UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059448 |
|---|---|
| Receipt number | R000067936 |
| Scientific Title | A Study on the Stress-Relieving Effects of Green VR Environments: A Volunteer Study |
| Date of disclosure of the study information | 2025/10/18 |
| Last modified on | 2025/10/18 12:15:04 |
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Basic information
Public title
A Study on the Stress-Relieving Effects of Green VR Environments: A Volunteer Study
Acronym
A Study on the Stress-Relieving Effects of Green VR Environments
Scientific Title
A Study on the Stress-Relieving Effects of Green VR Environments: A Volunteer Study
Scientific Title:Acronym
A Study on the Stress-Relieving Effects of Green VR Environments
Region
| Japan |
Condition
Condition
Dental Anesthesiology
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previously, VR incorporating green hues has demonstrated the potential to suppress the hypothalamic-pituitary-adrenal (HPA) axis and reduce stress. Activation of the HPA axis leads to cortisol secretion. Cortisol increases sensitivity to vasoconstrictors (such as noradrenaline and angiotensin II) and elevates peripheral vascular resistance by suppressing the production of vasodilators like nitric oxide (NO). Therefore, this study hypothesises that VR incorporating green may suppress cortisol production and thereby inhibit peripheral vascular resistance, leading to the implementation of the research described below.
Basic objectives2
Others
Basic objectives -Others
Developing a novel approach to manage and reduce stress and anxiety in patients with dental phobia using virtual reality (VR) technology.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Measurement of biochemical stress markers (minimally invasive): Saliva samples are collected from subjects before and after the VR experience. Using the SOMA CUBE Reader, concentrations of salivary cortisol, secretory immunoglobulin A (sIgA), secretory immunoglobulin G (sIgG), and amylase are measured. Changes in these biomarkers will be analysed to evaluate alterations in stress responses and immune responses following VR intervention.
2) Measurement of peripheral vascular resistance (non-invasive): Using the WatchPad 300, changes in peripheral vascular resistance will be continuously measured before, during, and after the VR experience. Additionally, non-invasive continuous estimated cardiac output (esCCO) will be used to continuously measure changes in cardiac output (esCCO) before, during, and after the VR experience. Pulse wave transmission time (PWTT), an indicator of peripheral vasoconstriction, will also be calculated. These measurements will quantify the effects of the green VR environment on cardiac function and vascular tone.
3) Heart rate variability analysis (non-invasive): Using my Beat, record and analyse heart rate variability (HRV) before, during, and after the VR experience to evaluate changes in sympathetic/parasympathetic balance. Objectively assess the impact of VR intervention on the autonomic nervous system through fluctuations in HRV parameters (e.g., LF/HF ratio).
4) Tissue blood flow and oxygenation measurement (non-invasive): Using NIRO200nx, continuously measure changes in cerebral blood flow and oxygenation before, during, and after the VR experience. Record changes in blood flow dynamics in the prefrontal cortex due to green VR exposure from variations in tissue oxygenation index (TOI) and tissue haemoglobin index (nTHI), and evaluate the impact on the central nervous system in the stress response.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
This study is a cohort study involving stress loading on the same subjects, with measurements of each parameter taken before and after exposure to a green VR environment.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults (American Society of Anesthesiologists physical status classification (ASA-PS classification of 1 or 2))
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | HIDETAKA |
| Middle name | |
| Last name | KURODA |
Organization
KANAGAWA DENTAL UNIVERSITY
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
0468228751
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | HIDETAKA |
| Middle name | |
| Last name | KURODA |
Organization
KANAGAWA DENTAL UNIVERSITY
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
0468228751
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
KANAGAWA DENTAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
None
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
KANAGAWA DENTAL UNIVERSITY INSTITUTIONAL REVIEW BOARD
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
Tel
0468228751
kenkyo@kdu.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
| 2025 | Year | 10 | Month | 18 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067936
