UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021926
Receipt number R000025284
Scientific Title A experimental study on assessing of death education.
Date of disclosure of the study information 2016/04/15
Last modified on 2018/10/17 15:37:30

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Basic information

Public title

A experimental study on assessing of death education.

Acronym

A experimental study on assessing of death education.

Scientific Title

A experimental study on assessing of death education.

Scientific Title:Acronym

A experimental study on assessing of death education.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to iongitudinally assess the effects of a death education program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Death anxiety scale.
Death perspective scale.
Heart rate variability.
Brain wave.
Saliva amylase activity.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Interventions/Think about their own death

Interventions/Control_2

Interventions/Think about the death of important others

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

A person who has severe heart disease, high blood pressure, a moderate or severe cognitive dysfunction.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yumi Kono

Organization

Kio University

Division name

Faculty of health science

Zip code


Address

4-2-2Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Email

y.kono@kio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yumi Kono

Organization

Kio University

Division name

Faculty of health science

Zip code


Address

4-2-2Umami-naka Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN

TEL

0745-54-1601

Homepage URL


Email

y.kono@kio.ac.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 04 Month 15 Day


Related information

URL releasing protocol


Publication of results

Published


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 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 15 Day

Last modified on

2018 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025284


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name