UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057796 |
|---|---|
| Receipt number | R000066001 |
| Scientific Title | Development of a screening tool for presenteeism using thermal grill illusions |
| Date of disclosure of the study information | 2025/05/08 |
| Last modified on | 2026/05/12 03:19:58 |
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Basic information
Public title
Development of a screening tool for presenteeism using thermal grill illusions
Acronym
Development of a screening tool for presenteeism
Scientific Title
Development of a screening tool for presenteeism using thermal grill illusions
Scientific Title:Acronym
Development of a screening tool for presenteeism
Region
| Japan |
Condition
Condition
university student, worker
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of the thermal grill illusion in screening for presenteeism. To identify the characteristics of those for whom presenteeism is predictable/difficult to predict.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presennteeism
Key secondary outcomes
VAS-pain, sleep
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have consented to the research
Key exclusion criteria
pregnant woman
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Sasaki |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
r.sasaki@kio.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sasaki |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan
TEL
0745-54-1601
Homepage URL
r.sasaki@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745541601
r.sasaki@kio.ac.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
| 2025 | Year | 05 | Month | 08 | 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 | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. To assess the following questionnaires
WHO Health and Work Performance Questionnaire (short form) Japanese edition
Single-Item Presenteeism Question
Pittsburgh Sleep Questionnaire Index
Brief Fatigue Inventory
Brief Job Stress Questionnaire
International Physical Activity Questionnaire
Brief Pain Inventory
Hospital Anxiety & Depression Scale
Pain Catastrophizing Scale
Central Sensitization Inventory
EuroQol-5Dimension-5Level
2. measurement of resting EEG and electrocardiogram
3. Performed the thermal grill illusion three times and assessed pain, heat, and discomfort during the illusion using the VAS
Management information
Registered date
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066001
