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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041760 |
Receipt No. | R000047663 |
Scientific Title | The study of relationship between proficiency level and anxiety reduction effect in heart rate variability biofeedback training |
Date of disclosure of the study information | 2020/10/05 |
Last modified on | 2020/09/11 |
Basic information | ||
Public title | The study of relationship between proficiency level and anxiety reduction effect in the training with slow pace breathing | |
Acronym | The relationship between proficiency level and anxiety reduction effect in slow pace breathing training | |
Scientific Title | The study of relationship between proficiency level and anxiety reduction effect in heart rate variability biofeedback training | |
Scientific Title:Acronym | The relationship between proficiency level and anxiety reduction effect in heart rate variability biofeedback training | |
Region |
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Condition | ||
Condition | Healthy adult | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify that proficiency level is one of the factors contributing training effect in heart rate variability training by investigating dose-response relationship between the proficiency level and the anxiety reduction effect. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Changes of State Anxiety Scale scores (State-Trait Anxiety Inventory-JYZ) before and after heart rate variability biofeedback training
Proficiency level calculated by dedicated device for heart rate variability biofeedback training |
Key secondary outcomes | Heart rate variability |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | |
Blocking | YES |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Heart rate variability biofeedback training (15 minutes) | |
Interventions/Control_2 | Resting breathing (15 minutes) | |
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 |
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Age-upper limit |
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Gender | Male | |||
Key inclusion criteria | Healthy male students belonging to the Department of Health Sciences, School of Medicine or the Graduate School of Health Sciences, Hokkaido University | |||
Key exclusion criteria | 1) Persons with a history of brain disease or brain trauma
2) Persons with a history of cardiovascular / respiratory diseases 3) Persons with a history of mental illness 4) Persons who have experienced abnormal breathing in the past 5) Persons who are taking drugs that affect the autonomic nervous system |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido University | ||||||
Division name | Faculty of Health Sciences | ||||||
Zip code | 060-0812 | ||||||
Address | Nishi 5, Kita 12, Kita-ku, Sapporo, Hokkaido | ||||||
TEL | 011-706-3388 | ||||||
sakai@hs.hokudai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokkaido University | ||||||
Division name | Faculty of Health Sciences | ||||||
Zip code | 060-0812 | ||||||
Address | Nishi 5, Kita 12, Kita-ku, Sapporo, Hokkaido | ||||||
TEL | 011-706-3388 | ||||||
Homepage URL | |||||||
sakai@hs.hokudai.ac.jp |
Sponsor | |
Institute | Hokkaido University |
Institute | |
Department |
Funding Source | |
Organization | Hokkaido 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 | Ethical committee of Faculty of Health Sciences in Hokkaido University |
Address | Nishi 5, Kita 12, Kita-ku, Sapporo, Hokkaido |
Tel | 011-706-3316 |
shomu@hs.hokudai.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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047663 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |