UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020867
Receipt number R000024080
Scientific Title Motion Anime DVD Intervention for Japanese Nurses: a Mixed Method Study
Date of disclosure of the study information 2016/02/03
Last modified on 2019/02/05 17:34:27

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Basic information

Public title

Motion Anime DVD Intervention for Japanese Nurses: a Mixed Method Study

Acronym

Motion Anime DVD Intervention for Japanese Nurses

Scientific Title

Motion Anime DVD Intervention for Japanese Nurses: a Mixed Method Study

Scientific Title:Acronym

Motion Anime DVD Intervention for Japanese Nurses

Region

Japan


Condition

Condition

Healthy Japanese nurses

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 Japanese nurses who are taking care of 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

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Primary outcomes will be measured by immiediately after the digital animation intervention. It will be Apri, 2016;(1) Mari meter-X for reducing anxiety for health promotion and health system in Japan, (2) STAI-Y (Japanese) for reducing emotional anxiety, (3) Measuring enjoyment by a face scale.

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

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Behavior,custom 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: 2016.3.1-2016.3.15, 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: 2016.1.27-2016.2.5, 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

21 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

Nurses who are currently work and willing to participant this research at A hospital in Kobe Japan.

Key exclusion criteria

Nurses who are currently work, but not willing to participant this research at A hospital in Kobe Japan.

Target sample size

240


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(0)562-38-7114

Email

mn378@nyu.edu


Public contact

Name of contact person

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(0)562-38-7114

Homepage URL


Email

mn378@nyu.edu


Sponsor or person

Institute

Nursing Department
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

A病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 03 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

Completed

Date of protocol fixation

2016 Year 02 Month 04 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 04 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 03 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=R000024080


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name