UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058150 |
|---|---|
| Receipt number | R000066464 |
| Scientific Title | Effects of Hand Bathing or Towel Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/11 15:49:05 |
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Basic information
Public title
Effects of Hand Bathing or Towel Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Acronym
Effects of Hand Bathing or Towel Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Scientific Title
Effects of Hand Bathing or Towel Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Hand Bathing or Towel Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
To assess the effects of hand bathing or towel bathing on noise-induced vasoconstriction.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Healthy university students aged 18 years or older
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toe skin temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
One minute of hand bathing during five minutes of noise exposure
Interventions/Control_2
One minute of towel bathing during five minutes of noise exposure
Interventions/Control_3
five minutes of noise exposure
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
Healthy university students aged 18 years or older
Key exclusion criteria
(1) Undergoing treatment for cardiovascular diseases
(2) Undergoing treatment for ear disorders or diseases (including medical history)
(3) Undergoing treatment for hand skin disorders or diseases
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Sugawara |
Organization
Mie Prefectural College of Nursing
Division name
School of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie, Japan
TEL
059-233-5600
keita.sugawara@mcn.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sugawara |
Organization
Mie Prefectural College of Nursing
Division name
School of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie, Japan
TEL
059-233-5600
Homepage URL
keita.sugawara@mcn.ac.jp
Sponsor or person
Institute
Mie Prefectural College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie Prefectural College of Nursing Research Ethics Committee
Address
1-1-1 Yumegaoka, Tsu, Mie, Japan
Tel
059-233-5600
keita.sugawara@mcn.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 | 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
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
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066464
