UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation research of stress relieving effect on optimization environmental of a high-resolution sound source in university hospital.
Title of the study (Brief title)	Investigation of stress relieving effect of a high-resolution sound source.
Region	Japan

Condition
Condition	Not specified
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the change of satisfaction with placing the system of hyper resolution sound at the outpatient waiting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Questionnaire of satisfaction
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) more than 20 years old 2) no difficulty of reading and writing 3) subjects who accept the answer
Key exclusion criteria	Refer to inclusion criteria
Target sample size	200

Research contact person
Name of lead principal investigator	Toshinori Ito
Organization	Osaka University School of Medicine
Division name	Department of Integrative Medicine
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3498
Email	a-yasueda@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Asuka Yasueda
Organization	Osaka University School of Medicine
Division name	Department of Integrative Medicine
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3498
Homepage URL
Email	a-yasueda@cam.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University School of Medicine Department of Integrative Medicine
Institute
Department

Funding Source
Organization	None
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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2015 Year 12 Month 15 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluate the change of patient's satisfaction whether with or without system of high resolution sound source Study design: cross sectional method Recruit method: Patients who come to ophthalmology of our hospital in 16-20th November or 14-18th December. Subjects: Patients who accept to answer the survey and meet our inclusion criteria. Evaluation Item: survey of satisfaction rate of our hospital.

Management information
Registered date	2015 Year 11 Month 09 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022590