UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054775 |
|---|---|
| Receipt number | R000062597 |
| Scientific Title | Examination of the Effect of Viewing VR Natural Environments on Depression Reduction |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/06/26 13:22:17 |
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Basic information
Public title
The Effect of Viewing VR Natural Environments on Reducing Depression
Acronym
VR Natural Environments Depression Reduction (VR-NEDR)
Scientific Title
Examination of the Effect of Viewing VR Natural Environments on Depression Reduction
Scientific Title:Acronym
VR Natural Environments Depression Reduction Examination (VR-NEDRE)
Region
| Japan |
Condition
Condition
Depressive Symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of VR videos depicting natural environments on participants' depressive symptoms. Using a head-mounted display, 360-degree videos of natural environments will be provided, and changes in depressive symptoms will be quantitatively measured using the POMS2 (Profile of Mood States 2) scale. Additionally, participants will be categorized into low and high depression groups based on initial screening with POMS2, and the effects of the VR intervention will be compared between these groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in depressive symptoms: Measure the change in depression-dejection scale scores resulting from viewing 360-degree videos of natural environments provided through a head-mounted display (POMS2).
Key secondary outcomes
Analysis of order effects: Analyze the differences in behavioral and physiological responses by having participants view videos of natural and urban environments in different sequences.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants will first view VR videos of natural environments, followed by VR videos of urban environments. Each video will be viewed for 10 minutes, with a 5-minute break in between.
Interventions/Control_2
Participants will first view VR videos of urban environments, followed by VR videos of natural environments. Each video will be viewed for 10 minutes, with a 5-minute break in between. After viewing, the change in depression scores will be assessed using the POMS2.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults in their twenties who have the cognitive ability to understand the consent form and voluntarily express their consent.
Key exclusion criteria
Individuals currently taking antidepressants or undergoing other psychiatric interventions.
Individuals with medical or psychological conditions that make the use of VR devices inappropriate (e.g., epilepsy, severe eye disorders, conditions causing severe dizziness).
Individuals who have experienced severe motion sickness or psychological trauma from previous VR use.
Individuals with known allergic reactions or extreme fear toward the planned VR content.
Individuals who have difficulty communicating in Japanese.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Orihashi |
Organization
Kochi University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
783-8505
Address
185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi, 783-8505, Japan
TEL
088-866-5811
orihashik@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Kawakubo |
Organization
Kochi University
Division name
Medical Student
Zip code
771-1507
Address
116 Kawakubo, Yoshida, Donari-cho, Awa-shi, Tokushima, Japan
TEL
090-8286-0649
Homepage URL
ryou.k.1144@icloud.com
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi 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
Kochi University Ethics Committee
Address
185-1 Kohasu, Oko-cho, Nankoku-shi, Kochi, 783-8505, Japan
Tel
088-880-2180
is21@kochi-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
| 2024 | Year | 09 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062597
