Perioperative music may reduce pain and fatigue
Transcription
Perioperative music may reduce pain and fatigue
Acta Anaesthesiol Scand 2013; ••: ••–•• Printed in Singapore. All rights reserved © 2013 The Acta Anaesthesiologica Scandinavica Foundation Published by Blackwell Publishing Ltd. ACTA ANAESTHESIOLOGICA SCANDINAVICA doi: 10.1111/aas.12100 Perioperative music may reduce pain and fatigue in patients undergoing laparoscopic cholecystectomy M. Graversen and T. Sommer Department of Surgery, Randers Region Hospital, Randers, Denmark Background: Acute post-operative pain is a predictor in the development of chronic pain after laparoscopic cholecystectomy. Music has been shown to reduce surgical stress. In a randomized, clinical trial, we wanted to test the hypothesis that perioperative and post-operative soft music reduces pain, nausea, fatigue and surgical stress in patients undergoing laparoscopic cholecystectomy as day surgery. Method: The study was performed in otherwise healthy Danish patients eligible for day surgery. Ninety-three patients were included and randomized to either soft music or no music perioperatively and post-operatively. Using visual analog score pain, nausea and fatigue at baseline, 1 h, 3 h, 1 day and 7 days after surgery were recorded. C-reactive protein and cortisol were sampled before and after surgery. Results: Music did not lower pain 3 h after surgery, which was the main outcome. The music group had less pain day 7 (P = 0.014). Nausea was low in both groups and was not affected E very year, around 7500 laparoscopic cholecystectomies are performed in Denmark. The course of surgery has changed dramatically since the introduction of laparoscopic approach to gallbladder surgery in 1985.1 Prior to the laparoscopic approach, postoperative pain was a substantial problem, and patients were often admitted for several days. Today, the laparoscopic approach is a standard procedure and often performed as day surgery. Usually, laparoscopic cholecystectomy (LC) only lasts about 30–45 min. Patients are discharged 3–6 h after surgery without any restraints on their level of physical activity. Post-operative pain is a main side effect to LC and influences the patient’s satisfaction and convalescence after surgery. In patients with a history of gallstone attacks, a modified and hypersensitive pain perception from the area of the gall bladder can be measured in the brain,2 and because strong and acute post-operative pain is a predictor for chronic pain development,3,4 early multimodal pain management is important in the post-operative by music. The music group experienced less fatigue at day 1 (P = 0.042) and day 7 (P = 0.015). Cortisol levels decreased during surgery in the music group (428.5–348.0 nmol/l), while it increased in the non-music group (443.5–512.0 nmol/l); still, the difference between the two groups were only significant using general linear models as post-hoc analysis. Soft music did not affect C-reactive protein levels. Conclusion: Soft music did not reduce pain 3 h after laparoscopic cholecystectomy. Soft music may reduce later postoperative pain and fatigue by decreasing the surgical stress response. Accepted for publication 8 February 2013 © 2013 The Acta Anaesthesiologica Scandinavica Foundation Published by Blackwell Publishing Ltd. setting.5 In several studies, music has been used to decrease post-operative pain and discomfort. Nilsson et al. demonstrated that perioperative and post-operative music reduced post-operative pain in patients undergoing variceal surgery or open inguinal herniotomy.6,7 Furthermore, Leardi et al. demonstrated a decrease in cortisol levels when patients were exposed to perioperative music.8 However, Migneault et al. did not find any beneficial effects from intraoperative music on changes in cortisol levels.9 During heart surgery, music reduces anxiety and pain,10,11 and in patients undergoing colonoscopy, one meta-analysis concluded that music reduces stress, pain and anxiety,12 while another meta-analysis concluded that soft music improved the overall experience of patients.13 A Cochrane review in 200614 concluded that music may modify surgical pain intensity; however, differences between studies in surgical procedures, techniques, music media, scoring systems and heterogeneous study groups made comparisons 1 bs_bs_banner M. Graversen and T. Sommer difficult. No study has been performed in patients undergoing laparoscopic surgery. In a randomized, clinical trial with patients undergoing LC, the aim of this study was to evaluate the impact of soft music on post-operative pain, nausea, fatigue and surgical stress as measured by changes in cortisol- and C-reactive protein (CRP) levels. Our hypothesis was that listening to soft music reduces the levels of post-operative pain, nausea and fatigue. Furthermore, we anticipated that listening to soft music may reduce surgical stress. Methods The study conforms to the Helsinki declaration, was approved by The Danish National Committee on Biomedical Research Ethics (Ref: 20080031, approved 01.08.2008) and registered at http:// www.clinicaltrials.gov protocol record 20080031. From September 1, 2008 until March 1, 2011, all patients scheduled for LC were invited to participate in the study. Inclusion criteria were ⱖ 18 years of age and uncomplicated cholecystolithiasis (no prior cholecystitis, cholangitis or choledocholithiasis). Exclusion criteria were: pregnancy; conversion to open surgery; systemic steroid; or daily morphine treatment, a history of gastrointestinal surgery within the past 2 weeks or if the patient was incapable of understanding the given information. Furthermore, patients were excluded if they were admitted to the hospital after surgery. Randomization The study was designed as a randomized, clinical trial. Each day of surgery, an envelope was picked containing information whether or not music should be used for all patients that day (like ‘flip a coin’). The unit nurse was responsible for the randomization, and the staff nurses registered the patient data. The scheme of randomization was kept secret until data from all patients were collected. Surgery Pneumoperitoneum of 12 mmHg was created by the use of a Veress needle, and two 12-mm and two 5-mm ports were used. A standard LC was performed, and the gall bladder was removed from the abdomen through the epigastric or umbilical port site. Carefully, the abdomen of all patients was completely desufflated. At the port sites, 40 ml bupivacaine 0.25% was injected subcutaneously. Lesions of the gallbladder with bile contamination or other 2 surgical complications were registered. In case of bile contamination, thorough peritoneal lavage was performed. All patients received standard postoperative analgesic treatment with ibuprofen 400 mg ¥ 4 and paracetamol 1 g ¥ 4 for 3 days. Amount of anesthetics and fluids administered during surgery were recorded as well. Intervention and outcome assessment A music pillow with an integrated mp3 music player with soft music from Musicure® (Gefion Records, Copenhagen, Denmark – a company that designs music to reduce stress) was placed behind the patient’s head before surgery and used until discharge from the day surgery department. In cases where patients were randomized to non-music, the pillow was placed, but the player was not started. Primary end point: The primary end point was post-operative pain 3 h post-operatively measured by using the visual analog scale 0–10 (VAS). In addition, pain was estimated 1 h post-operatively using VAS and by phone after 1 and 7 days using the numeric rating scale (NRS) where 0 = no symptoms and 10 was worst degree of symptoms. Secondary end points: These were symptomatic nausea and fatigue as measured on a 0–10 VAS/ NRS. Patients were monitored at baseline just prior to surgery, 1 and 3 h post-operatively in the day surgery unit, while 1- and 7-day follow-up was done by phone. VAS was used in the day surgery unit, while NRS where used at follow-up by phone. CRP and cortisol levels were sampled for analysis before and 2 h after surgery. Perioperative data regarding length of surgery, pre-operative waiting period, post-operative mobilization and discharge, bile leakage, consultant/ junior surgeon, anesthetics, and morphine usage was recorded. Statistical analysis Sample size was calculated by collecting VAS scores for pain 3 h after surgery in 60 patients undergoing a standard LC with the same setup as in this study. The Mann–Whitney rank-sum test was used to detect a minimal difference between the two groups of 50% and types 1 and 2 errors of 0.05 and 0.20, respectively. Inclusion of 35 patients in each group was adequate according to the power calculation. The Mann–Whitney rank-sum test was used when evaluating difference in pain, fatigue, nausea, cortisol and CRP levels between the two groups. The chi-square (Fisher’s exact) test was used for dichotomized data. Post-hoc, the pre- to post-operative Soft music in laparoscopic cholecystectomy Fig. 1. Flowchart from inclusion to randomization. n = 93. changes of CRP and cortisol levels were tested using Generalized Linear Models. Two-tailed P-values of less than 0.05 were considered statistically significant. Statistical analyses were performed in STATA version 10.1 (StataCorp, College Station, TX, USA). Results are presented as per-protocol analysis, as we did not think that music would be the reason for admission after surgery or any malfunction of the mp3 player. Results Patient data During the study period, 204 consecutive patients underwent LC in our day surgery unit, 93 were enrolled in the study to compensate for likely dropouts. Five patients were excluded due to lack of randomization, four due to defect music pillow, one due to laparotomy and finally eight due to admission – five in the music group and three in the nonmusic group (Fig. 1). Data from 75 patients were analyzed, 40 patients randomized in the music group and 35 patients in the non-music group (Fig. 1). The groups had similar baseline characteristics (Table 1). The two groups received similar amounts of anesthetics and fluids during surgery and same amounts of morphine in recovery. Junior surgeons performed the majority of operations in both groups (Table 2). Pain, fatigue and nausea In the music group, no difference was found regarding the primary end point (VAS score 3 h postoperatively), but less pain was recorded at day 7. Furthermore, the music group experienced less fatigue at days 1 and 7 (Table 3). No differences were recorded in nausea. Table 1 Patient characteristics. Variable Music, n = 40 Non-music, n = 35 Gender, male/female Smokers, male/female BMI (kg/m2) Age (years) ASA (I/II) 12/28 3/13 27 (25–31) 50 (35–57) 28/12 8/27 4/12 26 (24–33) 44 (36–58) 25/10 Data are reported as number of patients, or medians and interquartile ranges. ASA, American Society of Anesthesiologists; BMI, body mass index. Cortisol/CRP Pre- and post-operative cortisol and CRP levels were not different in the two groups. In the music group, cortisol decreased after surgery from 428.5 to 348.0 nmol/l, while it increased in the non-music group from 443.5 to 512.0 nmol/l (Fig. 2). CRP did not change in the music group from 1.90 to 1.60 nmol/l and in the non-music group from 1.45 to 1.25 nmol/l (Fig. 3). Using Generalized Linear Models for the comparisons, findings were statistically significant when comparing the pre- to postoperative cortisol level changes between the two groups (P < 0.001), while that was not the case for CRP (P = 0.292). Mobilization/discharge data No differences were observed regarding surgery time, mobilization time, or discharge time even though patients in the non-music group waited longer pre-operatively than patients in the music group (122 vs. 90 min, P = 0.035) (Table 2). Discussion The main findings of this study show that soft music did not decrease post-operative pain 3 h after 3 M. Graversen and T. Sommer Table 2 Anesthetic and surgical factors. n = 75. Variable Surgical factors Surgery (min) Waiting (min) Mobilization (min) Discharge (min) Bile leakage Consultant surgeon Admissions Anesthetic usage Remifentanil (mg) Propofol (mg) Droperidol (mg) Isotonic NaCl (l) Morphine (mg) Music, n = 40 75 90 150 255 5 8 5 3.38 670.50 1.25 900 10.0 Non-music, n = 35 (63–99) (65–140) (115–190) (195–290) 75 122 155 237 9 5 3 (2.60–4.61) (576.25–890.75) (0.625–1.25) (500–1000) (5.3–15.0) 3.40 706.50 1.25 900 8.0 P-value (60–90) (80–157) (120–210) (200–285) 0.550 0.035* 0.643 0.551 0.235 0.552 0.723 (2.75–3.93) (591.25–890.50) (0.625–1,25) (500–1000) (3.5–10.0) 0.642 0.897 0.690 0.878 0.147 Data are reported as number of patients, or medians and interquartile ranges. *Statistically significant (P < 0.05). Table 3 Pain, fatigue and nausea at baseline and after surgery. Variable Pain (VAS 1–10) Baseline 1h 3h 1 day 7 days Fatigue (VAS 1–10) Baseline 1h 3h 1 day 7 days Nausea (VAS 1–10) Baseline 1h 3h 1 day 7 days Music, n = 40 Non-music, n = 35 P-value 0.00 3.00 2.00 3.00 0.00 (0.00–1.00) (1.00–5.00) (0.25–3.00) (1.00–5.00) (0.00–1.25) 0.00 3.00 2.00 3.00 1.00 (0.00–2.00) (2.00–4.00) (1.00–3.00) (2.00–5.00) (1.00–2.00) 0.537 0.927 0.207 0.542 0.014* 1.00 5.00 5.00 3.00 0.00 (0.00–3.00) (2.25–8.00) (3.00–7.00) (0.75–5.00) (0.00–1.25) 2.00 6.00 5.00 4.00 1.00 (0.00–4.00) (4.50–8.00) (3.00–7.00) (2.00–6.00) (0.00–3.00) 0.425 0.115 0.632 0.042* 0.015* 0.00 0.00 0.00 0.00 0.00 (0.00–0.00) (0.00–0.00) (0.00–0.00) (0.00–0.00) (0.00–0.00) 0.00 0.00 0.00 0.00 0.00 (0.00–0.00) (0.00–0.00) (0.00–0.00) (0.00–0.00) (0.00–0.00) 0.522 0.809 0.950 0.817 0.150 Data are reported as median and (interquartile range). *Statistically significant (P < 0.05). VAS, visual analog scale. surgery. However, decreased post-operative pain 7 days after LC, and fatigue 1 and 7 days after surgery were observed. Furthermore, there seemed to be a significant difference in the pre- to post-operative cortisol level in patients randomized in the music group compared with patients in the non-music group; however, this finding was based on post-hoc analysis, and final conclusions regarding these changes should be modest. As demonstrated in other studies,15 CRP did not change in the early period of laparoscopically induced surgical stress. Overall pain and fatigue levels in the two groups 4 were quite low, indicating that the impact of soft music may have minor clinical relevance in patients undergoing minimal invasive surgery. There was no difference in the level of pain during the stay in the day surgery unit as demonstrated by the equal VAS scores and use of analgesics. The fact that more patients in the non-music group had gallbladder lesion during surgery could have induced more pain; however, in case of gallbladder lesion during surgery, our routine is to clean up the abdomen completely by peritoneal lavage, thus minimizing additional pain. Soft music in laparoscopic cholecystectomy Fig. 2. Cortisol levels (nmol/l) before and 2 h after surgery in the two groups. n = 75 (40 exposed to music and 35 not exposed to music). Data are reported as medians and interquartile ranges. *Statistically significant (P < 0.001). Fig. 3. C-reactive protein (CRP) levels (nmol/l) before and 2 h after surgery in the two groups. n = 75 (40 exposed to music and 35 not exposed to music). Data are reported as medians and interquartile ranges. The non-music group waited longer for surgery, which may have caused higher levels of stress; however, pre-operative cortisol levels in the two groups were comparable. A recent study has demonstrated that post-operative pain may be associated with the length of waiting.16 Per protocol, we excluded patients who were admitted after surgery because we wanted to test soft music therapy in day surgery patients and admission could have a great impact on results, distorting the day surgery focus. There was no difference in admission rates between the two groups. Because we excluded admitted patients, we have no post-operative data on the admitted patients, making it impossible to evaluate any impact on outcome. We used only one type of music from Musicure®, which has been designed for use in perioperative settings and used in other studies.17 Sounds from the music pillow could be heard from a small distance. Therefore, we chose to randomize days and not patients, as the sound could have affected measurements of patients randomized to non-music group, lying in the same ward. Any discomfort known from headsets/earphones was also avoided by using the music pillow, as it allowed the patient to rest in different positions without decreasing the sound of music or shutting out the external sounds at the unit. The music pillow was tested and considered comfortable by the patients and staff prior to the study as well. Scoring the patients at days 1 and 7 was done blinded. However, we did not note if the patients made any remarks about the music to the nurse, which may have biased the scoring, but overall, the study design did not allow blinding. It has been shown in several randomized, clinical trials that pre- or post-operative music may decrease anxiety18,19,20 and thereby maybe also the level of the surgical stress response measured by reduced changes in cortisol level during/after surgery, as reported by Leardi et al.,8 Nilsson21 and Nilsson et al.22 However, as stated by Nilsson in a comprehensive review from 2008, this effect has only been documented in 50% of 42 randomized, clinical trials.18 There is no consensus whether music should be used pre-operatively, intraoperatively or postoperatively. We wanted to achieve the maximum effect from soft music, and therefore, our patients were exposed to music throughout the operation until discharge. The beneficial effects of music throughout the stay is demonstrated by BinnsTurner et al. in women undergoing mastectomy, where music reduces anxiety, mean arterial blood pressure and pain.23 Another factor that could have been of interest was the feedback from the patient and staff, allowing us to determine any changes of pain, anxiety or fatigue related to the music. If a patient or the staff disliked the music, it may have imposed stress and anxiety on the patient. Conversely, if the patient could choose the music genre, it may have reduced the level of stress, as demonstrated earlier.8 We tried to minimize any disapproval of the music genre, as 5 M. Graversen and T. Sommer we used music specifically developed to be soft and comfortable in a perioperative setting. The effect of music in humans is subject to ongoing investigation probably because of minimal adverse effects. The way music is affecting cerebral activity including moods is complex and not fully understood. It involves increasing the levels of neurotransmitters such as dopamine, glutamate and perhaps also noradrenaline, when listening to music. Dopamine levels affect moods, while glutamate is crucial in learning and memory functions.24 Särkämo et al. found that music influence the cerebral plasticity after stroke.25 Music has a powerful effect on our moods and emotions, and the calming and relaxing effect is used a great deal in commercial settings such as supermarkets, retail stores, Internet sites and the entertainment industry to make people feel comfortable and relaxed when waiting for a specific service. Waiting periods in the hospital are known to cause anxiety in patients undergoing surgery,26 and music may be a simple and cost-effective intervention that should be tested in well-designed randomized, clinical trials. Patient perceptions should be compared with objective data indicating surgical stress like cortisol, prolactin or interleukins previously used to measure stress in laparoscopic gallbladder surgery.15 In conclusion, we could not show that soft music decreased pain 3 h after LC; however, there may be an effect on the surgical stress causing a decrease in fatigue and later pain. Larger studies should be conducted with focus on changes in stress hormones as primary end points in combination with desired symptomatic effects from soft music in the perioperative setting. Acknowledgements The study was supported by J Klein og Hustrus Mindelegat. Conflict of interest: The authors have no conflicts of interest. References 1. Mühe E. Long-term follow-up after laparoscopic cholecystectomy. Endoscopy 1992; 24: 754–8. 2. Cervero F. Sensory innervation of the viscera: peripheral basis of visceral pain. Physiol Rev 1994; 74: 95–138. 3. Bisgaard T, Rosenberg J, Kehlet H. 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