UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055200 |
|---|---|
| Receipt number | R000063077 |
| Scientific Title | Quantitative evaluation of the effects of an occupational therapy approach to flow state and performance |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/02/08 09:11:13 |
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Basic information
Public title
Quantitative evaluation of the effects of an occupational therapy approach to flow state and performance
Acronym
Quantitative evaluation of the effects of an occupational therapy approach to flow state and performance
Scientific Title
Quantitative evaluation of the effects of an occupational therapy approach to flow state and performance
Scientific Title:Acronym
Quantitative evaluation of the effects of an occupational therapy approach to flow state and performance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of an occupational therapy approach on flow state and performance using electroencephalography and electrocardiography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electrocardiography (before and after the intervention)
Key secondary outcomes
electrocardiography, saliva amylase, The Flow State Scale for Occupational Tasks (FSSOT), occupational performance (before and after the intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Occupational therapy approaches such as oral feedback
Interventions/Control_2
non-intervention
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy individual, right-handed
Key exclusion criteria
brain disease, heart disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Sakaguchi |
Organization
Hyogo Medical University
Division name
Faculty of Rehabilitation
Zip code
650-8530
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3141
yu-sakaguchi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Okutani |
Organization
Hyogo Medical University
Division name
Faculty of Rehabilitation
Zip code
650-8530
Address
6-3-1 minatojima tyu-o-ku, kobe
TEL
078-304-3140
Homepage URL
okutani@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
| 2024 | Year | 08 | Month | 09 | 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 | 08 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063077
