UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061962 |
|---|---|
| Receipt number | R000070903 |
| Scientific Title | Effects of the presence or absence of warm towel use during vinyl-bag hand bathing on subjective evaluation, skin temperature, stratum corneum moisture content, and cleansing efficacy |
| Date of disclosure of the study information | 2026/06/18 |
| Last modified on | 2026/06/18 14:22:01 |
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Basic information
Public title
Effects of the use of warm towels in combination with vinyl-bag hand bathing on subjective evaluation, skin temperature, stratum corneum moisture content, and cleansing efficacy
Acronym
Effects of vinyl-bag hand bathing with the use of warm towels
Scientific Title
Effects of the presence or absence of warm towel use during vinyl-bag hand bathing on subjective evaluation, skin temperature, stratum corneum moisture content, and cleansing efficacy
Scientific Title:Acronym
Effects of vinyl-bag hand bathing with the use of warm towels
Region
| Japan |
Condition
Condition
Healthy Adul
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of the presence or absence of warm towel use during vinyl-bag hand bathing on subjective evaluation, skin temperature, stratum corneum moisture content, and cleansing efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a.Physiological parameters
1.Skin temperature
2.Stratum corneum moisture content
3.Cleansing efficacy
b. Subjective evaluation
1.Hot and cold sensation
2.Comfort-discomfort sensation
Key secondary outcomes
a. Background information
1. Age 2. Gender
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the use of warm towels
Interventions/Control_2
no use of warm towels
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria
Participants who meet the following conditions:
1. No wounds or skin diseases on the right hand.
2. No allergies to the materials used in the experiment.
3. Able to participate in the experiment at the same time on both days.
4. No decorative nail treatments, such as artificial nails, gel nails, or sculptured nails, during the two experimental days
Key exclusion criteria
Participants who do not meet the above inclusion criteria.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Kira |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka Meguro Tokyo
TEL
03-5779-5031
r-kira@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Kira |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka Meguro Tokyo
TEL
03-5779-5031
Homepage URL
r-kira@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Healthcare University
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
The Ethical Review Board for Human-related Research, Tokyo Healthcare University
Address
4-1-17 Higashigotanda Shinagawa Tokyo
Tel
03-5721-7655
rinri@thcu.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
東京医療保健大学 東が丘看護学部（東京都）
Tokyo Healthcare University Higashigaoka Faculty of Nursing（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070903
