UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036872 |
|---|---|
| Receipt number | R000041948 |
| Scientific Title | The effect of using blue water on hand bath for relaxation |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/04/10 11:23:52 |
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Basic information
Public title
The effect of using blue water on hand bath for relaxation tergeted female university students
Acronym
The effect of using blue water on hand bath for relaxation
Scientific Title
The effect of using blue water on hand bath for relaxation
Scientific Title:Acronym
The effect of using blue water on hand bath for relaxation
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relaxation effect by using blue colored water for hand bath.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulse, blood pressure, salivary amylase,
Visual Analog Scale for relaxation,
Conduct examinations before and after hand bath.
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
take a hand bath with blue water one time.
Conduct 30 minutes per person, including hand-bath and examinations.
Interventions/Control_2
Take a hand bath with clear water one time.
Conduct 30 minutes per person, including hand-bath and examinations.
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
| 19 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
A female students,in their teens and twenties
Who has no scratches or skin problems
Healthy people who do not have chronic illness
Key exclusion criteria
Male university student
Person of age not teens-twenties
Person with a hand scrathes or skin trouble
People who are not healthy on a daily basis
Person who is in poor health on the day of the implementation
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Tanaka |
Organization
Yamaguchi University
Division name
Division of Fundamental Nursing, Faculty of Health Sciences, Graduate School of Medicine
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2860
aitanaka@yamaguchi-pu.ac.jp
Public contact
Name of contact person
| 1st name | Aiko |
| Middle name | |
| Last name | Tanaka |
Organization
Yamaguchi University
Division name
Division of Fundamental Nursing, Faculty of Health Sciences, Graduate School of Medicine
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2860
Homepage URL
aitanaka@yamaguchi-pu.ac.jp
Sponsor or person
Institute
Division of Fundamental Nursing, Faculty of Health Sciences, Graduate School of Medicine,Yamaguchi university
Institute
Department
Personal name
Funding Source
Organization
Division of Fundamental Nursing, Faculty of Health Sciences, Graduate School of Medicine,Yamaguchi university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board School of Health Sciences
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2111
me202@yamaguchi-u.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
山口大学医学部保健学科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2020 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
