UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042366
Receipt number R000048363
Scientific Title Effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction: A crossover test
Date of disclosure of the study information 2020/11/06
Last modified on 2022/07/08 23:26:56

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Basic information

Public title

Effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction: A crossover test

Acronym

Effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction

Scientific Title

Effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction: A crossover test

Scientific Title:Acronym

Effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction

Region

Japan


Condition

Condition

Gambling addiction

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aimed to evaluate the physiological and psychological effects of tactile stimulation with solid wood of Japanese cedar on adult male patients with gambling addiction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Prefrontal activity using near-infrared spectroscopy
2) Sympathetic and parasympathetic nervous activity as indicated by 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
5) Modified Japanese version of the South Oaks Gambling Screen
6) Zung Self-rating Depression Scale


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 uncoated wood of Japanese cedar (60 s) -> Rest time (300 s) -> Tactile stimulation with marble (60 s)

Interventions/Control_2

Tactile stimulation with marble (60 s) -> Rest time (300 s) -> Tactile stimulation with uncoated wood of Japanese cedar (60 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

60 years-old >=

Gender

Male

Key inclusion criteria

Adult male patients with gambling addiction

Key exclusion criteria

1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness
3) Subjects who are deemed by the principle investigator as inappropriate participants for this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshifumi
Middle name
Last name Miyazaki

Organization

Chiba University

Division name

Center for Environment, Health and Field Sciences

Zip code

2770882

Address

6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan

TEL

04-7137-8184

Email

ymiyazaki@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Yoshifumi
Middle name
Last name Miyazaki

Organization

Chiba University

Division name

Center for Environment, Health and Field Sciences

Zip code

2770882

Address

6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan

TEL

04-7137-8184

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 log wholesalers' association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committees 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

2020 Year 11 Month 06 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

22

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

2020 Year 09 Month 10 Day

Date of IRB

2020 Year 10 Month 01 Day

Anticipated trial start date

2020 Year 10 Month 03 Day

Last follow-up date

2020 Year 11 Month 28 Day

Date of closure to data entry

2021 Year 04 Month 01 Day

Date trial data considered complete

2021 Year 10 Month 01 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 11 Month 06 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=R000048363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name