UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038755
Receipt number R000044183
Scientific Title Feasibility of Mindfulness Web Application for Nurses: Pilot Study
Date of disclosure of the study information 2020/01/07
Last modified on 2020/12/15 13:23:58

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Basic information

Public title

Mindfulness Web Application for Nurses

Acronym

Mindfulness Web App for Nurses

Scientific Title

Feasibility of Mindfulness Web Application
for Nurses: Pilot Study

Scientific Title:Acronym

Mindfulness Web App for nurses: Pilot Study

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the feasibility of the mindfulness Web Application that was developed to improve nurses' well being.

Basic objectives2

Others

Basic objectives -Others

feasibility

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Effects of nurses'perceptions including well-being, burnout, coping, and social support.

Key secondary outcomes

The situation of utilization of the web application


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Participants will have the web-application for 1 month. They will be asked to take an online survey before starting the application, 2 weeks, 4 weeks and 6 weeks after starting the application. This application is for mindfulness training including meditation and Yoga.

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

Nurses currently working as a nurse

Key exclusion criteria

Nurses who are not working

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Riko
Middle name
Last name Sano

Organization

Gifu University of Medical Science

Division name

Nursing

Zip code

509-0261

Address

4-3-3 Nijigaoka Kani, Gifu Japan 509-0261

TEL

0574-65-6555

Email

rsano@u-gifu-ms.ac.jp


Public contact

Name of contact person

1st name Riko
Middle name
Last name Sano

Organization

Gifu University of Medical Science

Division name

Nursing

Zip code

509-0261

Address

4-3-3 Nijigaoka Kani, Gifu Japan 509-0261

TEL

0574-65-6555

Homepage URL


Email

rsano@u-gifu-ms.ac.jp


Sponsor or person

Institute

Gifu University of Medical Science
Nursing

Institute

Department

Personal name



Funding Source

Organization

Gifu University of Medical Science
Nursing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu University of Medical Science

Address

4-3-3 Nijigaoka Kani, Gifu Japan 509-0261

Tel

0574-65-6555

Email

rsano@u-gifu-ms.ac.jp


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

2020 Year 01 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

13

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

Preinitiation

Date of protocol fixation

2020 Year 01 Month 13 Day

Date of IRB

2020 Year 01 Month 09 Day

Anticipated trial start date

2020 Year 01 Month 13 Day

Last follow-up date

2020 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 12 Month 02 Day

Last modified on

2020 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name