UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059031 |
|---|---|
| Receipt number | R000067522 |
| Scientific Title | Verification of the Effectiveness of VR Training Using the New STAI and Heart Rate Variability Analysis: Focusing on Newly Assigned Child Welfare Support Workers |
| Date of disclosure of the study information | 2025/09/15 |
| Last modified on | 2025/09/09 11:36:23 |
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Basic information
Public title
Verification of the Effectiveness of VR Training Using the New STAI and Heart Rate Variability Analysis
Focusing on Newly Assigned Child Welfare Support Workers
Acronym
A Study on VR Training and Stress Measurement for New Child Support Staff
Scientific Title
Verification of the Effectiveness of VR Training Using the New STAI and Heart Rate Variability Analysis: Focusing on Newly Assigned Child Welfare Support Workers
Scientific Title:Acronym
VR-STAI-HRV Training and Research
Region
| Japan |
Condition
Condition
No relevant disease (study involving healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targeted newly assigned staff members (including new graduates) at Child and Family Support Centers. It aimed to examine the effectiveness of Virtual Reality Role-Playing (VRRP) training, designed for parent interactions, by assessing subjective indicators using the revised STAI and physiological indicators through heart rate variability analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in State Anxiety and Trait Anxiety Scores Using the New STAI Version
Key secondary outcomes
Changes in Autonomic Nervous System Activity via Heart Rate Variability Analysis (HR, LF/HF, HF)
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention Name: VR-Based Interview Training (for Child Welfare Support Workers)
Intervention Period: 2 weeks
Intervention Sessions/Frequency: Total of 3 sessions (1-2 sessions per week, completed within 2 weeks)
Session Duration (Time Required): Total 60 minutes per session
VR Roleplay: 40 minutes (2 scenarios x 20 minutes each: Initial Interview/Crisis Intervention)
Debriefing: 20 minutes (Instructor feedback and summary)
Total Intervention Duration: 180 minutes total (120 minutes VR exposure + 60 minutes debriefing)
Equipment & Dose:
Standalone HMD (e.g., 6DoF, refresh rate 60-90Hz, display brightness at standard settings, no additional radiation exposure)
Controller or hand-tracking operation
Heart rate variability (HRV) measurement device: chest belt type or medical-grade ECG equivalent (sampling rate >= 250 Hz recommended)
Assessment Timepoints:
STAI (State-Trait Anxiety Inventory): baseline (pre-intervention), immediately after each session (primary outcome at final session), and 1-month follow-up
HRV (HR, HF, LF/HF): 5 minutes rest (seated), continuous recording during each VR scenario, and 3 minutes recovery (seated)
Safety Management/Discontinuation Criteria:
Immediate discontinuation if strong discomfort occurs during HMD use (e.g., dizziness, nausea, motion sickness, eye strain, severe anxiety, or palpitations); rest for 10-15 minutes, if not improved discontinue the session
Discontinue if HR increases abruptly compared to baseline (e.g., +40 bpm or more) with symptoms
Postpone session in case of illness or fever on the intervention day
Blinding:
Participants and instructors are not blinded
Outcome assessors (STAI scoring and HRV analysis) are blinded to group allocation (single blind)
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Population: Newly assigned child guidance/support workers at child guidance centers or equivalent agencies
2. Time since assignment: Within 12 months at enrollment
3. Age: 20 years or older
4. Employment: Employed on a continuous basis (full-time or part-time)
5. Language: Able to understand and respond in Japanese
6. Availability: Able to attend all intervention sessions (e.g., 3 sessions over 2 weeks) and the 1-month follow-up
7. Assessments: Willing and able to complete STAI and HRV measurements (HR, HF, LF/HF) with ECG or chest belt device
8. Device tolerance: No impediment to wearing or using a VR HMD
9. Consent: Provides written informed consent after receiving study explanations
Key exclusion criteria
1. Physical conditions
Severe cardiovascular disease, arrhythmia, epilepsy, or severe respiratory illness that may interfere with VR training or HRV measurement
Severe uncorrected visual or auditory impairment preventing the use of VR materials
2. VR-related limitations
History of severe VR sickness or motion sickness making continuation of training difficult
Head/neck disorders preventing safe use of head-mounted display (HMD)
3. Mental health conditions
Acute phase of psychiatric disorder where participation may worsen symptoms
Deemed inappropriate for participation by the investigator for safety or study validity reasons
4. Pregnancy / health status
Pregnant women with severe morning sickness or unstable health condition
Acute illness (fever, fatigue) on the day of training preventing safe participation
5. Participation conditions
Unable or unwilling to provide written informed consent
Unable to attend all scheduled intervention sessions or follow-up
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | miyagawa |
| Middle name | |
| Last name | tetsuya |
Organization
Tokyo City University
Division name
Department of Human Sciences, Faculty of Human Sciences
Zip code
1588557
Address
1-28-1 Tamazutsumi, Setagaya-ku, Tokyo
TEL
0357070104
dogtown0309@gmail.com
Public contact
Name of contact person
| 1st name | miyagawa |
| Middle name | |
| Last name | tetsuya |
Organization
Tokyo City University
Division name
Department of Human Sciences, Faculty of Human Sciences
Zip code
1588557
Address
1-28-1 Tamazutsumi, Setagaya-ku, Tokyo
TEL
0357070104
Homepage URL
dogtown0309@gmail.com
Sponsor or person
Institute
Tokyo City University
Institute
Department
Personal name
Funding Source
Organization
Tokyo City 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
Tokyo City University
Address
1-28-1 Tamazutsumi, Setagaya-ku, Tokyo
Tel
0357070104
dogtown0309@gmail.com
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 | 09 | Month | 15 | 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
11
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 10 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067522
