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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033681
Receipt No. 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

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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
Email 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
Email sogabe.masahiro@tokushima-u.ac.jp

Sponsor
Institute Shikoku Central Hospital of the Mutual aid Association of Public School teachers
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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