UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
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	Device,equipment
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	20 years-old <=
Age-upper limit	30 years-old >
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
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Sakai
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
Email	sakai@hs.hokudai.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Sakai
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
Email	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
Email	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	2020 Year 10 Month 05 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	45
Results	The correlation analysis revealed no significant correlation between the proficiency level and the change in state anxiety score in either the heart rate variability biofeedback training (r = -0.18, P = 0.365) or control groups (r = 0.27, P = 0.295). Regression analysis revealed no significant linear relationship between the proficiency level and the change in state anxiety score in either the heart rate variability biofeedback training (R^2 = 0.03, P =0.365) or control groups (R^2 = 0.07, P = 0.295).
Results date posted	2021 Year 08 Month 04 Day
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	Completed
Date of protocol fixation	2020 Year 09 Month 11 Day
Date of IRB	2020 Year 10 Month 09 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 11 Day
Last modified on	2021 Year 08 Month 04 Day

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

Contact us.