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.