UMIN-CTR Clinical Trial

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