UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044283 |
|---|---|
| Receipt number | R000050529 |
| Scientific Title | Pilot study of evaluation of the auto-nervous system and psychological state when person perform the mind-fullness breathing method using VR (virtual reality) software. |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2022/06/07 17:18:59 |
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Basic information
Public title
Pilot study of evaluation of the auto-nervous system and psychological state when person perform the breathing method using VR (virtual reality) software.
Acronym
Examination of the breathing method using VR.
Scientific Title
Pilot study of evaluation of the auto-nervous system and psychological state when person perform the mind-fullness breathing method using VR (virtual reality) software.
Scientific Title:Acronym
Examination of the breathing method using VR
Region
| Japan |
Condition
Condition
Chronic pain patients who included a healthy
Classification by specialty
| Psychiatry | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the breathing method by using VR on auto-nervous system and psychological state in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase of parasympathetic nervous system during and after viewing VR.
Key secondary outcomes
1. Increase of autonomic nervous system activity during and after viewing VR.
2. Psychological sides
The increase of the positive item or decrease of the negative item on PANAS 20Question(Positive and Negative Affect Schedule).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Measurement of autonomic nerveous system and psychological state during and after viewing VR software.
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
Healthy adult
Key exclusion criteria
The person whom even following any one fits
*visual impairment
*hearing impairment
*acrophobia
*claustrophobia
*severely mental disorder that treatment needs
*with a history of epileptic stroke
*during menstruation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shie |
| Middle name | |
| Last name | Kamijo |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science Department of Medical Welfare
Zip code
513-0293
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
TEL
059-383-8991
s-kamijo@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shie |
| Middle name | |
| Last name | Kamijo |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science Department of Medical Welfare
Zip code
510-0293
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
TEL
+81-59-383-9208(ext.2421)
Homepage URL
s-kamijo@suzuka-u.ac.jp
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suzuka University of Medical Science the ethics committees of clinical researches
Address
1001-1 Kishioka-cho, Suzuka-city, Mie 513-0293
Tel
+81-59-383-9208(ext.2421)
s-kamijo@suzuka-u.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
鈴鹿医療科学大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 28 | 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
17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult 17
Gender
Male 7
Female 10
Age
20-24 15
25-29 2
Employment
Student 11
Graduate student 5
Housewife 1
Virtual reality experience
None at all 14
A little 3
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050529
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
