UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060640 |
|---|---|
| Receipt number | R000069356 |
| Scientific Title | A Study on Vital Sign Changes and Safety Before and After Home Bathing Service in the Terminal Phase :Analysis Using Secondary Data |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/10 11:59:12 |
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Basic information
Public title
A Study on Vital Sign Changes and Safety Before and After Home Bathing Service in the Terminal Phase
Acronym
A Study on Vital Sign Changes and Safety Before and After Home Bathing Service in the Terminal Phase
Scientific Title
A Study on Vital Sign Changes and Safety Before and After Home Bathing Service in the Terminal Phase :Analysis Using Secondary Data
Scientific Title:Acronym
A Study on Vital Sign Changes and Safety Before and After Home Bathing Service in the Terminal Phase :Analysis Using Secondary Data
Region
| Japan |
Condition
Condition
Terminal home care patients
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This analysis aims to examine safe bathing criteria based on vital sign data such as blood pressure, using terminal-stage user data managed by visiting bathing service providers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in blood pressure before and after bathing
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Select data that meets the following three requirements:
1.Individuals aged 40 and over requiring care levels 1 to 5
2.Home Bathing Service Users
3.At the time of the final service provided within 30 days prior to death
Key exclusion criteria
1.Data from service provision at least 30 days prior to death
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Watanabe |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Nursing, School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-Gun, Ibaraki.
TEL
029-840-2173
w.shino1029@gmail.com
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Watanabe |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Nursing, School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-Gun,Ibaraki
TEL
029-840-2173
Homepage URL
w.shino1029@gmail.com
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Shinobu Watanabe
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Research Ethics Committee
Address
4669-2 Ami, Ami-machi, Inashiki-Gun, Ibaraki.
Tel
029-888-4000
kyoumu@ipu.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
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Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data describing bathing services provided with the consent of the terminally ill patient and their family.
Additionally, confirm whether vital signs fluctuate before and after bathing, and examine factors that may influence such fluctuations.
Management information
Registered date
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069356
