UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057352 |
|---|---|
| Receipt number | R000065549 |
| Scientific Title | Effects of forearm bathing on prefrontal cortex function |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/03/21 08:40:20 |
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Basic information
Public title
Effects of forearm bathing on prefrontal cortex function
Acronym
Effects of forearm bathing on prefrontal cortex function
Scientific Title
Effects of forearm bathing on prefrontal cortex function
Scientific Title:Acronym
Effects of forearm bathing on prefrontal cortex function
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of the hemodynamic activity of the prefrontal cortex by forearm bathing on the function of the prefrontal cortex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reaction time and response performance on the Stroop task, a frontal lobe functional task
Key secondary outcomes
Prefrontal cortex activity
Autonomic nerve activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1. Rest for 5 minutes
2. Stroop task
3. Rest for 5 minutes
4. Forearm bathing
Forearm bathing means that subjects immerse in bath water up to the elbow joint.
5. Stroop task during forearm bathing
After an interval of 7 to 10 days
6. Rest for 5 minutes
7. Stroop task
8. Rest for 5 minutes
9. Non-forearm bathing
Non-forearm bathing means that subjects place up to the elbow joint in a bathtub without hot water.
10. Stroop task during non-forearm bathing
Interventions/Control_2
1. Rest for 5 minutes
2. Stroop task
3. Rest for 5 minutes
4. Non-Forearm bathing
Non-forearm bathing means that subjects place up to the elbow joint in a bathtub without hot water.
5. Stroop task during non-forearm bathing
After an interval of 7 to 10 days
6. Rest for 5 minutes
7. Stroop task
8. Rest for 5 minutes
9. Forearm bathing
Forearm bathing means that subjects immerse in bath water up to the elbow joint.
10. Stroop task during forearm bathing
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects of the study must satisfy all of the following conditions.
1. Able to participate in both forearm and non-forearm baths for two days
2. Right-handed
3. Have no abnormality on physical examination
4. No skin disease on the upper limbs
Key exclusion criteria
The following persons are excluded from the research subjects.
1. Persons with color blindness
2. Those who are in menstrual period on the day of measurement
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hori |
Organization
University of Toyama
Division name
Behavioral Science, Graduate School of Medicine, University of Toyama
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, 930-0194, Japan
TEL
076-434-7480
hori@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Yamazaki |
Organization
Toyama Prefectural University
Division name
Faculty of Nursing
Zip code
930-0975
Address
2-2-78 Nishinagae, Toyama-shi, 930-0975 Japan
TEL
076-464-5410
Homepage URL
c-yamazaki@pu-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani, Toyama-shi, 930-0194, Japan
Tel
076-415-8857
rinri@adm.u-toyama.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 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065549
