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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009706
Receipt No. R000011378
Scientific Title Prospective analysis of reduction of pain in CS by water supply device
Date of disclosure of the study information 2013/01/06
Last modified on 2015/09/21

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Basic information
Public title Prospective analysis of reduction of pain in CS by water supply device
Acronym Prospective analysis of reduction of pain in CS by water supply device
Scientific Title Prospective analysis of reduction of pain in CS by water supply device
Scientific Title:Acronym Prospective analysis of reduction of pain in CS by water supply device
Region
Japan

Condition
Condition CS
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify which water supply device can reduce its pain in CS
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes O2Sat and pulse rate
Key secondary outcomes Pain Score by questionnaires

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Perform CS with water supply device
Interventions/Control_2 Perform CS without water supply device
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients reciened CS
Key exclusion criteria It depends on Physician judgement
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba Univeristy
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL 043-226-2083
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto
Organization Chiba University
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku,Chiba, Japan
TEL 043-226-2083
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba Univeristy
Institute
Department

Funding Source
Organization Chiba Univeristy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Chiba Fundation for health promotion and disease prevention
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 01 Month 06 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 01 Month 06 Day
Last modified on
2015 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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