Efficacy and Safety of Virtual Reality-Based Versus Traditional Emotion-to-Emotion Therapy for Treatment of Hwa-Byung: A Protocol for a Single-Center, Randomized, Assessor-Blind, Parallel-Group Clinical Trial.

Background: Hwa-Byung is a culturally bound syndrome prevalent in Korea, characterized by intense emotional distress and physical symptoms related to suppressed anger. Patients frequently report experiencing chest tightness, heat sensations, and globus pharyngeus (the sensation of a lump in the throat). These physical symptoms often accompany psychological distress and can exacerbate the sense of frustration and helplessness associated with the condition. The distinctive presentation of these symptoms highlights the necessity for therapeutic interventions that address both the emotional and physical aspects of Hwa-Byung. Conventional therapeutic methods, such as Emotion-to-Emotion Therapy (ETE), have shown efficacy in treating this condition. This study aims to assess the efficacy of Virtual Reality-based Emotion-to-Emotion Therapy (VR-based ETE) compared to conventional ETE, utilizing immersive digital platforms to enhance therapeutic engagement.

Methods: This single-center, randomized, assessor-blind, parallel-group clinical trial will enroll 96 participants, evenly divided into two experimental groups and one control group. Over eight weeks, each participant will undergo 12 intervention sessions. Experimental group 1 will receive conventional ETE, experimental group 2 will receive VR-based ETE, and the control group will receive Hwa-Byung management training materials. The primary outcome will be the change in symptoms, measured by the Likert Scale for Major Symptoms of Hwa-Byung from baseline to 8 weeks. Secondary outcomes will include psychometric scales and physiological measures such as the core seven-emotions inventory short form, physical health questionnaire, stress response index, Beck depression inventory, state-trait anger expression inventory, state-trait anxiety inventory, functional near-infrared spectroscopy, and heart rate variability. For economic efficiency assessment, quality-adjusted life-years will be the primary outcome using the EuroQol-5 dimension, and the secondary outcome will be using the EuroQol visual analog scale.

Discussion: ETE is a recognized oriental psychotherapy that enhances symptom management, self-regulation, and stress coping. VR is expected to deepen treatment immersion. By combining these strengths, VR-ETE may further improve emotion regulation and alleviate psychosomatic symptoms. If successful, this study will not only advance the treatment of Hwa-Byung but also contribute to the modernization of traditional Korean medicine through the integration of digital therapies.