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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042366
Receipt No. 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 2021/01/06

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

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 No longer recruiting
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
2021 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.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


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