UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013510 |
|---|---|
| Receipt number | 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 21:16:23 |
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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
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
eiji@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
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 |
