UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062040 |
|---|---|
| Receipt number | R000070975 |
| Scientific Title | Online Experiment on the Coping Effects of Music |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/24 12:11:38 |
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Basic information
Public title
Online Experiment on the Coping Effects of Music
Acronym
Online Experiment on the Coping Effects of Music
Scientific Title
Online Experiment on the Coping Effects of Music
Scientific Title:Acronym
Online Experiment on the Coping Effects of Music
Region
| Japan |
Condition
Condition
Healthy males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the extent to which music listening reduces subjective stress, anxiety, and tension in situations where participants anticipate having to perform another task on the following day. This study also aims to clarify whether individual differences in emotion regulation strategies are associated with the stress-reducing effects of music listening. In addition, as a secondary objective, this study will explore how the selection of emotion regulation strategies changes in response to changes in stress levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological Scales (Subjective Stress, State Anxiety)
Before the start of the study; 5 minutes before the task explanation; 5 minutes before speech preparation; 5 minutes before the Coping task after speech preparation; every 5 minutes after the Coping task, for a total of 4 times; and 15 minutes before debriefing.
Key secondary outcomes
Psychological Scales (Cognitive Emotion Regulation Strategies)
Before the start of the study; 5 minutes before the task explanation; 5 minutes before speech preparation; 5 minutes before the Coping task after speech preparation; every 5 minutes after the Coping task, for a total of 4 times; and 15 minutes before debriefing.
Upload status of the speech-preparation memo, Completion level of the speech preparation, Subjective pleasantness rating after music listening, Coping behaviors(Title and artist name of the music)
After the Coping task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Music listening group:
Participants will listen to music for 30 minutes by playing a playlist that they have prepared in advance. The songs in the playlist will be freely selected by each participant, with a maximum of 15 songs. Participants may listen to the same song repeatedly.
Every 15 minutes, participants will be instructed to press the reaction button on Zoom to confirm that they have not left the screen.
Interventions/Control_2
Control Group:
Participants will remain seated at rest for 30 minutes.
To ensure that they remain present and in front of the screen, they will be instructed to click a Zoom reaction button every 10 minutes.
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
Participants who indicate their willingness to participate and provide informed consent after understanding the study explanation will be included in the research.
In this study, participants will be recruited from the NTT Com Research Monitor, a panel managed by NTT Com Online Marketing Solutions. The NTT Com Research Monitor consists of approximately 8 million registered individuals ranging in age from their teens to their seventies. This service regularly conducts web-based surveys and interviews to collect opinions on systems, policies, and other topics. All registered members have agreed to the terms and conditions regarding information provision, including the handling of personal data, through NTT Com Research.
Participants must meet all of the following criteria:
1)Individuals who understand the contents of this study and provide consent to participate.
2)Healthy men aged 20 to 59 years.
3)Individuals who do not smoke.
4)Individuals who can participate in the study alone from their home via Zoom on the study day.
5)Individuals who have a stable internet connection and are able to use Zoom.
6)Individuals who are able to create a music playlist to be used in the study.
7)Individuals who are able to play the above playlist while participating in Zoom.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded:
1)Individuals whose alcohol consumption habits, assessed using the screening questionnaire, exceed the predefined threshold, specifically the AUDIT score of 8 or higher.
2)Individuals who currently smoke.
3)Individuals who may have difficulty meeting the study environment or study conditions, such as an unstable internet connection, excessive background noise, difficulty remaining seated for an extended period, or difficulty following study instructions.
4)Individuals who have participated in a previous beverage intake study involving beer(UMINID:UMIN000059814).
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mina |
| Middle name | |
| Last name | Takase |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Division name
Neuro-Cognitive Innovation Unit
Zip code
1020093
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
TEL
08013666354
takasemi@nttdata-strategy.com
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Takase |
Organization
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Division name
Neuro-Cognitive Innovation Unit
Zip code
1020093
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
TEL
08013666354
Homepage URL
takasemi@nttdata-strategy.com
Sponsor or person
Institute
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Institute
Department
Personal name
Mina Takase
Funding Source
Organization
Asahi Quality and Innovations .Inc
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
NTT DATA INSTITUTE OF MANAGEMENT CONSULTING,Inc.
Address
JA Kyosai Bldg, 10th Fl., 7-9, Hirakawacho 2-chome, Chuyoda-ku Tokyo 102-0093, Japan
Tel
08013666354
takasemi@nttdata-strategy.com
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
| 2026 | Year | 06 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070975
