UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about the association between mental QOL and pain in colonoscopy
Title of the study (Brief title)	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	Eiji Yamada
Organization	Yokohama City University Hospital
Division name	Division of gastroenterology
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	0457872640
Email	eiji@yokohama-cu.ac.jp

Public contact
Name of contact person	Eiji Yamada
Organization	Yokohama City University Hospital
Division name	Division of gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/internalmedicine/56/4/56_56.7465/_article/-char/ja/
Results	The mental health and physical function are important determinants of colonoscopy-related pain.
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015785