UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041562 |
|---|---|
| Receipt number | R000047448 |
| Scientific Title | A prospective randomized study |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2020/08/26 15:39:22 |
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Basic information
Public title
A prospective randomized study for the influence of music for colonoscopy
Acronym
music colon study
Scientific Title
A prospective randomized study
Scientific Title:Acronym
randomized study
Region
| Japan |
Condition
Condition
colon tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of music for patients during colonoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of STAI before and after colonoscopy
Key secondary outcomes
VAS scale, vital sign, cecum insertion timeand cecum insertion rate before and after colonoscopy. The gender related pain reduction. The age related pain reduction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The patients are listening music during colonoscopy
Interventions/Control_2
questionnaire to the patients before and after colonoscopy (STAI, VAS)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The examination of colon because of the suspicious of colon disease. The first time of colonoscopy. informed consent of the test
Key exclusion criteria
medical history of abdominal surgery, the experience of colonoscopy, colonoscopy under sedation or with analgesic. the symptom of abdominal pain, diarrhea or melena. hearing disorder, colonoscopy with antipsychotic agent or antianxiety agent, Performance status 3 or 4,inappropriate by the doctor
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
mebi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Ebi |
Organization
Aichi medical university
Division name
Gastroenterology
Zip code
4801195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561623311
Homepage URL
mebi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi medical university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
(State)
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi medical university
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561623311
mebi@aichi-med-u.ac.jp
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
| 2020 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047448
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| Registered date | File name |
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