UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028673 |
|---|---|
| Receipt number | 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 09:42:18 |
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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
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
waka-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
