UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059704 |
|---|---|
| Receipt number | R000068285 |
| Scientific Title | The Effectiveness of Virtual Reality in Reducing Perioperative Anxiety Among Oral Surgery Patients: A Salivary Biomarker and Questionnaire-Based Study |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/08 21:02:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Using Virtual Reality to Help Reduce Anxiety Before Oral Surgery
Acronym
VR-RELAX
Scientific Title
The Effectiveness of Virtual Reality in Reducing Perioperative Anxiety Among Oral Surgery Patients: A Salivary Biomarker and Questionnaire-Based Study
Scientific Title:Acronym
RELAX-VR
Reducing perioperative anxiety using salivary biomarker analysis and Virtual Reality
Region
| Asia(except Japan) |
Condition
Condition
Preoperative anxiety in oral surgery patients
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effectiveness of virtual reality in reducing preoperative anxiety among patients undergoing minor oral surgery. This will be assessed using changes in salivary alpha-amylase and cortisol levels, as well as the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in salivary alpha-amylase, salivary cortisol levels, and APAIS scores from pre- to post-intervention to assess perioperative anxiety reduction.
Key secondary outcomes
Patient satisfaction score with preoperative experience
Definition: Self-reported satisfaction with the preoperative process, including comfort and clarity of information.
Time point: Immediately after intervention (after VR or control exposure but before surgery).
Instrument: 5-point Likert scale questionnaire (1 = very dissatisfied, 5 = very satisfied).
Change in heart rate as a physiological marker of anxiety
Definition: Difference in heart rate measured before and after intervention.
Time point: Measured immediately before and after VR or control exposure.
Unit: Beats per minute (bpm).
Method: Digital pulse oximeter.
Incidence of adverse events during VR use
Definition: Frequency of nausea, dizziness, or other discomfort during or after VR exposure.
Time point: During and immediately after VR session.
Method: Structured observation checklist and spontaneous reporting.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Virtual Reality Relaxation
Participants in the intervention group received a 15-minute immersive Virtual Reality (VR) session immediately prior to minor oral surgery under general anesthesia. The VR content featured a relaxing beach environment with calming background sounds. The session was delivered using a head-mounted display (Oculus Go), with the same video and duration used for all participants to ensure standardization.
Duratioin 15 minutes, one-time session
Interventions/Control_2
Standard Preoperative Procedure (Control Group)
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
| 18 | years-old | < |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 to 45 years
Scheduled for elective minor oral surgery under general anesthesia
Able to understand the study procedures and provide informed consent
Able to read and complete the APAIS questionnaire
No prior exposure to virtual reality
Key exclusion criteria
History of psychiatric or neurological disorders
Use of medications affecting stress hormones in the last 7 days (e.g., corticosteroids, anxiolytics)
Systemic diseases that may affect saliva biomarkers (e.g., diabetes, adrenal disorders)
Current or past substance abuse (alcohol, drugs)
Pregnant or breastfeeding
Visual, vestibular, or balance disorders that interfere with VR usage
Allergy to materials used for saliva collection
Unwilling or unable to comply with study procedures
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Abel |
| Middle name | Tasman |
| Last name | Yuza |
Organization
Universitas Padjadjaran
Division name
Faculty of Dentistry
Zip code
40132
Address
Jalan Sekeloa Selatan i Bandung
TEL
62817212232
abel.yuza@unpad.ac.id
Public contact
Name of contact person
| 1st name | Arlette |
| Middle name | Suzy |
| Last name | Setiawan |
Organization
Universitas Padjadjaran
Division name
Faculty of Dentistry
Zip code
40132
Address
Jl. Sekeloa Selatan I Bandung
TEL
628122092334
Homepage URL
arlette.puspa@unpad.ac.id
Sponsor or person
Institute
Universitas Padjadjaran
Institute
Department
Personal name
Universitas Padjadjaran
Funding Source
Organization
Universitas Padjadjaran
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Dentistry, Universitas Padjadjaran
Address
Jalan Sekeloa Selatan I
Tel
6222
fkg@unpad.ac.id
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
Rumah Sakit Gigi dan Mulut Unpad
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 10 | 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
30
Results
A total of 30 participants were randomized equally into VR and control groups. Both groups showed significant reductions in salivary alpha-amylase and APAIS scores post-intervention. No significant between-group differences were observed in cortisol levels. The VR group showed a larger reduction in anxiety biomarkers and questionnaire scores, suggesting VR may be effective in reducing perioperative anxiety.
Results date posted
| 2025 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 30 participants were enrolled in the study and randomly allocated into the Virtual Reality (VR) group and the control group, with 15 participants in each. Baseline characteristics including age, sex, and educational background were comparable between the two groups, indicating successful randomization.
Participant flow
Out of 45 patients assessed for eligibility, 30 participants met the inclusion criteria and were randomized into two groups: 15 in the Virtual Reality (VR) group and 15 in the control group. All participants received the allocated intervention and completed the study, with no loss to follow-up or discontinuation.
Adverse events
No adverse events or complications were reported in either the Virtual Reality (VR) or control group throughout the study period. All participants completed the intervention without experiencing dizziness, nausea, discomfort, or exacerbation of anxiety symptoms during or after the intervention. The procedure and data collection process were well tolerated by all participants.
Outcome measures
Primary Outcome
Name: Change in preoperative anxiety levels
Measurement Tool: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Timepoint: Before and after the intervention (immediately after VR exposure and before surgery)
Description: APAIS scores will be compared between the VR intervention group and the control group to determine effectiveness in reducing preoperative anxiety.
Key Secondary Outcomes
Name: Salivary alpha-amylase concentration
Measurement Tool: Saliva test using ELISA method
Timepoint: Before and after VR intervention
Description: Measures sympathetic nervous system activity associated with stress.
Name: Salivary cortisol concentration
Measurement Tool: Saliva test using ELISA method
Timepoint: Before and after VR intervention
Description: Measures hypothalamic-pituitary-adrenal (HPA) axis activity to assess physiological stress response.
Plan to share IPD
Plan to share IPD: No
IPD sharing Plan description
Justification:
The individual participant data (IPD) will not be shared publicly due to privacy concerns and ethical considerations related to identifiable salivary biomarkers and anxiety questionnaires.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068285
