UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055433 |
|---|---|
| Receipt number | R000063335 |
| Scientific Title | Visual feedback of continuous bedside pressure mapping to optimize patient repositioning A One-Group Pre-and Post-Comparison Study of Utilization in Team Medicine |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2025/09/08 07:23:37 |
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Basic information
Public title
Visual feedback of continuous bedside pressure mapping to optimize patient repositioning
A One-Group Pre-and Post-Comparison Study of Utilization in Team Medicine
Acronym
Visual feedback of continuous bedside pressure mapping to optimize patient repositioning
A One-Group Pre-and Post-Comparison Study of Utilization in Team Medicine
Scientific Title
Visual feedback of continuous bedside pressure mapping to optimize patient repositioning
A One-Group Pre-and Post-Comparison Study of Utilization in Team Medicine
Scientific Title:Acronym
Visual feedback of continuous bedside pressure mapping to optimize patient repositioning
A One-Group Pre-and Post-Comparison Study of Utilization in Team Medicine
Region
| Japan |
Condition
Condition
Nurses working in the palliative care unit
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in the use of a `fully automatic actuated pressure-switching air mattress` with a pressure mapping function for the trunk, which is at high risk of developing pressure ulcers
1.What knowledge about pressure ulcers will change
2.What behaviors toward pressure ulcer prevention care will change
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Number of position changes
2.Number of small changes
3.Number of positioning pillows used
Key secondary outcomes
1.Questionnaire survey on the subject's knowledge of pressure ulcers
2.Behavioral survey on pressure ulcer prevention
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
| Device,equipment |
Interventions/Control_1
Period of time that the mapping monitor of the `Fully Automatic Operation Pressure Switching Air Mattress` with body pressure mapping monitor was turned on and used
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Nurses working in the Palliative Care Unit
2. Nurses who have been fully informed and have given their free and voluntary written consent to participate in this study.
Key exclusion criteria
1. Nurses who are working after the introduction of `fully automatic actuated pressure-switching air mattresses` with a pressure mapping function for the torso
2. Nurses who cannot give consent to participate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | junko |
| Middle name | |
| Last name | sugama |
Organization
Fujita Health University
Division name
School of Health Sciences Nursing Science
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-9948
junko.sugama@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | junko |
| Middle name | |
| Last name | sugama |
Organization
Fujita Health University
Division name
School of Health Sciences Nursing Science
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562-93-9948
Homepage URL
junko.sugama@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-9948
junko.sugama@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 | 09 | Month | 05 | 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
31
Results
1) Changes in Nurses' Knowledge
There was a significant difference (p=0.023, p=0.007) in "Causes and Mechanisms of Occurrence" "Classification". There was no change in "risk assessment," "nutrition," "measures related to reducing pressure/shear force," "measures related to reducing time spent applying pressure/shear force," and "total number of correct answers" (p = 0.965, p = 1.000, p = 0.058, p = 0.508, p = 0.378).
Results date posted
| 2025 | Year | 03 | Month | 08 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063335
