UMIN-ICDS 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

Email

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


Email

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


Email



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/icdr_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