UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033681 |
|---|---|
| Receipt number | R000038399 |
| Scientific Title | A study of the influence on indirect lighting and music for upper gastrointestinal endoscopy examination |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2019/04/30 10:07:34 |
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Basic information
Public title
A study of the influence on indirect lighting and music for upper gastrointestinal endoscopy examination
Acronym
A study of the influence on indirect lighting and music for endoscopy
Scientific Title
A study of the influence on indirect lighting and music for upper gastrointestinal endoscopy examination
Scientific Title:Acronym
A study of the influence on indirect lighting and music for endoscopy
Region
| Japan |
Condition
Condition
Subjects who undergo upper gastrointestinal endoscopic examination
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the influence on indirect lighting and music for upper gastrointestinal endoscopic examination
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, pulse rate, and autonomic nervous function during upper gastrointestinal endoscopic examination
Key secondary outcomes
1. Assessment of psychological items, satisfaction, and tolerance
2. Blood pressure, heart rate, and autonomic nervous function before and after upper gastrointestinal endoscopic examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
sitting on the sofa for ten minutes under the light of the indirect lighting before upper gastrointestinal endoscopic examination
Interventions/Control_2
sitting on the sofa and listening to music for ten minutes before upper gastrointestinal endoscopic examination
Interventions/Control_3
sitting on the sofa and listening to music for ten minutes under the light of the indirect lighting before upper gastrointestinal endoscopic examination
Interventions/Control_4
Control; sitting on the sofa for ten minutes before upper gastrointestinal endoscopic examination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who undergo upper gastrointestinal endoscopic examination
Key exclusion criteria
Person who take a medicine, have a previous experience of bad feeling from music and indirect lighting, and have a previous abdominal surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Okahisa |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of General Medicine and Community Health Science
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima city
TEL
088-633-7124
okahisa5505@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Sogabe |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of General Medicine and Community Health Science
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima city
TEL
088-633-7124
Homepage URL
sogabe.masahiro@tokushima-u.ac.jp
Sponsor or person
Institute
Shikoku Central Hospital of the Mutual aid Association of Public School teachers
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038399
