UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024781 |
|---|---|
| Receipt number | R000028390 |
| Scientific Title | Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit |
| Date of disclosure of the study information | 2016/12/31 |
| Last modified on | 2016/11/07 00:28:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Acronym
Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Scientific Title
Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Scientific Title:Acronym
Efficacy of Sleep Bundles for Patients who Admitted to Cardiovascular Care Unit
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Cardiology | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the determinants of sleep disorders, and the efficacy of sleep bandle in patients who admitted to cardiovascular care unit (CCU)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of sleep evaluated by patients themselves at second day morning after admission by using our original questionnaire based on the Richards-Campbell Sleep Questionnaire (RCSQ)(Subjective assessments)
Key secondary outcomes
Quality of sleep evaluated by nurses during first night period after admission by using our original questionnaire (Objective assessments)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep bandle
(Our original vesion based on the previous report by Patel et al)
<Reducing Sound> From 10 p.m. to 6 a.m.
1. Monitoring panels
2. Mechanical Supports
3. Phones
4. Voices from between healthcare providers and patients
5. Voices from between healthcare providers and families
6. Earplugs are provided to all patients
<Reducing Light> From 10 p.m. to 6 a.m.
1. Darken a room
2. Using a light at bedside, if nursing care is performed
3. Eye pads are provided to all patients
<Nursing care> From 10 p.m. to 6 a.m.
1. Shoud be avoided during above period
2. Time, place and date are told to patients every 8 hours
3. Pain scale is evaluated every 2 hours and its optimizatation is performed
4. Control sleep disorders and derilium
Interventions/Control_2
Control:without the sleep bandle
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Staying at CCU for more than 48 hours
2. Can understand the questionnars and fill the form
Key exclusion criteria
1. No emergency admission
2. Mechanical ventilation
3. Using IV sedative drugs
4. Dementia
5. Derilium at first day
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Ozaki |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Care Unit
Zip code
Address
5-7-1 Fujishiro-dai,Suita,Osaka 565-8565,Japan
TEL
06-6833-5012
ozaki.mika@ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Ozaki |
Organization
National Cerebral and Cardiovascular Center
Division name
Cardiovascular Care Unit
Zip code
Address
5-7-1 Fujishiro-dai,Suita,Osaka 565-8565,Japan
TEL
06-6833-5012
Homepage URL
ozaki.mika@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立循環器病研究センター/National Cerebral and Cardiovascular Center
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 28 | 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 | 11 | Month | 10 | Day |
Last modified on
| 2016 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028390
