UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041297 |
|---|---|
| Receipt number | R000047154 |
| Scientific Title | - Effective Medical Creation Project - Evaluation of the Effect of Wood and its Materials in Prevention of Delirium and in Patient/Family/Medical personnel Satisfaction |
| Date of disclosure of the study information | 2020/08/03 |
| Last modified on | 2020/08/03 18:43:56 |
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Basic information
Public title
- Effective Medical Creation Project - Evaluation of the Effect of Wood and its Materials in Prevention of Delirium and in Patient/Family/Medical personnel Satisfaction
Acronym
Effective Medical Creation - Healthcare Environment improvement project
Scientific Title
- Effective Medical Creation Project - Evaluation of the Effect of Wood and its Materials in Prevention of Delirium and in Patient/Family/Medical personnel Satisfaction
Scientific Title:Acronym
Evaluation of the Effect of Wood and its Materials in Prevention of Delirium and in Patient/Family/Medical personnel Satisfaction
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This project is a joint venture with Sumitomo Forestry Co., Ltd. to evaluate the effect of wood and wood-like materials on delirium and satisfaction level of patient/family/medical personnel in critical care area.
Basic objectives2
Others
Basic objectives -Others
Measurement of stress related hormones and inflammatory markers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of delirium and patient/family/medical personnel satisfaction
Key secondary outcomes
Duration of delirium, use of sedative/analgesia, sleep quality, severity of illness (APACHE II), NRS (Numerical Rating Scale), CPOT (Critical-Care Pain Observation Tool), RASS (Richmond Agitation Severity Scale), Medical Cost
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Wood styled wall paper and aroma diffuser
Interventions/Control_2
Wood styled wall paper
Interventions/Control_3
Aroma diffuser
Interventions/Control_4
Control
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 older than 18years of age admitted to critical care area (ICU/HCU) in Tokyo Medical and Dental University
Key exclusion criteria
- Patients with impairment of visual and olfactory senses
- Unable to obtain consent from patient or family
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidenobu |
| Middle name | |
| Last name | Shigemitsu |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Department of Intensive Care Medicine
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5959
hshigemi@gmail.com
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Wada |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Intensive Care Unit
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5959
Homepage URL
yuriko.w1@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Forestry Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
東京医科歯科大学医学部附属病院
Tokyo Medical and Dental University
Medical Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 03 | 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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047154
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
