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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025394
Receipt No. R000029233
Scientific Title The effects of living environment on recovery profile and stress response in critically ill patients
Date of disclosure of the study information 2017/01/01
Last modified on 2017/12/24

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Basic information
Public title The effects of living environment on recovery profile and stress response in critically ill patients
Acronym Living environment in ICU
Scientific Title The effects of living environment on recovery profile and stress response in critically ill patients
Scientific Title:Acronym Living environment in ICU
Region
Japan

Condition
Condition critical ill patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether living environment in ICU can affect stress response and recovery profile in critically ill patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VAS for stress, salivary alpha amylase, RR varability, progression of rehabilitation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 sense of vision:decoration
Interventions/Control_2 olfaction:aromatherapy
Interventions/Control_3 tactile sensation:massage
Interventions/Control_4 auditory sense:music
Interventions/Control_5 gustatory sensation:meal
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria non
Key exclusion criteria non
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoki Inoue
Organization Nara Medical University
Division name Division of Intensive Care
Zip code
Address 840 Shijo-cho Kashihara Nara Japan
TEL 0744223051
Email seninoue@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoki Inoue
Organization Nara Medical University
Division name Division of Intensive Care
Zip code
Address 840 Shijo-cho Kashihara Nara Japan
TEL 0744223051
Homepage URL
Email seninoue@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 01 Month 01 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
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029233

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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