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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028793
Receipt No. R000032952
Scientific Title A study of the influence of the indirect lighting stimulation before endoscopic examination
Date of disclosure of the study information 2017/09/01
Last modified on 2017/10/18

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Basic information
Public title A study of the influence of the indirect lighting stimulation before endoscopic examination
Acronym A study of the influence of the indirect lighting stimulation before endoscopic examination
Scientific Title A study of the influence of the indirect lighting stimulation before endoscopic examination
Scientific Title:Acronym A study of the influence of the indirect lighting stimulation before endoscopic examination
Region
Japan

Condition
Condition Subject who undergo a endoscopic examination
Classification by specialty
Gastroenterology Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of the influence of the indirect lighting stimulation before 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 after stimulation of the indirect lighting
Key secondary outcomes 1. Tolerance and psychological condition
2. Blood pressure, pulse rate, and autonomic nervous function during and after endoscopic examination

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is 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 in the private room that is lighted up with indirect lighting before endoscopic examination
Interventions/Control_2 listening to the music on the sofa for ten minutes in the private room before endoscopic examination
Interventions/Control_3 listening to the music on the sofa for ten minutes in the private room that is lighted up with indirect lighting before endoscopic examination
Interventions/Control_4 Control: sitting on the sofa for ten minutes in the private room before 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 Subject who undergo a gastrointestinal endoscopic examination
Key exclusion criteria Persons who take a medicine, have a past history of bad feeling by audio or indirect lighting, and have a past history of abdominal surgery
Target sample size 120

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 Japan Mutual Aid Association of Public School Teachers
Organization
Division
Category of Funding Organization Other
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
2017 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032952

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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