Clinical Trial: Verification of the Effectiveness of VR Training Using the New STAI and Heart Rate Variability Analysis: Focusing on Newly Assigned Child Welfare Support Workers (Japan)

Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059031) titled 'Verification of the Effectiveness of VR Training Using the New STAI and Heart Rate Variability Analysis Focusing on Newly Assigned Child Welfare Support Workers' on Sept. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tokyo City University

Condition: Condition - No relevant disease (study involving healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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)

Eligibility: Age-lower limit - 22 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 Size - 11

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067522

Disclaimer: Curated by HT Syndication.