Effect of music intervention on mental health in patients with diabetes mellitus: protocol for a systematic review and meta-analysis of randomizsed controlled trials.

Introduction About 463 million adults aged 20-79 have diabetes globally. Mental disorders often exist in patients with diabetes as comorbidities, which can lead to aggravation of the diseases, increased difficulties in treatment, as well as elevated mortality rates. Music intervention has been applied in the treatment of comorbidities for 12 years now, but there are still no recommendations due to the lack of evidence. Thus, a meta-analysis is necessary to evaluate the effect of music intervention in treating mental disorders of patients with diabetes. Methods and analysis We will search the following nine online electronic databases from their inception until March 2020: PubMed, Web of Science, Embase, EBSCO, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database (VIP) and Chinese Biomedical and Medical Database. We also plan to search other relevant resources, including grey literature and the reference lists of relevant publications. Only randomised controlled trials of music intervention to treat depression or anxiety in patients with diabetes will be involved. The primary outcomes include the depression score and anxiety score measured on certain scales, and the secondary outcome is safety. Data extraction will be independently implemented by two researchers. The risk of bias will be evaluated through the Cochrane Collaboration's Risk of Bias tool. Eventually, all the data will be analysed via the Review Manager V.5.3 software. Ethics and dissemination This meta-analysis will provide information about applying music intervention to treat depression or anxiety in patients with diabetes. No ethical approval is required because this meta-analysis is based on published data. The results of this systematic review will be published in a peer-reviewed journal. PROSPERO registration number CRD42019146439