UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051947 |
|---|---|
| Receipt number | R000059283 |
| Scientific Title | Factors Influencing the Relaxation Effect of VR on Postoperative Cardiovascular Surgery Patients and Their Interaction Effects |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/08/19 13:41:30 |
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Basic information
Public title
Factors Influencing the Relaxation Effects of Virtual Reality (VR) on Postoperative Cardiovascular Surgery Patients and Their Interaction Effects
Acronym
Factors Influencing the Relaxation Effects of Virtual Reality (VR) on Postoperative Cardiovascular Surgery Patients and Their Interaction Effects
Scientific Title
Factors Influencing the Relaxation Effect of VR on Postoperative Cardiovascular Surgery Patients and Their Interaction Effects
Scientific Title:Acronym
Factors Influencing the Relaxation Effect of VR on Postoperative Cardiovascular Surgery Patients and Their Interaction Effects
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiovascular surgery | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the most influential factor (main effect) of a VR intervention for relaxation (improvement of the autonomic nervous system and mental state) in patients after cardiovascular surgery by examining the interaction between the dimension of images, type of images, and whether or not exercise was used, using the full implementation factorial design in the experimental design method, and to identify the most effective factor (main effect). By examining the interactions among the factors of VR, it will be possible to clarify which of the aforementioned factors is more effective for relaxation, which will lead to better effects with minimal resources.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system (heart rate variability analysis): HF: High frequency, LF/HF: High frequency/Low Frequency
Key secondary outcomes
Profile of Mood States 2nd Edition (POMS2)
Simulator sickness questionnaire (SSQ)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Each subject will be assigned to each of the combinations obtained in the full implementation factorial design in the experimental design method. Each item will have two levels, and the three factors will be the dimension of the image (two-dimensional or three-dimensional), the type of image (places visited at least once or places not visited), and the ergometer (with or without ergometer). The diagnostic statistic D-efficiency, G-efficiency, and A-efficiency were set to be 100 each, and each of the 8 combinations was conducted 4 times, so there were 32 subjects in total.
Interventions1: Dimension = 3D, Image = not visited, Ergometer = none
Interventions/Control_2
Dimension = 3D, Video = not visited, Ergometer = use
Interventions/Control_3
Dimension = 3D, Image = Visited, Ergometer = None
Interventions/Control_4
Dimension = 3D, Image = Visited, Ergometer = use
Interventions/Control_5
Dimension = 2D, Image = Not visited, Ergometer = None
Interventions/Control_6
Dimension = 2D, Image = Not visited, Ergometer = use
Interventions/Control_7
Dimension = 2D, Image = Visited, Ergometer = None
Interventions/Control_8
Dimension = 2D, Image = Visited, Ergometer = use
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Persons for whom rehabilitation intervention has been performed
(ii) Aged 65 years or older at the time of consent.
(iii) Residents of Nagano Prefecture who have visited Matsumoto Castle before.
(iv) Patients who have undergone open heart surgery by a cardiovascular surgeon.
(v) Those who have scored 24 or more on the Mini-Mental State Examination -Japanese (MMSE-J).
(vi) Those who can use an ergometer for more than 10 minutes.
(vii) Subjects who have given a full explanation of their participation in this study and who have given written consent of their own free will.
Key exclusion criteria
(i) Those with psychiatric disorders (schizophrenia, dementia, etc.) accompanied by hallucinations or delusions.
(ii) Those with a history of depression
(iii) Those with severe visual or auditory impairment (diplopia, low vision due to macular degeneration, retinopathy, etc., severe low tone disorder, hearing loss), claustrophobia, etc., who have difficulty wearing VR
(iv) Those with arrhythmia such as atrial fibrillation, extrasystole, heart rate fragmentation, etc.
(v) Subjects who are prone to motion sickness
(vi) Other subjects who the principal investigator deems inappropriate as subjects.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Tsukakoshi |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-0802, Japan
TEL
08023463036
daichi226@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Tsukakoshi |
Organization
Shinshu University Hospital
Division name
Department of Rehabilitation
Zip code
3900802
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-0802, Japan
TEL
0263372836
Homepage URL
daichi226@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Hospital
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
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan
Tel
0263372572
mdrinri@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2023 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059283
