UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015023
Receipt number 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 17:36:41

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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 or person

Institute

Univeristy of Human Environments

Institute

Department

Personal name



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

Value
https://center6.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