UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037637 |
|---|---|
| Receipt number | R000042917 |
| Scientific Title | Effects of forest-derived sound on adult male patients with gambling addiction: A crossover test |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2020/09/08 12:05:42 |
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Basic information
Public title
Effects of forest-derived sound on adult male patients with gambling addiction: A crossover test
Acronym
Effects of forest-derived sound on adult male patients with gambling addiction
Scientific Title
Effects of forest-derived sound on adult male patients with gambling addiction: A crossover test
Scientific Title:Acronym
Effects of forest-derived sound 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 auditory stimulation of forest-derived sound 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
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
Auditory stimulation of the murmur of a brook as a forest sound (60 s) -> Rest time (300 s) -> Auditory stimulation of a street intersection as an urban sound (60 s)
Interventions/Control_2
Auditory stimulation of a street intersection as an urban sound (60 s) -> Rest time (300 s) -> Auditory stimulation of the murmur of a brook as a forest sound (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
4) Subject who had hearing impairment
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
Nature Therapy Laboratory
Zip code
2770882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8184
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
Nature Therapy Laboratory
Zip code
2770882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
0471378184
Homepage URL
http://www.fc.chiba-u.jp/research/miyazaki/index.html
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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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, Japan
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel
04-7137-8010
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
| 2019 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2071-1050/12/15/5969
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2071-1050/12/15/5969
Number of participants that the trial has enrolled
12
Results
This study examined the physiological and psychological reactions of gambling disorder (GD) patients while listening to forest or city sounds. Twelve Japanese male GD patients were exposed to sound for 1 min via headphones. Oxy-Hb levels of the bilateral prefrontal cortices were lower when patients listened to forest sounds. This is the first study to show that sounds of forest relaxed individuals physiologically and psychologically to minimize GD.
Results date posted
| 2020 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 24 | Day |
Baseline Characteristics
Adult male patients with gambling addiction.
Participant flow
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
4) Subject who had hearing impairment
Adverse events
None.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | 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=R000042917
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