Effects of smartphone-based music intervention on improving emotional and psychosomatic symptoms of patients with hematological malignancy: A study protocol for a non-inferiority randomized controlled trial

Abstract

Objectives: Smartphone-based music intervention (S-MI) may increase the accessibility and feasibility for benefiting patients. This study aims to assess the effectiveness of S-MI in alleviating emotional and psychosomatic symptoms in patients with hematological malignancies, compared to the smartphone delivered Mindfulness-Based Stress Reduction Training (S-MBSR). Methods: This study will be a non-inferiority randomized controlled trial design. A total of 120 eligible participants with hematological malignancies will be randomly assigned to either the experimental group (S-MI) (n = 60) or the comparison group (S-MBSR) (n = 60). Participants will use the Mind Habit app to participate in daily sessions of S-MI or S-MBSR, lasting 5–10 min each, for 2 weeks. The primary outcome, anxiety, and the secondary outcomes, depression, sleep quality, psychological perceived harmony, emotional regulation self-efficacy, as well as the exploratory outcome performance status, will be assessed four times (i.e., pre-test, mid-test, post-test, and follow-up) using validated instruments: the General Anxiety Disorder-7, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index Inventory, Balanced Index of Psychological Mindedness, Regulatory Emotional Self-Efficacy Scale and Zubrod/ECOG/WHO. In addition, participants will provide daily self-reports on their mood and psychosomatic symptoms both before and after each day's intervention. Physiological parameters will be collected at pre- and post-test. Compliance will be measured at pre-test and follow-up. Intent-to-Treat and Per Protocol Set analysis will be used for data analysis. Results: The primary outcome will focus on evaluating the change of anxiety. Secondary outcomes will examine the changes in depression, sleep quality, psychological perceived harmony, and emotional regulation self-efficacy. The exploratory outcomes will encompass assessments of performance status, self-reported evaluations, physiological parameters, and compliance. Conclusion: This study aims to provide empirical evidence supporting the efficacy of S-MI in mitigating emotional and psychosomatic symptoms in patients with hematological malignancies. Trial Registration: The trial was registered and identified as ChiCTR2200065896.