cedar (90 s)
Interventions/Control_2 Tactile stimulation with sanding wood of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with wooden sheet flooring (90 s)
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
30 years-old >
Gender Female
Key inclusion criteria Healthy person
Key exclusion criteria 1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness
3) Subjects deemed inappropriate to participate in this study by the principle investigator
4) Subjects with menstruation during the study period
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 Natural 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 Natural 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 Tokyo wood cooperatives
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Forestry and Forest Products Research Institute
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-rinri@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
2018 Year 05 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 31 Day
Date of IRB
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 05 Month 31 Day
Last follow-up date
2022 Year 12 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
2018 Year 05 Month 31 Day
Last modified on
2020 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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