UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034686 |
|---|---|
| Receipt number | R000039262 |
| Scientific Title | 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 10:48:08 |
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Basic information
Public title
Relationship between heart rate variability biofeedback and resilience in nursing students
Acronym
Relationship between heart rate variability biofeedback and resilience
Scientific Title
Relationship between heart rate variability biofeedback and resilience in nursing students
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Momoe Utsumi |
Organization
Osaka University
Division name
Graduate school of medicine, Division of Health Sciences
Zip code
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2523
utsumi@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Momoe Utsumi |
Organization
Osaka University
Division name
Graduate school of medicine, Division of Health Sciences
Zip code
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-2523
Homepage URL
utsumi@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 29 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039262
