A randomized controlled trial on the efficacy of binaural beats in reducing anxiety and pain levels in patients undergoing conventional urodynamic study. Preliminary data and perspectives.

Vedovo F1, Leonardo Martini J1, Morreale C1, Balzarro M2, Rubilotta E2, Marini M2, Gubbiotti M3, Giommoni V3, Capogrosso P4, Di Blas L5, Trombetta C6

Research Type

Clinical

Abstract Category

Urodynamics

Abstract 151
Urodynamics
Scientific Podium Short Oral Session 20
Thursday 28th September 2023
13:45 - 13:52
Theatre 102
Clinical Trial Urodynamics Equipment Pain, other Prospective Study Questionnaire
1. Urology Clinic, Department of Medical, Surgical and Health Science, University of Trieste, 2. Urology Clinic, A.O.U.I of Verona, 3. Department of Urology, San Donato Hospital, Usl Toscana Sud-Est, Arezzo., 4. Department of Urology and Andrology, Ospedale di Circolo and Macchi Foundation, Varese., 5. Department of Life Sciences, University of Trieste, 6. Urology Clinic, Department of Medical, Surgical and Health Science, University of Trieste, Trieste.
Presenter
Links

Abstract

Hypothesis / aims of study
Binaural beats  (BB) are a perceptual phenomenon that occurs when presenting separately to each ear two tones that slightly differ in their frequency. The resulting perception is of a single tone with a frequency that is midway between the two carrier tones and that waxes and wanes in amplitudes at a rate equal to the difference between them. Many studies have shown that BB affect memory, anxiety levels, attention and perceived pain in a passive automatic manner. Hence the application of BB to reduce pain and anxiety levels in many medical procedures. We aim to investigate the effects of BB on anxiety and pain scores in patients undergoing conventional urodynamic study (UDS).
Study design, materials and methods
Multi-center, prospective, single-blinded, randomized controlled trial. Exclusion criteria: wear a hearing aid, history of epilepsy, psychiatric disorder or chronic pelvic pain, the use of antidepressants, anxiolytic and/or analgesic drugs, history of previous UDS. Eligible patients scheduled to undergo UDS were randomly allocated in three groups: Classic Music (CM) who listened by headphones to Samuel Barber's Adagio for Strings, Binaural Music (BM) who listened by headphones Adagio for Strings embedded with a BB frequency of 6 Hz and No Music group (NM) who did not listen to music during UDS. State-Trait Anxiety Inventory form Y (STAI-Y) and Visual Analog Scale (VAS) were used for measuring anxiety and pain scores, respectively. Blood pressure and heart rates were measured for pain and anxiety-related physiological outcomes before and after the UDS. The main outcome was to assess differences between groups in post-procedure improvement of the state STAI-Y (Y1) score from baseline and in VAS scores. Kruskal-Wallis rank test and Pearson’s chi-square were used to compare differences in continuous and categorical factors between groups. Differences in pre- vs. post-UDS psychometric scores were analysed with paired t-test. Statistical analysis were performed using STATA 14.0 (StataCorp, College Station, TX, USA), with a two-sided significance level set at p<0.05.
Results
A total of 90 patients were enrolled until January 2023. Demographics, comorbidities, baseline STAI-Y levels and procedure time were comparable between groups (Table 1). Post UDS STAI-Y1 levels decreased significantly in NM and CM groups (p=0.0002, p=0.0001 respectively). No statistically significant differences were detected between groups for VAS score.
Interpretation of results
According to these preliminary data, binaural beat does not seem to reduce anxiety and pain levels in patients undergoing UDS. In contrast with previous studies published on this topic, classic music seems to reduce anxiety in patients performing (1-3).
Concluding message
Classic music could be a non-harmful, non-pharmacological and inexpensive tool to alleviate anxiety in patients undergoing UDS. Further data are needed to understand the effects of binaural beats on anxiety and pain due to UDS.
Figure 1
References
  1. Kyriakides R, Jones P, Geraghty R, Skolarikos A, Liatsikos E, Traxer O, et al. Effect of Music on Outpatient Urological Procedures: A Systematic Review and Meta-Analysis from the European Association of Urology Section of Uro-Technology. J Urol. 2018.
  2. Diri MA, Çetinkaya F, Gül M. The Effects of Listening to Music on Anxiety, Pain, and Satisfaction during Urodynamic Study: A Randomized Controlled Trial. Urol Int. 2019.
  3. Shim JS, Chae JY, Kang SG, Park JY, Bae JH, Kang SH, et al. Can Listening to Music Decrease Pain, Anxiety, and Stress During a Urodynamic Study? A Randomized Prospective Trial Focusing on Gender Differences. Urology. 2017.
Disclosures
Funding NONE Clinical Trial Yes Registration Number N.O. 119/January2022 RCT Yes Subjects Human Ethics Committee University Ethics Committee of the University of Trieste Helsinki Yes Informed Consent Yes
Citation

Continence 7S1 (2023) 100869
DOI: 10.1016/j.cont.2023.100869

05/11/2024 22:36:46