UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the influence of the indirect lighting stimulation before endoscopic examination
Title of the study (Brief title)	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	Toshiya Okahisa
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of General Medicine and Community Health Science
Address	3-18-15 Kuramoto-cho, Tokushima city
TEL	088-633-7124
Email	okahisa5505@tokushima-u.ac.jp

Public contact
Name of contact person	Masahiro Sogabe
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of General Medicine and Community Health Science
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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