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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038755
Receipt No. 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

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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
Institute Gifu University of Medical Science
Nursing
Institute
Department

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
URL(English) https://upload.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


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