UMIN-CTR Clinical Trial

Public title

Effect of tactile stimulation with Japanese cedar that was treated with hot spring

Acronym

Effect of tactile stimulation with Japanese cedar that was treated with hot spring

Scientific Title

Effect of tactile stimulation with Japanese cedar that was treated with hot spring

Scientific Title:Acronym

Effect of tactile stimulation with Japanese cedar that was treated with hot spring

Region

Japan

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We aim to clarify the effect of tactile stimulation with Japanese cedar, treated with hot spring, on female university students using physiological and psychological indicators.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 of Japanese cedar with hot spring treatment (90 s) -> Wash out period -> Tactile stimulation with urethane-coated wood of Japanese cedar (90 s)

Interventions/Control_2

Tactile stimulation with uncoated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with urethane-coated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation of Japanese cedar with hot spring treatment (90 s)

Interventions/Control_3

Tactile stimulation of Japanese cedar with hot spring treatment (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with urethane-coated wood of Japanese cedar (90 s)

Interventions/Control_4

Tactile stimulation of Japanese cedar with hot spring treatment (90 s) -> Wash out period -> Tactile stimulation with urethane-coated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar (90 s)

Interventions/Control_5

Tactile stimulation with urethane-coated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation with uncoated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation of Japanese cedar with hot spring treatment (90 s)

Interventions/Control_6

Tactile stimulation with urethane-coated wood of Japanese cedar (90 s) -> Wash out period -> Tactile stimulation of Japanese cedar with hot spring treatment (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

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

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

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

Institute

Center for Environment, Health and Field Sciences, Chiba University

Institute

Department

Personal name

Organization

Dentoukentiku Kazusa Takuminokai Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

09

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2017

Year

07

Month

20

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

11

Day

Last modified on

2020

Year

09

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033275