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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039596
Receipt No. R000043842
Scientific Title Development of the technique of footbath to get to sleep in the elderly who needs help of the life
Date of disclosure of the study information 2020/03/31
Last modified on 2020/09/22

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Basic information
Public title Development of the technique of footbath to get to sleep in the elderly who needs help of the life
Acronym Development of the technique of footbath to get to sleep in the elderly who needs help of the life
Scientific Title Development of the technique of footbath to get to sleep in the elderly who needs help of the life
Scientific Title:Acronym Development of the technique of footbath to get to sleep in the elderly who needs help of the life
Region
Japan

Condition
Condition Elderly person to need support of the everyday life
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research aims at clarifying influence which footbath has on sleep,and body temperature of the elderly people who need to support everyday life.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sleeping hours,the number of times and time of a halfway arousals,sleep efficiency
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 footbath(10 minutes,temperature of comfortable hot water)
Interventions/Control_2
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Over 80 years old
Persons to need support everyday life
Persons living in home for elderly people
Key exclusion criteria The person who takes a sleeping drug
Target sample size 13

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Maeda
Organization Kumamoto University
Division name Faculty of Life Science
Zip code 862-0976
Address 4-24-1,kuhonji,Chuo-ku,Kumamoto
TEL 096-373-5476
Email hmaeda@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Arao
Organization Kumamoto Health Science University
Division name Department of Nursing
Zip code 861-5598
Address 325 Izumi-machi,Kumamoto-city
TEL 096-275-2111
Homepage URL
Email arao@kumamoto-hsu.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto Health Science University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto University Research Ethics Committee
Address 1-1-1,Honjo,Chuo-ku,Kumamoto
Tel 096-373-5637
Email byi-senshin@jimu.kumamoto-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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 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
2020 Year 02 Month 06 Day
Date of IRB
2020 Year 08 Month 31 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 25 Day
Last modified on
2020 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043842

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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