Treating Chronic Pain by Modulating Phenomenological and Psychophysiological Indices of Self-Transcendence: Single-Blind Randomized Controlled Clinical Trial Protocol

通过调节自我超越的现象学和心理生理学指标治疗慢性疼痛:单盲随机对照临床试验方案

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Abstract

BACKGROUND: Chronic musculoskeletal pain (CMP) imposes a significant psychological, physical, and emotional burden on millions of adults in the United States. A challenge in treating CMP is its tendency to become enmeshed with a person's sense of self. Mindfulness-based interventions (MBIs) offer a promising approach to help patients disentangle pain from their sense of self. However, rigorous research is needed to determine which styles of mindfulness practice most effectively promote self-transcendence, a candidate mechanism for durable pain relief. OBJECTIVE: This study aims to evaluate whether adding direct pointing instruction to traditional mindful breathing enhances self-transcendence and pain relief. We will assess the effects of 2 mindfulness training protocols, mindful breathing (MB) and MB plus direct pointing (DP) instruction, on subjective and neurophysiological markers of self-transcendence and on pain-related outcomes. METHODS: In this study, we will conduct a 3-arm randomized controlled trial with 173 adults with CMP, assigned to one of the following groups: (1) 4, 30-minute sessions of traditional mindful breathing instruction, (2) 4, 30-minute sessions of MB+DP instruction, or (3) a waitlist control group. Self-transcendence will be assessed during the first and final intervention sessions using validated self-report measures and psychophysiological indices, including electroencephalography (EEG; theta activity) and functional near-infrared spectroscopy (fNIRS; default mode network [DMN] activity). Primary outcomes include changes in self-transcendence, theta activity, and DMN activity. Additional outcomes include acute pain intensity and pain-related functional interference, measured at baseline through 3-month follow-up. RESULTS: Data collection began in October 2024 and will conclude by May 2027. As this is a protocol paper, no results are yet available. We will report recruitment rates, baseline characteristics, and initial outcome trends in the full trial results paper. CONCLUSIONS: This will be the first randomized controlled trial to examine whether direct pointing instruction enhances analgesia by eliciting self-transcendence. Findings may advance understanding of the mechanisms underlying mindfulness-based pain relief and inform the development of more targeted MBIs for chronic pain. Results will be disseminated through peer-reviewed publications, conference presentations, and stakeholder engagement, with potential implications for clinical practices.

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