UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032809
Receipt number 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 2022/07/08 23:23:15

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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 or person

Institute

Center for Environment, Health and Field Sciences, Chiba University

Institute

Department

Personal name



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

27

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

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

2022 Year 07 Month 08 Day



Link to view the page

Value
https://center6.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