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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013510
Receipt No. R000015785
Scientific Title Study about the association between mental QOL and pain in colonoscopy
Date of disclosure of the study information 2014/04/01
Last modified on 2017/03/21

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Basic information
Public title Study about the association between mental QOL and pain in colonoscopy
Acronym Mental QOL and pain in colonoscopy
Scientific Title Study about the association between mental QOL and pain in colonoscopy
Scientific Title:Acronym Mental QOL and pain in colonoscopy
Region
Japan

Condition
Condition Patients scheduled colonoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Colonoscopy has been to shown to reduce the risk of future development of colorectal cancer and advanced adenoma. However, the impact of mental QOL on pain in colonoscopy is uncertain. The aim of this study is to investigate the impact of mental QOL on pain during screening colonoscopy.
Basic objectives2 Others
Basic objectives -Others n/a
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The pain score during colonoscopy (visual analog scale)
The anxiety score during colonoscopy (visual analog scale)
The satisfaction score after colonoscopy (visual analog scale)
Mental QOL(SF-8)
Key secondary outcomes Cecal intubation rate
Cecal intubation time
Total procedure time
Vital sign before, during and after colonoscopy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients scheduled colonoscopy
Key exclusion criteria Active intra-abdominal and pelvic malignancy
Ulcerative colitis
Crohn`s disease Microscopic colitis
History of abdominal surgery
Active organic GI disorders
Pregnancy or possibility of pregnancy
Patients judged as inappropriate candidates for the trial by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Yamada
Organization Yokohama City University Hospital
Division name Division of gastroenterology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 0457872640
Email eiji@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yamada
Organization Yokohama City University Hospital
Division name Division of gastroenterology
Zip code
Address Kanazawa-ku Yokohama City
TEL 0457872640
Homepage URL
Email eiji@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 横浜市立大学医学部附属病院(Yokohama City University Hospital)
横浜市済世会南部病院(Saiseikai Yokohamashi Nanbu Hospital)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/internalmedicine/56/4/56_56.7465/_article/-char/ja/
Number of participants that the trial has enrolled
Results The mental health and physical function are important determinants of colonoscopy-related pain.
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
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 10 Month 01 Day
Date analysis concluded
2016 Year 01 Month 01 Day

Other
Other related information n/a

Management information
Registered date
2014 Year 03 Month 25 Day
Last modified on
2017 Year 03 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015785

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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