UMIN-CTR Clinical Trial

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
Email	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
Email	mebi@aichi-med-u.ac.jp

Sponsor
Institute	Aichi medical university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047448