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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041297
Receipt No. 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

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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
Email 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
Email yuriko.w1@gmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047154

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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