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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015023
Receipt No. R000017471
Scientific Title Providing Japanese Health Care Information for Foreign Tourists: Digital Animation Intervention
Date of disclosure of the study information 2014/09/03
Last modified on 2019/02/05

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Basic information
Public title Providing Japanese Health Care Information for Foreign Tourists: Digital Animation Intervention
Acronym Digital Animation Intervention for Foreign Tourists
Scientific Title Providing Japanese Health Care Information for Foreign Tourists: Digital Animation Intervention
Scientific Title:Acronym Digital Animation Intervention for Foreign Tourists
Region
Japan

Condition
Condition Healthy Foreign Tourists
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of our study is to investigate the effectiveness of health promotion using digital animation media for foreign tourists in Japan.
Our hypotheses are; (1) decrease concerns about Japanese health promotion and health system, (2) decrease anxieties to visit Japanese health facilities, (3) enjoy watching a digital animation DVD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary outcomes will be measured by (1) Mari meter-X for health promotion and health system in Japan, (2) STAI-Y for reducing emotional anxiety, (3) a face scale for measuring enjoyment at a baseline and immediately after digital animation intervention.
Key secondary outcomes Key secondary outcomes will be measured by an open-end questionnaire at a baseline and immediately after the digital animation intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 A(-) B(-)
Interventions/Control_2 A(+) Intervention group:
Providing Japanese health care information through digital animation (3 minutes 50 seconds)
Time: 10 minutes
Period: 2014.9.24-2014.12.31, only once

B(-)



Interventions/Control_3 A(-)

B(+) Control Group (no intervention):
short Japanese health care information with paper hardcopy (1 minute)
Time: 7 minutes
Period: 2014.9.24-2014.12.31, only once

Interventions/Control_4 A(+) B(+)
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 Foreign tourists who are eligible to answer a questionnaire in English.

Foreign tourists who have been in Japan for less than three months.
Key exclusion criteria Foreign tourists whose are ineligible to answer the questionnaire in English.

Foreign tourists who have been in Japan for more than three months.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Nishikawa
Organization Univeristy of Human Environments
Division name Graduate School of Nursing
Zip code
Address 3-220, Ebata cho, Obu city, Aichi, 474-0035, Japan
TEL +81-562-43-0701
Email mn378@nyu.edu

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Nishikawa
Organization University of Human Environments
Division name Graduate School of Nursing
Zip code
Address 3-220, Ebata cho, Obu city, Aichi, 474-0035, Japan
TEL +81-562-43-0701
Homepage URL
Email mn378@nyu.edu

Sponsor
Institute Univeristy of Human Environments
Institute
Department

Funding Source
Organization Funding: Grant-in-Aid for Challenging Exploratory Research 2014.4-2017.3: Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 成田空港国際線ターミナル(千葉県)、広島「花宿」(広島県)
Narita International Airport (Chiba) & Hiroshima Hana Hostel (Hiroshima)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1186/s12913-018-3191-x
Number of participants that the trial has enrolled
Results
Watching a digital animation is more effective in reducing anxiety among international visitors to Japan compared with reading a standard brochure or guidebook. 
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 Completed
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017471

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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