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Background: Several methods have been reported to minimize patient discomfort during colonoscopy, none are currently recommended by clinical practice guidelines. We performed a single-blind randomized controlled trial to assess the efficacy of music for colonoscopy., Methods: 109 patients were randomized to music-delivering or mute headphones before and during colonoscopy. Physicians were blinded to the trial. Sedation was given on demand. Primary outcome was pain measured on linear analogue scale from 0 to 10. Secondary endpoints were the difficulty of the procedure, need of sedation, overall patient satisfaction and willingness to repeat the procedure., Results: Mean pain score was 5.9±2.2 in the control group vs. 3.8±1.9 in the music group (p<0.00001); correspondingly overall satisfaction and willingness to repeat the procedure were significantly improved by music and the difficulty perceived by physicians was significantly reduced. Total administered midazolam was 36mg in the control group vs. 13 in the music group (p<0.007), pethidine was 860mg vs. 465mg (p=0.07) and patients requiring sedation were 22 vs. 9, respectively (p=0.003). A multivariable analysis to adjust treatment effect for potential confounding factors confirmed the significant beneficial effect of music., Conclusions: Music significantly reduces discomfort and should be routinely offered to patients undergoing colonoscopy., (Copyright © 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)