UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047464 |
|---|---|
| Receipt number | R000053923 |
| Scientific Title | Exploratory study of singing effects on mental health |
| Date of disclosure of the study information | 2023/04/18 |
| Last modified on | 2024/04/23 18:18:00 |
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Basic information
Public title
Exploratory study of singing effects on mental health
Acronym
Exploratory study of singing effects on mental health
Scientific Title
Exploratory study of singing effects on mental health
Scientific Title:Acronym
Exploratory study of singing effects on mental health
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to thoroughly verify some kind of singing effect on mental health
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Simplified questionnaire survey about mental stress (simple ver.: 23 questions)
Key secondary outcomes
1. Tongue-color analysis using the Tongue Image Analyzing System
2. Flicker
3. Acceleration of pulse waveform
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Karaoke-singing 4 songs a time, at the appointed time and place.
Interventions/Control_2
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 and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 20 to 59.
(2) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily in the health-specific/functional/supplementary/health foods which might affect this trial, and will have any difficulty in giving up taking them after the consent.
(2) Subjects who have taken affecting medicines (e.g., anxiolytic, sleeping pill, antidepressant, and sleep-inducing drug), and have any difficulty in refraining from taking them during this trial.
(3) Subjects who have been diagnosed as depression, or are now under medical treatment for the symptom.
(4) Pregnant, possibly pregnant, and lactating women.
(5) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those tests within four weeks before this trial, or planning to join those after the consent.
(6) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Crane Science Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DAIICHIKOSHO CO.,LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2023 | Year | 04 | Month | 18 | 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
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
| 2022 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
