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基于虚拟现实与传统情感对情感疗法治疗火病的疗效和安全性:一项单中心、随机、评估者盲法、平行组临床试验方案

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.

作者信息

Kook Hye Jeong, Kang Dong Hoon, Park Yang Chun, Kim Nam Kwen, Kang Hyung Won, Jung In Chul

机构信息

Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University, Daejeon 34520, Republic of Korea.

Department of Internal Medicine, College of Korean Medicine, Daejeon University, Daejeon 34520, Republic of Korea.

出版信息

Healthcare (Basel). 2024 Nov 30;12(23):2407. doi: 10.3390/healthcare12232407.

DOI:10.3390/healthcare12232407
PMID:39685029
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11641232/
Abstract

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.

摘要

背景

火病是一种在韩国流行的文化相关综合征,其特征为与压抑愤怒相关的强烈情绪困扰和身体症状。患者经常报告有胸闷、发热感和咽部异物感(喉咙有肿块的感觉)。这些身体症状常伴随心理困扰,并可能加剧与该病症相关的挫败感和无助感。这些症状的独特表现凸显了针对火病的情绪和身体方面进行治疗干预的必要性。传统治疗方法,如意情疗法(ETE),已显示出对治疗该病的有效性。本研究旨在评估基于虚拟现实的意情疗法(VR-ETE)与传统ETE相比的疗效,利用沉浸式数字平台增强治疗参与度。

方法

这项单中心、随机、评估者盲法、平行组临床试验将招募96名参与者,平均分为两个实验组和一个对照组。在八周内,每位参与者将接受12次干预疗程。实验组1将接受传统ETE,实验组2将接受VR-ETE,对照组将接受火病管理培训材料。主要结局将是症状的变化,通过火病主要症状李克特量表从基线到8周进行测量。次要结局将包括心理测量量表和生理指标,如核心七情量表简表、身体健康问卷、应激反应指数、贝克抑郁量表、状态-特质愤怒表达量表、状态-特质焦虑量表、功能性近红外光谱和心率变异性。为了进行经济效率评估,使用欧洲五维度健康量表(EuroQol-5 dimension)将质量调整生命年作为主要结局,使用欧洲五维度健康量表视觉模拟量表作为次要结局。

讨论

意情疗法是一种公认的东方心理治疗方法,可增强症状管理、自我调节和应激应对能力。虚拟现实有望加深治疗的沉浸感。通过结合这些优势,VR-ETE可能进一步改善情绪调节并减轻身心症状。如果成功,本研究不仅将推进火病的治疗,还将通过整合数字疗法为韩国传统医学的现代化做出贡献。

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