METHODS: A participant blinded, multi-centre, randomised controlled trial was conducted in which the participants in the intervention group (IG) practiced deep breathing exercise guided by sound cues and those in the control group (CG) listened to the music. The primary end point was reduction in blood pressure at eight weeks.
RESULTS: 87 patients, 46 males and 41 females with mean age of 61.1 years were recruited and 93.1% of them successfully completed the study. There was significant reduction in systolic and diastolic Blood Pressure from baseline by 8 weeks in both groups. The reduction in Mean systolic blood pressure (SBP) in the control arm was 10.5mmHg compared to 8.3mmHg (p<0.001) in intervention group. Diastolic blood pressure (DBP) reduction in control and intervention groups were 5.2 mmHg (p<0.001) and 5.6 mmHg (p<0.001) respectively. The absolute difference in SBP reduction from baseline in IG & CG was -2.2 (95%CI: -7.8 to 3.5) and DBP was -0.4 (95%CI: -2.9 to 3.6). However, blood pressure reduction between the two groups was not significant.
CONCLUSIONS: Both listening to music and deep breathing exercise were associated with a clinically significant reduction in SBP and DBP. However, deep breathing exercise did not augment the benefit of music in reducing BP.
METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.