UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061405 |
|---|---|
| Receipt number | R000070242 |
| Scientific Title | A Study on Factors That Inhibit Well-Being in Workplace Environments |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/27 17:49:52 |
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Basic information
Public title
A Study on Factors That Inhibit Well-Being in Workplace Environments
Acronym
A Study on Factors That Inhibit Well-Being in Workplace Environments
Scientific Title
A Study on Factors That Inhibit Well-Being in Workplace Environments
Scientific Title:Acronym
A Study on Factors That Inhibit Well-Being in Workplace Environments
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research project focuses on social communication-such as workplace meetings and discussions-which serves as a primary context in which stressors arise in workplace environments. Through in-situ measurements conducted during everyday meetings as well as controlled experiments using simulated meeting settings, the project aims to develop technologies for alleviating workplace stressors, thereby reducing workers' stress and contributing to improvements in their Quality of Life (QoL) and overall well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome of this research is the evaluation of the effects on meeting participants' subjective well-being based on multimodal data, including audio signals and speech content extracted from voice recordings, as well as physiological and behavioral data (e.g., heart rate and sleep states) collected via smartwatches.
Key secondary outcomes
Questionnaire responses assessing personality traits and psychological and physical states
Questionnaire responses related to the categorization and characteristics of meetings
Speech feature extraction based on audio data recorded during meetings
Speech-to-text extraction from audio data recorded during meetings
Heart rate data collected during meetings
Sleep behavior data measured using smartwatches
Smartwatch-based activity data, including step count, physical activity level, heart rate, and energy expenditure
Audio data collected during simulated meeting demonstrations
Video data collected during simulated meeting demonstrations
Body movement data captured during simulated meeting demonstrations
Heart rate data recorded during simulated meeting demonstrations
Gaze (eye-tracking) data collected during simulated meeting demonstrations
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study does not involve any specific intervention requiring participants to engage in additional physical activities or tasks beyond their normal routines. Data are collected during regularly conducted workplace meetings. Similarly, simulated meeting sessions are designed to reflect everyday meeting settings, in which participants are provided with typical agendas and roles and are asked to demonstrate meetings as they would normally occur in daily life.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants classified as internal members must meet all of the following criteria:
1) Be employed at the research implementing institution
2) Be able to provide written informed consent to participate in the study of their own free will
3) Be between 18 and under 70 years of age at the time consent is obtained
4) Be familiar with operating a personal computer (PC)
Participants classified as external members must meet all of the following criteria:
1) Be able to provide written informed consent to participate in the study of their own free will
2) Be between 18 and under 70 years of age at the time consent is obtained
3) Have experience in theatrical performance (acting)
4) Be able to travel independently to the experimental site
5) Be familiar with operating a personal computer (PC)
Key exclusion criteria
Not applicable
Target sample size
1100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Chikai |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
3058566
Address
Higashi 1-1-1, Tsukuba, Ibaraki, Japan
TEL
050-3521-2559
m-chikai@aist.go.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Chikai |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
3058566
Address
Higashi 1-1-1, Tsukuba, Ibaraki, Japan
TEL
050-3521-2559
Homepage URL
m-chikai@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology Research Ethics Board
Address
Higashi 1-1-1, Tsukuba, Ibaraki, Japan
Tel
029-861-2120
safe-life-ml@aist.go.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
| 2026 | Year | 05 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | 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 | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070242
