UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009009 |
|---|---|
| Receipt number | R000009038 |
| Scientific Title | Can Visual stimulation reduces patient discomfort during screening colonoscopy?: randomized control trial |
| Date of disclosure of the study information | 2012/09/30 |
| Last modified on | 2015/04/26 21:18:37 |
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Basic information
Public title
Can Visual stimulation reduces patient discomfort during screening colonoscopy?: randomized control trial
Acronym
Vistual stimulation and colonoscopy
Scientific Title
Can Visual stimulation reduces patient discomfort during screening colonoscopy?: randomized control trial
Scientific Title:Acronym
Vistual stimulation and colonoscopy
Region
| Japan |
Condition
Condition
Patients scheduled colonoscopy
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Colorectal cancer is a major neoplasm worldwide, and both its prevalence and mortality have been increasing. Colonoscopy and polypectomy have been to shown to reduce the risk of future development of colorectal cancer and advanced adenoma. However colonoscopy is generally toloerated, soome patients regarding the procedure as unpleasant and painful and performed with analgesics. The aim of this study is to investigate the effect of visual stimulation for patient discomfort during screening colonoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The pain score during colonoscopy (visual analog scale)
The anxiety score during colonosocpy (visual analog scale)
The satisfaction score after colonoscopy (visual analog scale)
Key secondary outcomes
Cecal intubation rate
Cecal intubation time
Total procedure time
Vital sign before, during and after colonoscpy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Participants receive colonoscopy putting on head mount display with visual stimulation.
Interventions/Control_2
Participants receive colonoscopy putting on head mount display without visual stimulation.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled colonoscopy.
Key exclusion criteria
History of abdominal surgery
Patitents with visual disability
History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
Pregnancy or possibility of pregnancy
Patients judged as inappropriate candidates for the trial by the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuma Higurashi |
Organization
Yokohama City University Hospital
Division name
Division of gastroenterology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
takuma_h@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Higurashi |
Organization
Yokohama City University Hospital
Division name
Division of gastroenterology
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
takuma_h@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Visual distraction improve patients satisfaction.
Visual distraction reduce pain score especially in patients with anxiety.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 30 | Day |
Last modified on
| 2015 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009038
