UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034793 |
|---|---|
| Receipt number | R000039677 |
| Scientific Title | Effect of hand bathing on the coldness of young women |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2018/11/06 22:58:25 |
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Basic information
Public title
Effect of hand bathing on the coldness of young women
Acronym
Effect of hand bathing on the coldness of young women
Scientific Title
Effect of hand bathing on the coldness of young women
Scientific Title:Acronym
Effect of hand bathing on the coldness of young women
Region
| Japan |
Condition
Condition
Chilliness
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study clarifies whether the effects of hand bathing on sleep / wakefulness are different between chilliness and non-chilling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in the drowsiness measurement scale (KSS-J, JUNACLE) before and after bathing
Key secondary outcomes
Difference between peripheral body temperature and deep body temperature before and after bathing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
| Maneuver |
Interventions/Control_1
Hand warming
Interventions/Control_2
do nothing
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
| 28 | years-old | >= |
Gender
Female
Key inclusion criteria
chilling person
(A person who is aware of an abnormal cold sensation in an environment where a person does not feel distressing as usual, and has a state in which the temperature difference between the central temperature and the peripheral temperature is 6 degrees or more)
Non-chilling person
(Person who is not cold person)
Those within 15 days from the previous menstrual date
Key exclusion criteria
Persons with numbness of hands and consciousness of abnormality
Person who has a disorder that may cause hand injury
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Iwane |
Organization
Wakayama Prefectural Medical University
Division name
Faculty of Health Nursing
Zip code
Address
580,Mitsukata,Wakayama city
TEL
073-446-6709
iwane-na@wakayama-med.acj.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naimi Iwane |
Organization
Wakayama Prefectural Medical University
Division name
Faculty of Health Nursing
Zip code
Address
580,Mitsukata,Wakayama city
TEL
073-446-6709
Homepage URL
iwane-na@wakayama-med.acj.jp
Sponsor or person
Institute
Wakayama Prefectural Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Prefectural Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 11 | Month | 08 | 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
| 2018 | Year | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039677
