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

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 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


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

Value
https://center6.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