Effect of Alpha soundwave auditory stimulation on anxiety levels in patients undergoing endodontic treatment: A Randomised Controlled trial

The current study will be a single-center, triple-blinded, placebo-controlled, two-arm, parallel design (allocation ratio 1:1) randomized controlled trial. Those patients who have a score of ≥ 11 will be randomly divided into two groups, the Control group (No auditory stimulation) and the Experimental group (Auditory alpha stimulation).Pre-operative diastolic-systolic blood pressure and heart rate will be recorded for all patients by a third person, unrelated to the study by standardized apparatus(Omron HEM 7120, Omron Healthcare Manufacturing, Thu-dau-mot, Vietnam)  Patient will be blinded to the study. Based on the allocated group the subjects will be asked to wear noise cancellation headphones(Sony WH-CH510/BZ,Sony, Tokyo, Japan) by a nurse who isn’t part of the study where auditory stimulation for alpha waves will be done via playlist available on a software application available on mobile phones. (Brainwaves, iMobLife Information Technology CoLtd) for 15 minutes in the experimental group. In the control group, the patients will be asked to wear the headphones and no auditory stimulation will be given. Hemodynamic findings(blood pressure and heart rate) will be again recorded after auditory stimulation at this point. A single trained operator who is also blinded to the intervention given will be performing single sitting root canal treatment to standardize the bias associated with the skill of the operator, After the treatment is completed, hemodynamic findings will be recorded and assessed by a blinded outcome assessor. The parameters used to analyze anxiety are blood pressure, heart rate, and a modified dental anxiety scale. Kolmogorov-Smirnov test will be applied to check whether the data fits the normal distribution, Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation, and continuous variables not conforming to normal distribution will be expressed as median and inter-quartile range. Counting data will be expressed as numbers and percentages. The independent-sample t-test/Mann-Whitney test will be used for inter-group analysis of quantitative data while paired sample t-test/Wilcoxon signed rank test will be used for intragroup analysis. The chi-square ( χ2) test will used to compare the proportion data between the groups and the intubation accuracy of the two groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant..