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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034793
Receipt No. R000039677
Official scientific title of the study 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

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Basic information
Official scientific title of the study Effect of hand bathing on the coldness of young women
Title of the study (Brief title) 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 Naomi Iwane
Organization Wakayama Prefectural Medical University
Division name Faculty of Health Nursing
Address 580,Mitsukata,Wakayama city
TEL 073-446-6709
Email iwane-na@wakayama-med.acj.jp

Public contact
Name of contact person Naimi Iwane
Organization Wakayama Prefectural Medical University
Division name Faculty of Health Nursing
Address 580,Mitsukata,Wakayama city
TEL 073-446-6709
Homepage URL
Email iwane-na@wakayama-med.acj.jp

Sponsor
Institute Wakayama Prefectural Medical University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 05 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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