Music assisted nitrous oxide oxygen inhalation sedation in pediatric dentistry: a prospective three-arm randomized clinical trial
Nitrous oxide–oxygen inhalation sedation (NOIS) is the recommended first line pharmacological approach for managing dental anxiety in children. Music, owing to its psychoacoustic qualities and autonomic nervous system-influencing potential, emerges as a potential non-pharmacological agent in the management of dental anxiety. The aim of this study was to assess the efficacy of Indian instrumental music as an adjunct to nitrous oxide-oxygen Inhalation sedation. This prospective, three arm parallel- group randomized clinical trial was conducted at the Department of Pediatric and Preventive Dentistry, Yenepoya Dental College, Mangalore (CTRI/2024/04/065857). A total of 39 anxious child participants between the ages of 9 and 12 years (Mean age = 10.56 ± 1.14 years) who required restorative procedures under NOIS, as assessed by MCDASf were included in the study. They were equally distributed among the groups, i.e., Group A (Control Group), Group B (NOIS music through ambient speakers), and Group C (NOIS with music through earphones), each consisting of 13 participants. The intervention used was ‘Minuet in D major' from the album ‘Classicool' performed by sitar maestro Purbayan Chatterjee. Physiological responses such as systolic BP, diastolic BP, and pulse rate PR) were recorded. The earphone group (Group C) showed statistically significant change over time for all physiological parameters. p = 0.003, p = 0.011, p = 0.030, respectively, for systolic bp, diastolic bp, and PR. Intergroup comparisons revealed no statistically significant differences at baseline or post-intervention. A statistically significant between-group difference was noted during the intervention phase exclusively for PR (p = 0.014). The music intervention demonstrated high overall acceptability; 88.5% of participants reported liking the music and 84.6% indicated a desire for its continuation in future appointments (p = 1.000). The use of Indian instrumental music as an adjunct to NOIS in Earphone-delivered music demonstrated statistically significant within-group reductions in all physiological parameters, with a significant intergroup difference in pulse rate during intervention (p = 0.014). Most intergroup differences were non-significant, and these findings should be interpreted as clinically promising trends warranting larger randomized trials rather than definitive evidence of efficacy. Clinical Trial Registration CTRI/2024/04/065857, https://ctri.nic.in/Clinicaltrials/searchbyctri.php