UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035868 |
|---|---|
| Receipt number | R000040866 |
| Scientific Title | A compared study of sleep pattern between two physical situations attached a drain on surface: short length drain attachment and long drain attachment |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2019/02/15 07:59:56 |
* 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
A compared study of sleep pattern between two physical situations attached a drain on surface: short length drain attachment and long drain attachment
Acronym
SQUT-D
Scientific Title
A compared study of sleep pattern between two physical situations attached a drain on surface: short length drain attachment and long drain attachment
Scientific Title:Acronym
SQUT-D
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to compare sleep types between physical situation attaching a short length drain and a long length drain by healthy volunteers.
Basic objectives2
Others
Basic objectives -Others
Improve nursing care during drain insertion.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep efficiency, sleep sufficiency, status of feeling on awake time
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A subject has two experiences during sleep time: physical situation attaching a short length drain
Interventions/Control_2
A subject has two experiences during sleep time: physical situation attaching a long length drain
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Some persons who agreed the study aim and procedure
Key exclusion criteria
Some persons disagreed by a researcher on concerning of inadaptable for this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Natsuki Kamitani |
Organization
Mie University Hospital, Department of Nursing
Division name
10th Southern ward
Zip code
Address
Mie Prefecture, Tsu City, Edobashi 2-174, JAPAN
TEL
059-232-1111
natsuki@imail.sv.hosp.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuki Kamitani |
Organization
Mie University Hospital, Department of Nursing
Division name
10th Southern ward
Zip code
Address
Mie Prefecture, Tsu City, Edobashi 2-174, JAPAN
TEL
059-232-1111
Homepage URL
natsuki@imail.sv.hosp.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital, Department of Nursing
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
| 2018 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | 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
| 2019 | Year | 02 | Month | 13 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040866
