Effects of music therapy with standard care, in contrast to standards care only, in improving diabetes in adults with diabetes mellitus attending clinic at National Hospital of Sri Lanka

INTERVENTION: Study setting: NHSL Colombo, General Medicine Clinic. Method of randomization: Stratified block randomization will be used to divide the participants in to the music therapy intervention group and the control group and stratification will be conducted considering age groups, as 40% from the age category of patients who are less than 60 years of age and 60% from the age category of patients who are more than 60 years of age. Intervention: The patients selected for the music therapy intervention will be asked to listen to each of the customized music therapy tracks for three minutes each, and mark in a visual analogue scale how relaxed they felt while listening to each type of music. The tracks identified as having a high relaxation effect will be prescribed as his/her treatment. The intervention group patients will be provided with a MP3 player each with headphones free of charge. They will be requested to listen to the prescribed music, uninterrupted for 30 minutes, every day. They will be provided a diary to mark the duration they spent listening as well as keep a note of the days they failed to do so. Research assistants would telephone the patients once a week and attend the clinic on the days the patient would come and record the clinical observations and biochemical test results. The control group will have ‘usual care’ with no request to spend any amount of time seated in a place. Duration of intervention: The intervention will continue for one year. CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Number of participants with a reduction of HbA1c by at least 0.5 from baseline levels. [0 months, 3 months, 6 months, 9 months, 12 months following Music Therapy (MT) ]; SECONDARY OUTCOME: Change in mean scores of PHQ9 questionnaire which measures perceived stress and depression. . [0 months, 3 months, 6 months, 9 months, 12 months following MT ; ; ; ]; Change in mean blood pressure. [ 0 months, 3 months, 6 months, 9 months, 12 months following MT]; Significant changes in relative expressions of miRNAs related to type 2 diabetes mellitus [0 months, 6 months, 12 months following MT ]; Identify miRNA markers related to type 2 diabetes mellitus. [0 months,6 months,12 months following MT ]; []; [ ; ]; [ ]; [ ; ]; [ ; ]; [ ]; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; [ ]; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; []; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; . []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ]; [ ; ; ]; []; [ ; ; ]; [ ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; []; [ ; ; ; ]; [ ; ; ; ]; [ ]; [ ; ; ]; [ ; ; ]; []; []; []; []; []; []; []; []; []; []; []; []; []; []; []; []; []; []; []; INCLUSION CRITERIA: • Adults (Age range from 18 years to 75 years) • both genders • with type 2 diabetes attending a general medicine clinic, • HbA1c value 7.5% or higher