UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056871 |
|---|---|
| Receipt number | R000064999 |
| Scientific Title | Efficacy test of hot and cold stimulation on mental fatigue load |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/08/01 09:25:19 |
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Basic information
Public title
Efficacy test of hot and cold stimulation on mental fatigue load
Acronym
Efficacy test of hot and cold stimulation on mental fatigue load
Scientific Title
Efficacy test of hot and cold stimulation on mental fatigue load
Scientific Title:Acronym
Efficacy test of hot and cold stimulation on mental fatigue load
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of warm and cold stimuli on mental fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS
Key secondary outcomes
-Tissue oxygen saturation at the measurement site
-Lateral cervical depth temperature
-Forehead skin temperature
- External auditory meatus temperature
-Two-dimensional mood scale
-Questionnaire
- VAS
-PVT
-Cognitive Task Score
-Autonomic function
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply sheet formulation for 30 minutes during load work -> washout period -> load work only
Interventions/Control_2
load work only -> washout period -> Apply sheet formulation for 30 minutes during load work
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Regular employees working at the Sumida Plant of Kao Corporation
2. Those who have been working mainly at a desk for the past two weeks
3. Those who feel head fatigue due to desk work in the last two weeks.
Key exclusion criteria
1.Those who are currently undergoing treatment for a disease
2.You are currently taking medication
3.Pregnant or suspected to be pregnant
4.Those with sensitivity to cold
5.Those who are uncomfortable with cold stimuli such as menthol stimulation
6.Those who have difficulty or are uncomfortable with the use of compresses
7.Those who do not like the smell of bergamot or mint
8.Those who have skin problems such as eczema at the site where the questionnaire product is applied.
9.Those who are already participating in other research studies at the time of receiving explanations about the research, or those who plan to participate in other research studies during the period of cooperation for participation in this study.
10.Those who are deemed by the principal investigator to be unsuitable to participate in the research due to non-compliance or other reasons.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kitano |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8405
kitano.junko@kao.com
Public contact
Name of contact person
| 1st name | Miharu |
| Middle name | |
| Last name | Ikigaki |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-7614-3997
Homepage URL
ikigaki.miharu@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2025 | Year | 01 | Month | 31 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | 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
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064999
