UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056437 |
|---|---|
| Receipt number | R000064493 |
| Scientific Title | Development of a non-restrictive hospital gown for safe management of tubes inserted into the body and verification of its effectiveness |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2025/11/05 19:15:14 |
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Basic information
Public title
Development of a non-restrictive hospital gown for safe management of tubes inserted into the body and verification of its effectiveness
Acronym
Development of a non-restrictive hospital gown for safe management of tubes inserted into the body and verification of its effectiveness
Scientific Title
Development of a non-restrictive hospital gown for safe management of tubes inserted into the body and verification of its effectiveness
Scientific Title:Acronym
Development of a non-restrictive hospital gown for safe management of tubes inserted into the body and verification of its effectiveness
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of the developed non-restrictive hospital gowns.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Restraint Ratio
Key secondary outcomes
Rate of self or accidental removal of tubes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Wearing developmental hospital gowns for eligible patients
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in the surveyed wards who were admitted to Fujita Health University Hospital during the survey period
1) 18 years of age or older
2) Persons who have a level of Activity of Daily Living Inventory for Cognitive Impairment at least rank 3 assessed
3) Patients who the nurse judges that physical restraint would be used under normal circumstances
4) Written consent for participation in the research has been obtained from the patient or a legal representative
Nurses who worked in the surveyed wards at Fujita Health University Hospital during the survey period
1) 18 years of age or older
2) Written consent for participation in the research has been obtained from the nurse
Key exclusion criteria
Patients
1. patients with severe clouding of consciousness
2. patients at high risk of self-injury or other harm
3. patients who are deemed inappropriate by the investigator or attending physician.
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Mano |
Organization
Fujita Health University Hospital
Division name
Nursing Department
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2065
hp1.nurse@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Mitamura |
Organization
Fujita Health University Hospital
Division name
Nursing Department
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2111
Homepage URL
kyoko.mitamura@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2024 | Year | 12 | Month | 12 | 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
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064493
