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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034686
Receipt No. R000039262
Official scientific title of the study Relationship between heart rate variability biofeedback and resilience in nursing students
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/02

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Basic information
Official scientific title of the study Relationship between heart rate variability biofeedback and resilience in nursing students
Title of the study (Brief title) Relationship between heart rate variability biofeedback and resilience
Region
Japan

Condition
Condition Nursing students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify whether heart rate variability biofeedback improves resilience
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sukemune-Hiew Resilience Test
Key secondary outcomes OSA sleep inventory MA version, time of sleeping, HRV-BF implementation status, VAS scale (fatigue feeling, comfortable feeling, drowsiness)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Heart rate variability biofeedback training
5-20minutes per day
Interventions/Control_2 No intervention
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 Female
Key inclusion criteria A student enrolled at Osaka University or Osaka University graduate school and majored in nursing studies
Key exclusion criteria Those who regularly take medicine
Target sample size 44

Research contact person
Name of lead principal investigator Momoe Utsumi
Organization Osaka University
Division name Graduate school of medicine, Division of Health Sciences
Address 1-7 Yamadaoka, Suita, Osaka
TEL 06-6879-2523
Email utsumi@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person Momoe Utsumi
Organization Osaka University
Division name Graduate school of medicine, Division of Health Sciences
Address 1-7 Yamadaoka, Suita, Osaka
TEL 06-6879-2523
Homepage URL
Email utsumi@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 29 Day
Anticipated trial start date
2018 Year 11 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 29 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039262

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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