Effects of music therapy on anxiety in patients with cancer: study protocol of a randomised controlled trial.

INTRODUCTION: Although music therapy (MT) has been found to reduce anxiety in patients with cancer and delay tumour progression to some extent, its mechanism of action has not been determined. MT may reduce anxiety by reducing the concentrations of proinflammatory cytokines. The present study was designed to evaluate the effects of MT on anxiety and cytokine levels in patients with cancer. METHODS AND ANALYSIS: This randomised, open, single-centre parallel-controlled trial will randomise 60 patients with malignant tumours who meet the inclusion criteria in a 1:1 ratio to either an MT group or a non-MT (NMT) group. Patients in the MT group will receive emotional nursing care and individualised receptive MT for 1 week, whereas patients in the NMT group will receive emotional nursing care alone. Primary outcomes will include scores on the State-Trait Anxiety Inventory, Distress Thermometer and Hamilton Anxiety Scale. Secondary outcomes will include scores on the Quality of Life Questionnaire C30, serum concentrations of the cytokines interleukin (IL)-1ß, tumour necrosis factor-α, IL-2R, IL-4, IL-6, IL-8 and IL-10, serum concentrations of the neurotransmitters 5-hydroxytryptamine, dopamine, norepinephrine, adrenocorticotropic hormone and γ-aminobutyric acid, and determination of gut microbiota populations. ETHICS AND DISSEMINATION: On 5 August 2020, the study protocol was approved by the Research Ethics Committee of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of the Shanghai University of Traditional Chinese Medicine. The findings of this study will be published in peer-reviewed publications and presented at appropriate conferences. TRIAL REGISTRATION NUMBER: CTR2000035244.

Care patterns and Traditional Chinese Medicine constitution as factors of depression and anxiety in patients with systemic sclerosis: A cross-sectional study during the COVID-19 pandemic.

Objective: Care patterns and Traditional Chinese Medicine (TCM) constitution affects the emotion and health of patients with systemic sclerosis (SSc) while the prevalence of COVID-19 may aggravate such patients' emotion and health. We investigated the depression and anxiety levels of patients with SSc during the pandemic to identify the correlation between care patterns, TCM constitution, and patients' emotion. Materials and methods: This was a cross-sectional study. Patients with SSc and healthy individuals were surveyed using the patient health questionnaire-9, generalized anxiety disorder-7, and constitution in Chinese medicine questionnaire and a modified care pattern questionnaire. Factors correlated with depression and anxiety were screened using univariate and multivariate logistic regression analyses. Results: A total of 273 patients with SSc and 111 healthy individuals were included in the analysis. The proportion of patients with SSc who were depressed was 74.36%, who had anxiety was 51.65%, and who experienced disease progression during the pandemic was 36.99%. The proportion of income reduction in the online group (56.19%) was higher than that in the hospital group (33.33%) (P = 0.001). Qi-deficiency [adjusted odds ratio (OR) = 2.250] and Qi-stagnation (adjusted OR = 3.824) constitutions were significantly associated with depression. Remote work during the outbreak (adjusted OR = 1.920), decrease in income (adjusted OR = 3.556), and disease progression (P = 0.030) were associated with the occurrence of depression. Conclusion: Chinese patients with SSc have a high prevalence of depression and anxiety. The COVID-19 pandemic has changed the care patterns of Chinese patients with SSc, and work, income, disease progression, and change of medications were correlates of depression or anxiety in patients with SSc. Qi-stagnation and Qi-deficiency constitutions were associated with depression, and Qi-stagnation constitution was associated with anxiety in patients with SSc. Trial registration: http://www.chictr.org.cn/showproj.aspx?proj=62301, identifier ChiCTR2000038796.