UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A compared study of sleep pattern between two physical situations attached a drain on surface: short length drain attachment and long drain attachment
Title of the study (Brief title)	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	Natsuki Kamitani
Organization	Mie University Hospital, Department of Nursing
Division name	10th Southern ward
Address	Mie Prefecture, Tsu City, Edobashi 2-174, JAPAN
TEL	059-232-1111
Email	natsuki@imail.sv.hosp.mie-u.ac.jp

Public contact
Name of contact person	Natsuki Kamitani
Organization	Mie University Hospital, Department of Nursing
Division name	10th Southern ward
Address	Mie Prefecture, Tsu City, Edobashi 2-174, JAPAN
TEL	059-232-1111
Homepage URL
Email	natsuki@imail.sv.hosp.mie-u.ac.jp

Sponsor
Institute	Mie University Hospital, Department of Nursing
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040866