UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025394 |
|---|---|
| Receipt number | 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 | 2020/06/26 10:09:08 |
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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 | SATOKI |
| Middle name | |
| Last name | INOUE |
Organization
Nara Medical University
Division name
Division of Intensive Care
Zip code
634-8521
Address
840 Shijo-cho Kashihara Nara Japan
TEL
0744223051
seninoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | SATOKI |
| Middle name | |
| Last name | INOUE |
Organization
Nara Medical University
Division name
Division of Intensive Care
Zip code
634-8521
Address
840 Shijo-cho Kashihara Nara Japan
TEL
0744223051
Homepage URL
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
Nara Medical University
Address
840 Shijo-cho Kashihara Nara 6348521 Japan
Tel
07442230515276
ino_rinri@naramed-u.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
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
| 2030 | Year | 12 | 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
| 2016 | Year | 12 | Month | 23 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029233
