Vol 13 No 02 March-April 2016 2590Vol 13 No 02 March-April 2016 2612 Purpose: The purpose of this study was to assess the impact of music on anxiety and perceived pain during trans- rectal ultrasound-guided prostate biopsy. Materials and Methods: Forty consecutive men with an elevated serum prostate specific antigen (PSA) level and/ or an abnormal digital rectal examination referred for transrectal ultrasound-guided prostate biopsy were recruited and allocated to a music (n = 20) or a non-music (n = 20) group. Anxiety was assessed prior to and after biopsy and pain was assessed after biopsy in each patient using visual analog scales (VAS) in the same setting, and group anxiety scores were compared. Results: Patients in the music group experienced less anxiety (P = .046) during the procedure, but group pain scores were not significantly different. Conclusion: Music was found to decrease anxiety effectively during transrectal ultrasound-guided prostate biopsy. Keywords: prostatic neoplasms; diagnosis; ultrasonography; interventional/methods; biopsy; pain management; analgesia; anxiety; prevention & control; music therapy; instrumentation. INTRODUCTION The prostate is the most common site of cancer in older males in the US, and transrectal ultra- sound-guided prostate biopsy is the standard procedure used to determine the presence of prostate cancer.(1,2) Local anesthesia is usually adopted to reduce anxiety and pain during prostate biopsy, but some studies have reported that a considerable proportion of patients ex- perience significant anxiety and pain.(3,4) Furthermore, it has been suggested that anxiety and pain related to prostate biopsy are influenced not only by physical as- pects of the procedure but also by psychological factors. (5) However, no study has previously investigated the use of music to reduce anxiety and pain during prostate biopsy. Accordingly, the aim of the present study was to investigate the impact of music on anxiety and pain during transrectal ultrasound-guided prostate biopsy. MATERIALS AND METHODS Institutional review board approval was not required for this study and written informed consent was ob- tained from all patients prior to study commencement. The study was performed using a prospective, rand- omized design on 40 consecutive men suspected of having prostate cancer and scheduled for transrectal ultrasound-guided biopsy from June 2004 to December 2004. The inclusion criteria for the study were an el- evated serum prostate specific antigen (PSA) level (≥ 4.0 ng/mL) and/or abnormal digital rectal examination findings. No patient had a history of previous prostate biopsy. Patients with a painful condition of the rectum and/or anus (e.g., hemorrhoids, anal fissure, or clini- cally evident prostatitis) or a known allergy to prilo- caine were excluded from the study; 10 patients were excluded for these reasons. Patients allocated to the mu- sic and non-music groups randomly using a computer generated randomization list. Group designations were placed in sealed envelope and allocated consecutively. All study participants and those that assessed outcomes were unaware of group assignments. Patients in the experimental group chose music before the procedure from a compilation of ballads. Volume and pitch were controlled at a comfortable level. Mu- sic was played continuously from before patient arrival until after patient departure. A controlled environment was created to minimize the effects of additional vari- ables. The office door was closed, a “research in pro- gress-do not disturb” sign was posted and lights were turned on. Before biopsy, anxiety was assessed in each subject using a visual analog scale (VAS). Bilateral UROLOGICAL ONCOLOGY Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial Seong Whi Cho, Hyuck Jae Choi* Department of Radiology, Kangwon National University Hospital, Chuncheon, Korea. *Correspondence: Department of Radiology, Kangwon National University Hospital, 156 Baengnyeong-ro, Chuncheon 200- 722, Korea. Tel: +82 33 2582479. Fax: +82 33 2582120. E-mail: choihjmd@gmail.com. Received September 2015 & Accepted February 2016 periprostatic nerve blockages (PNB) were performed bilaterally using 5 mg of 1% prilocaine into the pros- tatic vascular pedicle region. Each subject also assessed for pain during anesthesia, biopsy, and immediate after biopsy using a 10 point VAS scale, were 0 indicated “no pain” and 10 indicated “worst pain imaginable”. Fluoroquinolone was administered 30-60 min before biopsy and continued for 2-3 days after biopsy. The primary outcome measures were VAS anxiety and pain scores during prostate biopsy. There was no sec- ondary outcome measure because music therapy has no side effects is easily performed. The Mann-Whiney U test was used to compare group scores. P values of < .05 were considered statistically significant, and post-hoc powers were calculated. RESULTS Of 50 men that underwent biopsy at our institute dur- ing a 7-month period, 40 were randomized equally to the music (n = 20) or non-music (n = 20) groups. The two groups were well-matched, and no significant in- tergroup differences were found for patient character- istics, which included prostate volume, PSA level, and age (Table). A statistical difference was found between VAS anxiety scores before prostate biopsy (P = .046) but no significant difference was found between pain scores during anesthesia, during biopsy, or immediately after biopsy (Table). Post-hoc power analysis showed statistical power was greatest for pre-biopsy anxiety. DISCUSSION Transrectal ultrasound-guided prostate biopsy is an important component of the urologic armamentarium and is frequently performed in offices and outpatient urology centers worldwide.(1,2) Men undergoing trans- rectal ultrasound-guided prostate biopsy experience considerable stress, due to fear of a diagnosis of cancer, anal penetration, anticipated pain, and fear associated with the fact that the subject organ is part of the sexual system.(2,6) Music therapy has been demonstrated to be effective in patients before surgery and in medically ill patients(8-13) and to reduce sympathetic nervous system activity, to induce a relaxation response, and to produce a sense of well-being.(11,12) Recently the effectiveness of music therapy has been evaluated for biopsies and other painful procedures and shown to usefully reduce anxiety and pain.(14-17) Furthermore, it has been report- ed music may increase pain thresholds by promoting relaxation and reducing anxiety(18,19) and to distract patients from worries and anxieties, and thus, reduce pain and distress.(20,21) In the present study, a significant reduction in anxiety was found pre-biopsy step with a statistical power of 72.5%. On the other hand, pain scores were not significantly different in the two study groups, no significant pain reduction was observed in the music group during or immediately after biopsy. Some limitations of this study warrant consideration. First, the number of patients enrolled was small, which we suspect was responsible for the lack of significant differences between pain scores. Second, pain associat- ed with ultrasound probe manipulation and anxiety on arrival at the office were not assessed. Third, we used a VAS scale to evaluate anxiety rather than the Hamilton Anxiety Scale or the Beck Anxiety Inventory, and thus, we suggest that these tools be utilized any future study. CONCLUSIONS In conclusion, this preliminary study suggests music can reduce anxiety before transrectal ultrasound-guided prostate biopsy, and that, although not found to be sta- tistically significant, music has the potential to reduce pain during and after the procedure. ACKNOWLEDGMENTS This research was supported by grants from National Research Foundation of Korea grant funded by the Ko- rean government (No. 220090083512). CONFLICT OF INTEREST None declared. Table. Patient characteristics and visual analog scale scores for music and non-music groups. Groups Prostate Serum PSA Age (year) Visual Analog Scale Score Volume (cm3) (ng/mL) Anxiety* Anesthesia Biopsy Anxiety** Music (n = 20) 65.4 ± 49.4 16.3 ± 12.2 63.4 ± 7.2 5.6 ± 1.8 5.0 ± 2.2 5.6 ± 2.5 4.1 ± 2.1 Non-music (n = 20) 68.1 ± 37.1 13.41 ± 11.8 59.8 ± 10.9 4.2 ± 1.7 4.8 ± 2.3 5.6 ± 2.4 5.0 ± 2.6 P value .246 .766 .502 .046 .663 .865 .303 Abbreviations: PSA, prostate specific antigen. * Anxiety before biopsy. ** Anxiety after biopsy. Values are presented as mean ± standard deviation Effect of Music on Transrectal Ultrasound Guided Prostate Biopsy-Cho et al. Urological Oncology 2613 Vol 13 No 02 March-April 2016 2614 REFERENCES 1. Cooner WH, Mosley BR, Rutherford CL, et al. 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