UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060459 |
|---|---|
| Receipt number | R000063811 |
| Scientific Title | Evaluation of the impact of virtual operating room visits using virtual reality (VR) on reducing patient anxiety |
| Date of disclosure of the study information | 2026/01/25 |
| Last modified on | 2026/01/25 02:04:12 |
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Basic information
Public title
The impact of virtual operating room visits using VR on reducing patient anxiety
Acronym
Reducing anxiety through virtual operating room visits Using VR
Scientific Title
Evaluation of the impact of virtual operating room visits using virtual reality (VR) on reducing patient anxiety
Scientific Title:Acronym
The impact of virtual operating room visits using VR on reducing anxiety
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients preparing for surgery experience a great deal of anxiety and stress before the procedure. In addition to anxiety about the surgery itself, the stress of being in an unfamiliar environment is significant. The aim of this study is to investigate whether it is possible to reduce anxiety and stress by simulating a visit to the operating room using VR prior to surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in fear and anxiety (VAS) before and after viewing VR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
VR viewing
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the Department of Oral and Maxillofacial Surgery at Saga University, scheduled for surgery under general anesthesia in the central operating room, and who have given consent to participate in this study.
Key exclusion criteria
(1) Patients under 15 years old or over 80 years old.
(2) Pregnant patients.
(3) Patients with a history of epilepsy.
(4) Patients with claustrophobia.
(5) Patients with a history of mood disorders caused by viewing VR in the past (cyber patients) or patients with vertigo.
(6) Patients with heart disease.
(7) Patients with conditions such as dementia, intellectual disability, post-traumatic stress disorder (PTSD), or psychiatric disorders.
(8) Other patients deemed inappropriate by the investigator.
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City
TEL
0952342397
yamashy2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Reona |
| Middle name | |
| Last name | Aijima |
Organization
Saga University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga City
TEL
0952342397
Homepage URL
f8197@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga 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
Clinical Research Center, Saga University Hospital
Address
849-8501 5-1-1 Nabeshima, Saga City
Tel
0952343400
kenkyu-shinsei@ml.cc.saga-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
| 2026 | Year | 01 | Month | 25 | 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
41
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
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063811
