UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039596 |
|---|---|
| Receipt number | 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 | 2024/03/07 12:01:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
arao@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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 Health Science University Research Ethics Committee
Address
325,Izumi-machi,Kita-ku,Kumamoto
Tel
096-275-2111
kikaku@kumamoto-hsu.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
Enrolling by invitation
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
| 2026 | 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
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.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 |
