UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054630 |
|---|---|
| Receipt number | R000062427 |
| Scientific Title | Investigating the effect of artificial window on patients in hospital room. |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2024/06/11 16:30:16 |
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Basic information
Public title
Investigating the effect of artificial window on patients in hospital room.
Acronym
Investigating the effect of artificial window on patients in hospital room.
Scientific Title
Investigating the effect of artificial window on patients in hospital room.
Scientific Title:Acronym
Investigating the effect of artificial window on patients in hospital room.
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In four-bed hospital rooms, there are beds that do not face a window. The effect of treatment in beds without windows may be less effective than in spaces facing windows, and the installation of artificial windows in beds without windows may be effective in improving sleep efficiency and cognitive dysfunction. In this study, we will install artificial windows in hospital beds that do not face windows, and study changes in patients' physical and psychological stress.
Translated with DeepL.com (free version)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood cortisol hormone, analgesic dosage, sleeping medication dosage, The Confusion Assessment Method (CAM) Japanese version as a delirium assessment tool, measurement of sleep by body movement (Actigraph by ActiGraph, USA will be used), and psychological The evaluation will be conducted by psychological stress assessment using a questionnaire.
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
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
The patients were divided into two groups: (1) a group with beds that do not face a window and (2) a group with beds that do face a window and a artificial-window installed in the beds that do not face a window.
(2) A group of patients with beds that do not face a window, and (3) a group of patients with a artificial-window installed in a bed that does not face a window.
(3) A forest image was shown in the artificial-window.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatients whose consent was obtained after explaining the outline of the study.
The revised Hasegawa brief intelligence assessment (HDS-R) is administered to all inpatients at Kamiya Hospital, and only those with HDS-R>20 will be administered questionnaires such as CAM, etc. Those with HDS-R <20 will be administered other items than the questionnaire.
Key exclusion criteria
In addition to those who did not give consent, the following exclusions are provided
(1) Patients under 65 years old
2) Patients with motor disability due to stroke or other causes
(iii) Patients who cannot wear Actigraph on their non-dominant hand
(iv) Patients with visual impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tanabe |
| Middle name | |
| Last name | Shinichi |
Organization
Waseda University
Division name
Department of Architecture,
Zip code
169-8555
Address
55-N-701, 3-4-1 Okubo, Shinjyuku-ku, Tokyo, 169-8555, Japan
TEL
03-5292-5083
tanabe@waseda.jp
Public contact
Name of contact person
| 1st name | ODA |
| Middle name | |
| Last name | MASAHARU |
Organization
Waseda University graduate school
Division name
School of Creative Science and Engineering, Waseda University graduate school
Zip code
169-8555
Address
55-N-701, 3-4-1 Okubo, Shinjyuku-ku, Tokyo, 169-8555, Japan
TEL
03-5292-5083
Homepage URL
s09-026mo@akane.waseda.jp
Sponsor or person
Institute
School of Creative Science and Engineering, Waseda University
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
Secretariat of the Ethics Review Committee for Research Involving Human Subjects, Waseda University (Research Management Division, Research Promotion Department)
Address
3-4-1 Okubo, Shinjyuku-ku, Tokyo, 169-8555, Japan
Tel
03-5272-1639
rinri@list.waseda.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 | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062427
