ENDOUROLOGY AND STONE DISEASE Effect of Different Musical Types on Patient’s Relaxation, Anxiety and Pain Perception during Shock Wave Lithotripsy: A Randomized Controlled Study Ali Çift*, Can Benlioğlu Purpose: The aim of this study was to investigate the effects of listening to different music types during extracor- poreal shock wave lithotripsy (SWL) on the patients’ pain control, anxiety level, and satisfaction. Materials and Methods: This study was a prospective single-blinded, paral¬lel-group randomized clinical trial with balanced ran¬domization [1:1]. A total of 150 patients who underwent first-session SWL were included in the study. The patients were randomly divided in to five groups (30 participants in each group) as follows: headphones were not put on and no music was played in Group 1 (control group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was lis- tened to with headphones in Group 4; thetype of music the patient liked was listened to with headphones in Group 5. Demographic data related to patients and procedure, State-Trait Anxiety Inventory-State Anxiety (STAI-SA), Visual Analog Scale (VAS) scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded immediately after the procedure. Results: There was a statistically significant difference between groups in terms of median VAS scores (7, 6, 4.5, 5, and 4, respectively, P < .001), whereas the VAS scores in Groups 3, 4, and 5 were significantly lower than those in Group 1 and 2 (P < .001). The median STAI-SA scores between the groups were significantly different (45, 45, 42, 45, and 40, respectively, P < .001), while the anxiety levels in Groups 3, 4, and 5 were significantly lower than those in Group 1 (P = .008, P = .018, and P < .001, respectively). Moreover, there were statistically significant dif- ferences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P < .001). Conclusion: Music therapy during SWL reduced the patients' pain and anxiety scores, moreover listening to the patient’s preferred music type provided greater satisfaction. Listening to the patient’s preferred music type could be standardized and routinely used during SWL. Keywords: anxiety; music; nephrolithiasis; pain; shockwave lithotripsy INTRODUCTION Extracorporeal shock wave lithotripsy (SWL) has been used extensively in the treatment of urinary tract stones since the 1980s due to its low morbidity and high efficacy.(1) The most common complaints of the patients undergoing SWL are pain and anxiety. Despite pain reduction with new generation SWL devices, se- vere pain was still reported in 30% of all patients when treated without undergoing analgesia.(2) It is important that patients are kept at the lowest levels of pain and anxiety to ensure their compliance with the SWL procedure. Therefore, many complementary ther- apies have been reported.(3) One of these therapies is music which is a non-pharmacological and non-chemi- cal method and used in addition to traditional care and medical treatment for postoperative pain treatment.(4) Moreover, it is a source of pleasure for many people and has been used throughout history to alleviate sick- ness and pain.(5) In the literature, there are several studies related to lis- tening to music during SWL.(6-12) These studies have shown that music has positive effects on pain and anx- iety during SWL. Individuals' musical preferences are influenced by age, gender, culture, mood, and previous Department of Urology, Faculty of Medicine, Adıyaman University, Adıyaman, Turkey. *Correspondence: Adiyaman University, Faculty of Medicine, Department of Urology, Adiyaman, Turkey Phone:+90 5325701602. Email: dr.alicift@gmail.com. Received May 2019 & Accepted September 2019 musical experience. Different types of music have been shown to affect heart rate, blood pressure, and the fre- quency and depth of breathing.(13) It is important to con- sider the musical preferences of individuals, as these preferences contribute to the therapeutic effect.(14) In this study, patients with upper urinary tract stones undergoing SWL without any medication were as- sessed for their pain and anxiety scores after listening to different music types during the procedure. To our knowledge, this is the first study in the literature inves- tigating the effect of different music types on the pain and anxiety scores of patients during SWL. MATERIALS AND METHODS Study population This prospective randomized study was completed with the permission of the presidency Clinical Research Ethics Committee in Adiyaman University (2016/5-5) between July 2016 and November 2017. Informed con- sent was obtained, and the patients participated volun- tarily in the study. Inclusion criteria were presence of a radiopaque stone 10-20 mm in diameter localized in the renal pelvis or ureteropelvic (UP) junction, not having a ureteral stent, Urology Journal/Vol 17 No. 1/ January-February2020/ pp. 19-23. [DOI: 10.22037/uj.v0i0.5333] age over 18 years, and absence of renal colic before the procedure. Exclusion criteria were previous SWL history, presence of ureteral stent, hearing deficit, un- controlled hypertension and antidepressant drug usage. Patients’ en¬rollment algorithm has been illustrated in Figure 1. Before SWL, the size and localization of the kidney stones were evaluated by plain films (KUB radiogra- phy), ultrasonography and computed tomography. Study design This study was a prospective single-blinded, paral¬lel- group randomized clinical trial with balanced ran¬d- omization [1:1]. Sample size was calculated consider- ing a .30 effect size with One-Way ANOVA expected difference among study groups in the primary outcome of interest. Considering type I error of .05 and type II error of .20, at least 28 cases were needed for eac harm. Therefore 30 cases were decided to be enrolled in eac harm of the study. Sample size estimation was per- formed using G*Power 3.0.10. (Franz Faul, Universität Kiel, Kiel, Germany) statistical package. Patients were randomly assigned to one of the five study groups (30 pa¬tients in each group). Random- ization was carried out using computerized random numbers. The allocated treatment for each patient was recorded in concealed envelopes. All study personel were blinded to treatment assignment. The procedure of simple randomization was followed therefore no re- striction we had such as stratifying or blocking. After achieving eligibility criteria and pa-tient’s agreement on participation, the concealed envelopes were opened by one of the staff who was working at the clinic and unaware of the study. The study was completed by a senior urologist and a staff lithotripsy technician. The patients were randomly divided into five groups as follows: headphones were not put on and no music was played in Group 1 (con- trol group); headphones were put on but no music was played in Group 2; Turkish art music was listened to with headphones in Group 3; Western classical music was listened to with headphones in Group 4; the type of music the patient liked was listened to with headphones in Group 5. The headphones were Sony MDR ZX100. Medication was not administered to any patient in any group be- fore or during the procedure. A total of 150 patients (30 in each group) who underwent first-session SWL were included in the study. The demographic data related to the patient and procedure, pain and anxiety scores, willingness to repeat procedure (0: never 4: happily), and patient satisfaction rates (0: poor 4: excellent) were recorded. Hemodynamic parameters were also recorded before and after the SWL procedure. Outcome assessment Anxiety assessment was performed by using the State- Trait Anxiety Inventory-State Anxiety Scores (STAI- SA) form.(15The anxiety score was calculated as fol- lows: Questions 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 of the 20 questions on the form had opposite statement. The total scores obtained from the reverse statements were subtracted from those of the remaining direct statements. 50 points were added in order to calcu- Effect of different musical types during SWL-Çift et al. Table 1. Demographic and clinical characteristics Group 1 (n=30) Group 2 (n=30) Group 3 (n=30) Group 4 (n=30) Group 5 (n=30) p-value Age (years) 38.4 ± 13.9 39.2 ± 12.1 37.7 ± 10.9 36.3 ± 10.6 36.4 ± 10.2 .883† Gender .081‡ Male 16 (53.3%) 17 (56.7%) 25 (83.3%) 21 (70.0%) 22 (73.3%) Female 14 (46.7%) 13 (43.3%) 5 (16.7%) 9 (30.0%) 8 (26.7%) Body mass index (kg/m2) 26.3 ± 3.3 26.1 ± 2.3 25.6 ± 2.7 26.0±2.3 26.4 ± 1.4 .748† Stone location .963‡ Pelvis 21 (70.0%) 19 (63.3%) 20 (66.7%) 21 (70.0%) 19 (63.3%) Ureteropelvic (up) junction 9 (30.0%) 11 (36.7%) 10 (33.3%) 9 (30.0%) 11 (36.7%) Stone laterality .983‡ Right 11 (36.7%) 12 (40.0%) 11 (36.7%) 12 (40.0%) 10 (33.3%) Left 19 (63.3%) 18 (60.0%) 19 (63.3%) 18 (60.0%) 20 (66.7%) Stone size (mm) 11.5 (10.0-13.0) 12.0 (11.0-14.0)a,b 10.0 (10.0-12.0)a 10.0 (10.0-12.0)b 12.0 (10.0-12.25) .007¶ SWL duration (min) 30.0 (25.0-30.0) 28.5 (25.0-30.0) 30.0 (28.75-30.0) 25.0 (25.0-30.0) 27.5 (25.0-30.0) .185¶ SWL total energy (joule) 80.0 (74.75-92.5) 85.0 (65.0-93.25) 92.0 (82.0-101.25) 90.0 (64.25-103.5) 94.0 (79.75-96.25) .159¶ Total number of shockwaves 2700 (2500-2900) 2725 (2500-2900) 2851.5 (2685.7-3000.0) 2842.5 (2437.2-2958.7) 2800 (2500-2925) .473¶ † One-Way ANOVA, data shown as mean ± SD, ‡ Pearson's Chi-square test, data presented as number of cases and percentages, ¶ Kruskal–Wallis test, descriptive statistics given as median (Q1 – Q3), a: Group 2 vs Group 3 (P < .001), b: Group 2 vs Group 4 (P = .002). Figure 1. Patients’ enrollment algorithm. Endourology and Stones diseases 20 Vol 17 No 01 January-February 2020 21 late the anxiety score (constant value). This score was a minimum value of 20 and a maximum value of 80. Higher scores indicate greater anxiety. Visual analog scale (VAS pain: 0-10) was used to evaluate pain.(16) The zero value was defined as "no pain", while the val- ue 10 was defined as "unbearable pain". The patient was asked to indicate the degree of pain. In all patients, VAS and STAI scores were recorded immediately after the SWL procedure. Treatment success defined as the absence of stone fragments or the presence of clinically insignificant fragments smaller than 4 mm in diameter and being stone-free was assessed by KUB radiography and ul- trasonography on the 15th day of SWL. All recorded parameters were compared between the five groups. SWL technique SWL was performed using a ModularisVario litho- tripter (ModularisVario; Siemens, AG Healthcare, Munich, Germany). ModularisVario is a mobile, fully integrated, next-generation lithotripter with an electro- magnetic shock wave source and fully integrated fluor- oscopic guided device. The energy levels start with E0.1 and progressively increase to a maximum of E8.0 in 38 steps. The average energy level, the maximum energy level, and the total energy delivered were automatically displayed at the end of each session. The patients were treated in the supine position. Fluor- oscopy was used to localize the stone. Lubricating gel was applied to the area where SWL was to be adminis- tered in all patients. For the Kidney: Number of shock waves = 3000-3500, Energy level (max) = 3-4, Starting: 100 shock waves with Level 0.1-1 Afterwards, maxi- mal level: Pelvis: 4.0 with Frequency SW/min = 60. The number of shock waves, their intensity, and their energy were recorded for patients in all groups. Statistical Analysis Normality of continuous variables was determined us- ing Kolmogorov–Smirnov test. Levene test was used for the evaluation of homogeneity of variances. De- scriptive statistics for continuous variables were shown as mean±SD or median (Q1-Q3), as appropriate. Num- ber of cases and percentages were used for categorical data. The mean differences among groups for normally distributed data were compared by One-Way ANOVA, while Kruskal–Wallis test was applied for the compar- isons of variables that were not normally distributed or the variance homogeneity assumption was not met. When the p-values from Kruskal–Wallis test statistics were statistically significant, Conover’s multiple com- parison testwas used to determine which group(s) dif- fered from the others. Categorical data were analyzed using Pearson's Chi- square test. Data analysis was performed by using IBM SPSS Statistics version 17.0 software (IBM Corpora- tion, Armonk, NY, USA). A p-value less than 0.05 was consideredas statistically significant. RESULTS There were no statistically significant differences be- tween the groups in terms of age, mean body mass in- dex, stone localization (P = .883, P = .748, P = .963, respectively). There were no statistically significant dif- ferences between groups in terms of SWL duration, to- tal SWL energy, or total number of shock waves among the groups (P > .05 for all comparison). Demographic and clinical characteristics and SWL variables for the study groups are presented in Table 1. There was a sta- tistically significant difference between the groups in terms of median VAS scores (7, 6, 4.5, 5, and 4, respec- tively), P < .001), while the VAS scores in Groups 3, 4, and 5 were significantly lower than those in Groups 1 and 2 (P < .001). There was not a statistically sig- nificant difference between Groups 1 and 2, Groups 3 and 4, Groups 3 and 5, or Groups 4 and 5 in terms of VAS scores (P = .386, P = .956, P = .112 and P = .100, respectively) (Table 2). There was a statistically sig- nificant difference between groups in terms of median STAI scores (45, 45, 42, 45, and 40, respectively, P < .001), while the anxiety levels in Groups 3, 4 and 5 were statistically lower than that in Group 1 (P = .008, P = .018 and P < .001, respectively). In addition, the anxiety level in Group 5 was statistically lower than Group 2 (P < .001). There was not a statistically significant differ- ence between Groups 1 and 2, Groups 2 and 3, Groups 2 and 4, Groups 3 and 4, Groups 3 and 5, or Groups 4 and 5 in terms of anxiety levels (P = .442, P = .059, P = .107, P = .780, P = .145 and P = .083, respectively) (Ta- ble 2). In addition, there were statistically significant differences between the groups in terms of willingness to repeat the procedure and patient satisfaction rates (P < .001), whereas these parameters were significantly higher in Groups 3, 4, and 5 than in Group 1 (P < .001). In addition, the willingness to repeat the procedure and patient satisfaction rates in Group 5 were significantly higher than those in Groups 3 and 4 ((P = .005 and P < .001), (P = .007 and P = .003), respectively) (Table 2). The stone-free rates were statistically similar between the groups (P = .992) (Table 2). Table 2. Clinical outcomes Group 1 (n=30) Group 2 (n=30) Group 3 (n=30) Group 4 (n=30) Group 5 (n=30) p-value Patient satisfaction rate 1 (1 - 2)a,b,c 2 (1 - 2)d,e,f 2 (1 - 3)a,d,g 2 (1 - 3)b,e,h 3 (2.75 - 3)c,f,g,h <.001† 0=poor to 4=excellent Willingness to repeat procedure 1 (1 - 2)a,b,c 2 (1 - 2)d,e,f 2.5 (1 - 3)a,d,g 2 (2 - 3)b,e,h 3 (3 - 3.25)c,f,g,h <.001† 0=never to 4 happily Visual analog scale (VAS) 7 (6 - 7.25)a,b,c 6 (5 - 7.25)d,e,f 4.5 (4 - 6)a,d 5 (3 - 5.25)b,e 4 (3 - 5)c,f <.001† 0=no pain to 10=unbearable pain STAI-State Anxiety Score 45 (42 - 54)a,b,c 45 (40 - 48.25)f 42 (37.75 - 45)a 45 (32.75 - 45.5)b 40 (31.75 - 45)c,f <.001† min=20 to max=80 Stone-free rate 15 (50.0%) 16 (53.3%) 16 (53.3%) 16 (53.3%) 17 (56.7%) .992‡ † Kruskal–Wallis test, descriptive statistics given as median (Q1 – Q3), ‡ Pearson's Chi-square test, data presented as number of cases and percentages, a: Group 1 vs Group 3 (P < .01), b: Group 1 vs Group 4 (P < .05), c: Group 1 vs Group 5 (P < .001), d: Group 2 vs Group 3 (P < .05), e: Group 2 vs Group 4 (P < .05), f: Group 2 vs Group 5 (P < .001), g: Group 3 vs Group 5 (P < .05), h: Group 4 vs Group 5 (P < .01). Effect of different musical types during SWL-Çift et al. Endourology and Stones diseases 22 DISCUSSION There are many interventions that can be performed in outpatients without anesthesia. One of them is SWL therapy, which has revolutionized the treatment of uri- nary tract calculi because of its cost effectiveness and low morbidity. For these reasons, it remains one of the first choice in the treatment of renal stones up to 20 mm.(17) Patients should be immobile for a while in certain procedures like SWL, Magnetic Resonance Imaging (MRI), and colonoscopy. Disturbing noise and beats from the SWL device can cause the patient to feel pain and anxiety, and to move.(6) Both pain and anxiety can reduce the patient’s tolerance, which can lead to diffi- culty in targeting the stone, preventing maximal energy delivery. Therefore, fragmentation of the stone may fail during the procedure, and patients may refuse addition- al SWL sessions due to pain and anxiety.(7) The success of SWL is closely related to factors such as the patient's compliance with the procedure, the ex- perience of the person using the device, the localization of the stone, urinary system anatomy, and composition of the stone.(18) The patient's pain and anxiety should be kept to a minimal level to provide compliance with the SWL procedure and achieve the highest possible suc- cess rates. Local anesthetic drugs such as EMLA (2.5% lidocaine and 2.5% prilocaine), NSAIDs (diclofenac, ketorolac, and piroxicam), opioids (morphine, fentanyl, and pethi- dine), and anxiolytics (midazolam) can be used before the SWL procedure for these purposes. According to the Urolithiasis Guideline prepared by the European Urolo- gy Association, the recommendation level for pain con- trol is C and the level of evidence is 4.(19) However, side effects such as respiratory depression, hypotension, tachycardia, bradycardia, transient cognitive dysfunc- tion, nausea-vomiting, and allergic reactions may occur due to these drugs.(13) Therefore, complementary treat- ments are becoming increasingly popular in order to reduce pain and anxiety during SWL. These treatments include music, transcutaneous electrical nerve stimula- tion, acupuncture, and auricular acupressure. Music therapy has been shown to reduce pain by acti- vating the cingulofrontal cortex.(20,21) It is also suggest- ed that music has anxiolytic effects and should be used as therapy in stressful interventions. In the literature, there are a few studies about the approach of listening to music during SWL. Koch et al. reported that listening to music during SWL significantly reduced the requirement for alfentanil. (22) Moreover, Cepeda et al. argued that music did not reduce the requirement for alfentanil when using pa- tient-controlled analgesia during SWL. Limitations of this study include the limited number of patients and the use of morphine and ketorolac in addition to pre-proce- dural alfentanil.(23) In another study using music or midazolam during SWL, music was found to be at least as effective as mi- dazolam and had similar STAI-SA and VAS scores.(9) In addition, the common feature of these three studies was the administration of analgesics and anxiolytics to the control group. Patients in our study did not any receive medication. Therefore, our study differs from these studies. In these studies, patients completed SWL sessions by using NSAIDs or drugs such as alfentanil and mida- zolam before the procedure; as a result anxiety scores were found to be lower. Since we did not use any anal- gesics or anxiolytics in our study, our pain and anxiety scores may be slightly higher than those reported in the literature. Akbaş et al. reported in their prospective study that there were lower anxiety and pain scores during SWL sessions in which the patient listened to music. In addi- tion, patients were asked to complete more SWL ther- apy while listening to music, and patients were more satisfied.(6) One of the limitations of this study was that the stone-free rates were not compared between the first and second sessions, while the other limitation was that there was not a third group using only noise-canceling headphones. In a prospective randomized trial by Karalar et al., it was reported that music therapy during SWL reduced pain and anxiety, and that music therapy with active noise-canceling headphones (NCHs) was more effec- tive for pain and anxiety reduction.(7) In the present study, we used active non-noise canceling headphones. Patients receiving music therapy (Groups 3, 4, 5) were found to have lower pain scores than those who did not (Groups 1, 2). When we compared Groups 3, 4, and 5 in terms of music types, there was not a sta- tistically significant difference in terms of VAS scores. In addition, when we compared Groups 1 and 2, there was not a statistically significant difference in terms of VAS scores. The anxiety scores of the patients who re- ceived music therapy in our study (Groups 3, 4, 5) were lower than those who did not receive music therapy (Groups 1, 2). We found that anxiety scores were lower in Group 5 than those in Groups 1 and 2. In addition, when the groups that listened to music were evaluated among themselves in this study, we also found that the ap- proach in which the patient listened to his/her favorite music during SWL had more positive results than the patients listening to other types of music in terms of the willingness to repeat the procedure and satisfaction rates. One limitation in this study was the absence of analge- sic groups. CONCLUSIONS Our results suggest that music therapy during SWL re- duces the level of pain and anxiety. When we compared the groups in terms of music types, it was determined that willingness to repeat the procedure and patient sat- isfaction rates were better when the patients listened to the music types they liked. Music therapy during SWL is a noninvasive, inexpensive, simple, and non-pharma- cological method. Allowing the patients to listen to the music they like using headphones allows SWL to be better tolerated. Thus, patients are protected from un- wanted side effects of drugs. Furthermore during the SWL procedures, listening to the patient’s preferred music type could become standardised. ACKNOWLEDGEMENT This study was approved in University of Adıyaman Institutional Ethics Committee. 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