UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058163 |
|---|---|
| Receipt number | R000066477 |
| Scientific Title | The effects of combined foam-based cleaning and hot towel application for foot hygiene on cleanliness level, physiological responses, and subjective evaluation |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/12/12 16:21:21 |
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Basic information
Public title
The effects of combined foam-based cleaning and hot towel application for foot hygiene on cleanliness level, physiological responses, and subjective evaluation: A comparison with basin bathing
Acronym
The effects of foam-based cleaning and hot towel application on foot hygiene
Scientific Title
The effects of combined foam-based cleaning and hot towel application for foot hygiene on cleanliness level, physiological responses, and subjective evaluation
Scientific Title:Acronym
The effects of foam-based cleaning and hot towel application on foot hygiene
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined foam-based cleaning and hot towel application on cleansing efficacy, physiological parameters, and subjective evaluations in foot hygiene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a.Physiological parameters
1.Skin surface temperature(dorsum of the foot center of the supraclavicular fossa)
2.Tympanic temperature
3.Sweat volume
4.Pulse rate
5.Blood pressure
b.Subjective evaluation
1.Hot and cold sensation
2.Comfort-discomfort sensation
C.Cleansing efficacy
Key secondary outcomes
a. Background information
1.Age 2. Gender
b. To prevent low-temperature burns, the surface temperature of the towel during application of the hot cloth in the foam-washed hot cloth method is measured using an infrared thermography device (HIKMICRO Mini2 V2Thermal Image), and the temperature of the water during the foot bath in the basin method is continuously measured and observed using a water thermometer.
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
Foam-based cleaning and hot towel application
Interventions/Control_2
Foot bath
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
Inclusion Criteria
Participants who meet the following conditions:
1.No wounds or disease on the feet.
2.No known allergy to the hand hygiene checker (Product name: Hand hygiene checker lotion.)
3.No known allergy to the body soap (Product name: Kao Biore U Body Wash Pump).
4.Able to participate in the experiment at the same time for two consecutive days.(For female participants, the experiment must be conducted within one week after the end of menstruation to avoid the luteal phase.)
5.Students whose foot size is less than 25.0 cm.
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 | Tomoko |
| Middle name | |
| Last name | Takahashi |
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
0357795031
to-takahashi@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
1528558
Address
2-5-1 Higashigaoka, Meguro,Tokyo
TEL
03-5779-5031
Homepage URL
to-takahashi@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
Other
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
YES
Study ID_1
S25-01E
Org. issuing International ID_1
The Ethical Review Board for Human-related Research, Tokyo Healthcare University
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
| 2025 | Year | 06 | Month | 12 | 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
36
Results
Cleansing efficacy was significantly higher with the foam-based cleaning and hot towel method than with the basin method. Skin temperature increased significantly with both methods. No significant differences were found in pulse rate or blood pressure. Thermal sensation was significantly higher with the foam-based method, with no difference in comfort-discomfort ratings.
Results date posted
| 2025 | Year | 12 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
With approval from the facility director and the dean of the department, recruitment flyers were distributed to potential participants, and volunteers were publicly recruited.
Adverse events
nothing
Outcome measures
Plan to share IPD
Nothing in particular.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 11 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066477
