UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063095 |
|---|---|
| Receipt number | R000072227 |
| Scientific Title | Intervention Study on Non-Pharmacological Delirium Prevention for Patients in High Care Units |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/09/29 14:20:07 |
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Basic information
Public title
Intervention Study on Non-Pharmacological Delirium Prevention for Patients in High Care Units
Acronym
Intervention Study on Non-Pharmacological Delirium Prevention in HCU
Scientific Title
Intervention Study on Non-Pharmacological Delirium Prevention for Patients in High Care Units
Scientific Title:Acronym
Intervention Study on Non-Pharmacological Delirium Prevention in HCU
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will implement non-pharmacological interventions aimed at preventing delirium for patients in our hospital's High Care Unit (HCU). Specifically, the intervention involves engaging patients in conversation during the day and having them watch videos of their choice to promote wakefulness; this aims to maintain the daytime circadian rhythm and ensure nighttime sleep, thereby preventing delirium. We will evaluate the efficacy of this intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delirium, delirium-free days, survival rate, length of hospital stay, duration of HCU stay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using a DVD player, the patient watches a video selected from a list of video titles for 30 minutes each at 10:00 a.m. and 2:00 p.m.
Interventions/Control_2
don't intervene
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following criteria are eligible:
1) Patients expected to be admitted to the hospital's HCU for 7 days or longer
2) Patients aged 20 years or older at the time of obtaining consent
3) Gender: No restriction
4) Patients who have provided written consent of their own free will, based on a full understanding after receiving a thorough explanation regarding participation in this study
Key exclusion criteria
Patients meeting any of the following criteria shall be excluded from this study:
1) Patients with a history of dementia
2) Patients with a history of severe mental illness
3) Patients already in a state of delirium upon admission to the HCU
4) Patients with organic central nervous system disorders
5) Patients expected to remain in a prolonged coma
6) Patients with severe difficulty in language comprehension
7) Patients receiving end-of-life or palliative care
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Shiramoto |
Organization
Kanmon Medical Center
Division name
Department of Anesthesiology
Zip code
7528510
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
TEL
0832411199
k_shiramoto@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Shiramoto |
Organization
Kanmon Medical Center
Division name
Department of Anesthesiology
Zip code
7528510
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
TEL
0832411199
Homepage URL
https://kanmon.hosp.go.jp/aboutus/rinshoukenkyu.html
k_shiramoto@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Kanmon Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
National Hospital Organization Kanmon Medical Center
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
Tel
0832411199
511-KanmonChiken@mail.hosp.go.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
| 2026 | Year | 10 | 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
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 | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 05 | 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
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072227
