UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050660 |
|---|---|
| Receipt number | R000057721 |
| Scientific Title | Study to validate discomfort score values in endoscopy |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/09/24 09:09:59 |
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Basic information
Public title
Study to validate discomfort score values in endoscopy
Acronym
Study to validate discomfort score values in endoscopy
Scientific Title
Study to validate discomfort score values in endoscopy
Scientific Title:Acronym
Study to validate discomfort score values in endoscopy
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will validate a 0-10 pain score (NRS: Numerical Rating Scale) in endoscopy. We will determine the score values that are associated with a comfortable endoscopy , minimal clinically important difference (MCID), and willingness to undergo future examinations.
Basic objectives2
Others
Basic objectives -Others
Validate score.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determining the discomfort score value in comfortable endoscopy.
Determine MCID.
Key secondary outcomes
Determine the discomfort score value corresponding to willingness to undergo examination.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who underwent upper gastrointestinal endoscopy screening or colonoscopy screening.
Key exclusion criteria
Participants who refused to use their information for study.
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
maji-ken@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Majima |
Organization
Kameda Medical Center
Division name
Department of Health Management
Zip code
296-8602
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
TEL
04-7092-2211
Homepage URL
maji-ken@umin.ac.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
self funding, Kameda Medical Center
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
Kameda General Hospital Clinical Research Review Committee Office
Address
929 Higashi-cho, Kamogawa City, Chiba Prefecture, Japan
Tel
04-7092-2211
I can not publish it.
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
| 2023 | Year | 05 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We obtain discomfort score from 0 to 10 (NRS) from participants after endoscopy in routine practice. As a questionnaire survey to validate this discomfort score, we investigate whether the current endoscopy was comfortable, whether it was more comfortable than the previous one, and whether they would like to undergo this endoscopy again in the future. Using this information, we will determine the score values that are associated with a comfortable endoscopy, minimal clinically important difference (MCID), and willingness to undergo future examinations.
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057721
