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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028673
Receipt No. R000032787
Scientific Title - Effective Medical Creation, Comfortable environment project - Effects of Patient-Directed Music Intervention Using Sleep System on Delirium in Critically Ill Patients
Date of disclosure of the study information 2017/08/15
Last modified on 2019/08/16

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Basic information
Public title - Effective Medical Creation, Comfortable environment project -
Effects of Patient-Directed Music Intervention Using Sleep System on Delirium in Critically Ill Patients
Acronym - Effective Medical Creation, Comfortable environment project -
Effects of Patient-Directed Music Intervention Using Sleep System on Delirium in Critically Ill Patients
Scientific Title - Effective Medical Creation, Comfortable environment project -
Effects of Patient-Directed Music Intervention Using Sleep System on Delirium in Critically Ill Patients
Scientific Title:Acronym - Effective Medical Creation, Comfortable environment project -
Effects of Patient-Directed Music Intervention Using Sleep System on Delirium in Critically Ill Patients
Region
Japan

Condition
Condition critically ill patients in ICU
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our research aims to investigate the relation between music and delirium using the sleep system developed at yamaha.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of ICU delirium
Key secondary outcomes duration of ICU delirium, sedation frequency, sedation intensity, length of stay in the post-ICU period, hospital length of stay,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 A group that performs music intervention in an non-intubated patient.
Patients who are conscious will listen to favorite music at any time.
Patients who are unconscious will shed 24 hours autoplay music.
Interventions/Control_2 A group that performs usual care in a non-intubated patient.
Interventions/Control_3 A group that performs music intervention in an intubated patient.
Patients who are conscious will listen to favorite music at any time.
Patients who are unconscious will shed 24 hours autoplay music.
Interventions/Control_4 A group that performs usual care in an intubated patient.
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 any adult admitted to general ICU
Key exclusion criteria severe deafness
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Hidenobu
Middle name
Last name Shigemitsu
Organization Tokyo Medical Dental University Graduate School of Medical and Dental Sciences
Division name Department of Critical Care Medicine
Zip code 113-851
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL 03-5803-0168
Email hshiccm@tmd.ac.jp

Public contact
Name of contact person
1st name kenji
Middle name
Last name wakabayashi
Organization Tokyo Medical Dental University Graduate School of Medical and Dental Sciences
Division name Department of Critical Care Medicine
Zip code 113-8519
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL 03-5803-0168
Homepage URL
Email waka-tmd@umin.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization YAMAHA CORPORATION
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Innovation Promotion Center, Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
Tel 03-5803-4382
Email office.innv@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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 15 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 08 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 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
2017 Year 08 Month 15 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032787

Research Plan
Registered date File name
2017/09/04 研究計画書 快眠.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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