UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054348 |
|---|---|
| Receipt number | R000062070 |
| Scientific Title | Effects of Hand-Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2025/03/13 19:07:27 |
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Basic information
Public title
Effects of Hand-Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Acronym
Effects of Hand-Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Scientific Title
Effects of Hand-Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Scientific Title:Acronym
Effects of Hand-Bathing on Noise-Induced Vasoconstriction: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy university students aged 20 years or older
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to assess the effect of hand bathing on sympathetic nervous activity exacerbated by psychological stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature of right fingertip
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
2 minutes hand bathing during 6 minutes noise exposure ( 1 time)
Interventions/Control_2
6 minutes noise exposure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy university students aged 20 years or older
Key exclusion criteria
Persons who fulfil any of the following
(1) Cardiovascular disease receiving treatment
(2) Ear disorders, or ongoing treatment for such conditions (including relevant medical history)
(3) Skin disorders or ongoing treatment of hand-related conditions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Sugawara |
Organization
Mie Prefectural College of Nursing
Division name
Department of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie
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
Department of Nursing
Zip code
514-0116
Address
1-1-1 Yumegaoka, Tsu, Mie
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
Tel
059-233-5600
yuuto.satou@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
三重県立看護大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/jjns.12625
Number of participants that the trial has enrolled
29
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
For submission to academic journals.
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 07 | Day |
Baseline Characteristics
Healthy university students aged 20 years or older
(1) Hand bathing group
Average age 21, 13 females, 1 male
(2) Control group
Average age 21, 14 females
Participant flow
Twenty-nine individuals (one male) who provided consent were randomly allocated to either the hand-bathing group (14 participants, including the one male) or the control group (15 participants). In addition, the coauthors randomly assigned the subjects to the hand bath group and the control group using a random number table.
Adverse events
One control group member stopped the experiment for health reasons (mood discomfort).
Outcome measures
Skin temperature of right fingertip
Tympanic temperature
Skin blood flow of right fingertip
Blood pressure
Overall body temperature sensation
Thermal comfort
Relaxation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062070
