Effects of music therapy on pain among female breast cancer patients after radical mastectomy: results from a randomized controlled trial

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1 Breast Cancer Res Treat (2011) 128: DOI /s z CLINICAL TRIAL Effects of music therapy on pain among female breast cancer patients after radical mastectomy: results from a randomized controlled trial Xiao-Mei Li Hong Yan Kai-Na Zhou Shao-Nong Dang Duo-Lao Wang Yin-Ping Zhang Received: 30 December 2010 / Accepted: 16 April 2011 / Published online: 3 May 2011 Ó Springer Science+Business Media, LLC Abstract Music therapy has been used in multiple health care settings to reduce patient pain, anxiety, and stress. However, few available studies have investigated its effect on pain among breast cancer patients after radical mastectomy. The aim of this study was to explore the effects of music therapy on pain reduction in patients with breast cancer after radical mastectomy. This randomized controlled trial was conducted at the Surgical Department of Oncology Center, First Affiliated Hospital of Xi an Jiaotong University from March to November A total of 120 breast cancer patients who received Personal Controlled Analgesia (PCA) following surgery (mastectomy) were randomly allocated to two groups, an intervention group and a control group (60 patients in each group). The intervention group accepted music therapy from the first day after radical mastectomy to the third admission to hospital for chemotherapy in addition to the routine nursing care, while the control group received only routine nursing care. Pain scores were measured at baseline and three posttests using the General Questionnaire and Chinese version of Short-Form of McGill Pain Questionnaire. The primary endpoint was the change in the Pain Rating Index X.-M. Li K.-N. Zhou Y.-P. Zhang Department of Nursing, Xi an Jiaotong University College of Medicine, Xi an , People s Republic of China H. Yan (&) S.-N. Dang Department of Public Health, Xi an Jiaotong University College of Medicine, No. 76, Yanta Road West, Xi an , Shaanxi, People s Republic of China xjtu_yh.paper@yahoo.com.cn D.-L. Wang Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK (PRI-total) score from baseline. Music therapy was found to reduce the PRI-total score in the intervention group significantly compared with the control group with a mean difference (95% CI) of (-2.80, -1.95), (-2.85, -1.96), and (-2.33, -1.42) for the 1st, 2nd, and 3rd post-tests, respectively. Similar results were found for Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) scores. The findings of the study provide some evidence that music therapy has both short- and long-term positive effects on alleviating pain in breast cancer patients following radical mastectomy. Keywords Pain Music therapy Breast cancer Radical mastectomy Randomized controlled trial Introduction Breast cancer is one of the leading causes of death among women aged years and has increasingly become a significant public health burden due to its associated high morbidity, mortality, and tremendous health care costs [1, 2]. Globally, the incidence of breast cancer is on the rise and occurring more rapidly in countries with a low incidence rate [3]. Data from developed countries indicate that one out of every eight women is likely to develop breast cancer [1, 2]. Despite the low morbidity of breast cancer, China has the largest breast cancer population in the world, and the annual increasing rate is about 1 2% higher than the world average [4]. Breast cancer treatment usually begins with surgery followed by various combinations of adjuvant therapies involving radiation therapy, chemotherapy as well as hormone therapy [5]. A substantial number of women who undergo surgery for breast cancer develop chronic pain and

2 412 Breast Cancer Res Treat (2011) 128: the estimated incidence rate ranges from 20 to 50% [6, 7]. Chronic pain which follows breast cancer surgery can cause considerable physical disability and psychological disturbances [8]. Thus, it is important to control the level of pain for patients with breast cancer. Studies on the effects of music therapy on pain in cancer patients with various diagnoses have revealed numerous benefits including increased comfort and relaxation with reduced self-reported pain, anxiety, treatment-related distress, nausea, and vomiting [9]. It is also reported that patients may benefit from music therapy which directly alleviates pain in patients via specific physiological, psychological, and socioemotional mechanisms [10]. With reference to the direct physiological effects, music therapy changes neuronal activity with entrainment to musical rhythms in the lateral temporal lobe and cortical areas devoted to movement. Music therapy has also been shown to have an effect through mu opiate receptor expression, morphine-6 glucuronide, and interleukin-6 levels [11]. Music therapy also benefits the patients through its effect on caregiver attitudes and behaviors [10]. However, the magnitude of the efficacy of music therapy varies between studies. For example, some researchers suggested that music therapy alleviates pain for cancer patients [12], whereas others show very little effect after music therapy [13]. Very few studies investigating music therapy on pain in breast cancer patients after radical mastectomy are available. This article reports a randomized controlled trial to assess the effects of music therapy on pain relief among 120 breast cancer patients after radical mastectomy. Methods Study setting The trial was conducted at the Surgical Department of Oncology Center, The First Affiliated Hospital of Xi an Jiaotong University College of Medicine from March to November The protocol was reviewed and approved by the Human Research Ethics Committee of the Xi an Jiaotong University College of Medicine. Patients The target population was patients with breast cancer admitted to the surgical department of oncology at a comprehensive hospital in China. The sample size was calculated based on the change in PRI-total score [14]. It was estimated that 100 patients (50 in each group) were required to detect a difference of 1.5 in PRI-total score with a power of 80% at the 5% level of statistical significance. The sample size was augmented to 120 patients to allow for 20% drop out. Those patients were randomly allocated to two groups using a randomization code generated by computer software with 60 in each group. Inclusion criteria required female patients aged between 25 and 65 years with pathologic diagnosis of breast cancer who needed to have radical mastectomy (including modified radical mastectomy [MRM] and extensive radical mastectomy [ERM]). Patients who were allergic to sound or had the voice sensitivity of epilepsy or did not prefer to listen to music were excluded. All patients received Personal Controlled Analgesia (PCA) after radical mastectomy. Procedures The intervention group Patients in the intervention group were given an introduction of the 202 music names and four types of music in the music media library stored on MP3 players. The music therapy was delivered by a trained researcher. Consent forms were signed by patients before intervention started. The patients in the intervention group were instructed to select their preferred music, control the music volume and listen through a headphone connected to the MP3 player. Total intervention time involved the hospital stay after radical mastectomy (average 13.6 ± 2.0 days) and the two chemotherapy periods (each with an average of 18.9 ± 7.1 days). Patients were instructed to listen to music twice a day (30 min per session), once in the early morning (6 a.m. 8 a.m.) and once in the evening (9 p.m. 11 p.m.). During the time of postoperative hospital stay if a patient missed a music listening session, she was encouraged by the researcher to adhere. Once patients were discharged from hospital they were followed-up by the researcher through a telephone call. The control group Patients in the control group were not blinded regarding the music therapy in the intervention group and took part in four tests (one at baseline and three at post randomization). Music media library The music media library, which based on the effects of different types and modes of music treatments effects [15, 16] and according to the characteristics of Pentameter Therapy Principle and different tonality [17], was designed and compiled by three experts (one music therapist, one musician, and one oncologist) and the researchers. A total of 202 items of light music was selected, falling into four types: classical Chinese folk music, popular world music,

3 Breast Cancer Res Treat (2011) 128: the music recommended by the American Association of Music Therapy (AAMT), and Chinese relaxation music. All of the music files were copied to the MP3 players. Measures Demographic characteristics A standard questionnaire was used to collect demographic data at baseline, including age, occupation, education level, residence, monthly income, marital status, age at the first suffering from breast cancer, and others. Pain The Chinese version of Short-Form of McGill Pain Questionnaire (SF-MPQ), which measures the quantitative and qualitative experiences of pain, was applied to evaluate the pain level of breast cancer patients following radical mastectomy. The SF-MPQ closely correlates to the pain indices of the long form in various populations and cancer patients [18] and has been widely used to assess pain in breast cancer patients [19]. The SF-MPQ recognizes the temporal characteristics of the symptom by describing the time of appearance after surgery, the timing of its occurrence, and its relationship with movements. Additionally, it involves a body outline drawing for the evaluation of pain location. The SF-MPQ form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale where 0 = none, 1 = mild, 2 = moderate, or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective, and total descriptors. The SF-MPQ also includes a visual analogue scale (VAS) and the Present Pain Intensity (PPI) of the standard MPQ. The Visual Analogues Scale (VAS) is the index measured by a ruler scaled from 0 to 10 cm (the larger the number, the more serious the pain), which was further scaled as four levels (mild pain = 0 2, moderate pain = 3 5, severe pain = 6 8, and the most serious pain = 9 10) [20]. The Present Pain Intensity (PPI) has sixlevels scaled from 0 to 5 (0 = no pain, 1 = mild discomfort, 2 = discomfort, 3 = uncomfortable, 4 = terrible pain, and 5 = extremely painful) [21, 22]. The Chinese translation of the attributes provided by the validated Italian version of the MPQ was used. The validity coefficient of SF-MPQ is 0.77 [23]; the test retest reliability coefficient of SF-MPQ is 0.75 [24] and [25]. Alpha reliability coefficient of SF-MPQ in this study was Pain levels were evaluated at baseline (the first day after radical mastectomy (pre-test)), on the day before discharge from hospital (1st post-test), and on the days of admission to hospital for the first and second chemotherapy sessions (2nd and 3rd post-tests, respectively). Due to different regimens of chemotherapy, the average intervals between different follow-up visits were 14, 21, or 28 days. The trained researcher interviewed patients and filed the questionnaire. Data analysis Data management was performed using Epi Data version 3.1. The primary endpoint was the change in the score of PRI-total from baseline with the secondary endpoints being the changes in the components of PRI-total (Sensory, Affective and Word count), VAS, and PPI from baseline. These outcome variables were analyzed by a linear mixed effect model taking into account repeated measurements. In this model, the baseline measurement of each pain level was treated as a covariate. Treatment, time, and interaction between time and treatment were treated as fixed effects, whereas the patient was treated as a random effect. During the trial, some patients were lost to follow up, resulting in some incomplete observations. These incomplete observations were not imputed but were assumed to be missing at random in the model analysis. The estimated within- and between-treatment differences from the model were therefore reported together with their 95% confidence intervals (CI). Reported P values were two-sided, and a P value of \0.05 was considered statistically significant. All statistical analyses were carried out using the Stata/SE version 9.0 (StataCorp LP, USA). Statistical analyses were performed on intention to treat basis. Results Of 128 patients screened for eligibility, 8 (6.25%) were ineligible due to various reasons, including 3 for negative preference for music, 1 for allergy to sound, 3 for refusing to participate, and 2 for other reasons (Fig. 1). 120 patients were randomly allocated to the intervention group and control group, with 60 patients for each group. No patients from the intervention and control group were lost in the first post-test; 54 patients remained in the intervention group (6 patients lost) and 51 patients remained in the control group (9 patients lost) at the second and third posttests, respectively (Fig. 1). The demographic characteristics of the patients are shown in Table 1. The patients in the two groups are comparable in terms of age, occupation, education level, residence, and monthly income. Pre-test and comparison of pain For all patients, the PRI-total score was found to be 8.12 ± The scores for PRI-sensory, PRI-affective,

4 414 Breast Cancer Res Treat (2011) 128: Recruitment to the clinical trial of music therapy Experimental group n=60 Music therapy and routine nursing care 1st post-test: (n=60) Lost to follow-up (n=0) 2nd post-test (n=54) Lost to follow-up (n=6) 3rd post-test (n=54) Lost to follow-up (n=6) 60 included in the analysis Assess for eligibility (n=128) Randomized allocation and word count were 4.05 ± 1.68, 4.07 ± 1.67, and 5.35 ± 1.64, respectively. VAS score was found to be 4.49 ± 1.08 and PPI score was 2.65 ± Between-group comparisons of PRI-total (t =-1.49), PRI-sensory (t =-7.62), PRI-affective (z =-1.83), word count (t =-1.00), VAS (t =-0.59), and PPI (t =-1.35) indicated no significant differences (P [ 0.05). Change in pain scores Pre-test Fig. 1 Flow chart of the study Control group n=60 Excluded (n=8) negative preference for music (n=2) allergy to sound (n=1) refuse to participate (n=3) other reasons (n=2) Routine nursing care 1st post-test: (n=60) Lost to follow-up (n=0) 2nd post-test (n=51) Lost to follow-up (n=9) 3rd post-test (n=51) Lost to follow-up (n=9) 60 included in the analysis Significant improvements from baseline in all indices for pain measurement were observed throughout the intervention period in both intervention and control groups from 1st post-test to 3rd post-test (Table 2). A significant difference in improvement from baseline between groups was observed at each point of post-test after controlling for baseline effect. For the primary endpoint (the PRI-total score), significant improvement was observed in the intervention group compared with the control group at the first post-test (P \ 0.001; difference between groups: -2.38; 95% CI: to -1.95) (Table 3). Although, at the third post-test, the difference between the two groups had diminished, it did still persist (P \ 0.001; difference between groups: -1.87; 95% CI: to -1.42) (Table 3; Fig. 2a). The other indices followed a similar trend to that observed with PRI-total. The index of word count was improved in the intervention group compared with the control group at the first post-test (difference between groups: -2.22; 95% CI: to -1.82) which was maintained until the last post-dose test (difference between groups was -1.86; P \ 0.001; 95% CI: to -1.44) (Table 3). Significant improvement in VAS was also found in the intervention group compared with the control group at the first post-test (P \ 0.001; difference between groups: -0.83; 95% CI: to -0.64) which continued up to the last post-dose test (difference between groups was (P \ 0.001; 95% CI: to -0.44) (Table 3; Fig. 2b). The PPI values also demonstrated a similar difference between the two groups at the first post-test (P \ 0.001; difference between groups: -0.79; 95% CI: to -0.62) and at the last post-test (difference between groups was (P \ 0.001; 95% CI: to -0.38) (Table 3; Fig. 2c). Discussion This article presents the findings of a randomized controlled trial of music therapy on female breast cancer patients after radical mastectomy, which shows significant pain alleviation in terms of PRI-total, VAS, and PPI scores. The results indicate that music therapy is a feasible and effective non-pharmacological intervention. Pain status of female breast cancer patients after radical mastectomy at baseline Pain is a multidimensional experience defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage [26]. Radical mastectomy can damage the nerves innervating the breast and surrounding tissue, particularly those supplying the deep musculature of the chest wall and those richly innervating breast skin and nipples, thus causing chronic post-surgical pain [21]. In this study, 85.8% of breast caner patients reported pain at baseline. The baseline PPI score observed in this study also showed that the pain feelings of patients were classified between discomfort and uncomfortable. In a survey study of 568 patients, 38.5% patients reported postoperative pain after breast cancer surgery [21]. These discrepancies may result from operation types, patients, races, and measuring techniques. Effects of music therapy on pain This study shows that music therapy reduced the three main pain scores (PRI-total, VAS, and PPI) significantly at all three post-tests. These results were consistent with

5 Breast Cancer Res Treat (2011) 128: Table 1 Demographic characteristics of the patients at baseline (n = 120) Variables Total number (120) Experimental group (60) Control group (60) n % n % n % Age (year) (mean ± SD) ± ± ± 9.48 Occupation Peasants Workers Cadres Teachers Medical staffs Others Education level Below middle school High school Associate degree Baccalaureate and above Residence Urban Rural Monthly income (RMB) \ [ Terms of payment Self-payment Free medical care Others Marital status Single Married Widow Divorce Spousal relationship Best Better General Worse Worst Have children or not Yes, single Yes, two Yes, more than three None Relationship with children Best Better General Operation type Extensive radical mastectomy Modified radical mastectomy

6 416 Breast Cancer Res Treat (2011) 128: Table 1 continued Variables Total number (120) Experimental group (60) Control group (60) n % n % n % Chemotherapy Yes No Period of chemotherapy (days) First suffering from BC Yes No Age at the first suffering from BC (mean ± SD) ± ± ± 8.28 previous studies showing the beneficial effects of music therapy after surgery [27, 28]. In a randomized controlled trial of 150 patients undergoing inguinal hernia or varicose vein surgery, Siedliecki and Good reported that patients in the intervention group had significant pain reductions compared with the control group [29]. There are a number of possible mechanisms by which music therapy alleviates pain. The gate control theory of pain put forward by Melzack and Wall suggests that pain impulses are transmitted from the site of an injury via the spinal cord to the brain, where the actual pain perception is generated [30, 31]. Neural gates in the spinal cord may be opened or closed to varying degrees, thus allowing more or fewer of those pain impulses to transmit through to the brain [32]. If control gates are blocked due to some factors, then the perception of the pain may be reduced. One of these factors in blocking gates could be messages descending from the brain via the efferent pathways in spinal cord. Music therapy could be these descending messages, resulting in fewer pain impulses reaching our conscious awareness [33]. Music therapy can also act as a mental attention distracting device via modifying the transmission of potentially painful impulses in the spinal cord. Another role of music therapy may be to provide competing stimuli for other peripheral nerve impulses such as those related to pain that may travel to, and be processed by, the brain via the spinal cord. Music therapy thus provides input into the central nervous system which attends more to the music than the pain [34]. The pleasant and familiar stimulus of music may work as a masking agent to cover over unwanted environmental stimuli in a hospital, which then relaxes muscles, distracts thoughts from pain and illness, evokes an affective response, and via descending nerve fibers closes the gate to perception of the sensory and affective components of pain [35]. Both of these effect areas (distraction and masking) may work together with physiological effects of music therapy and may be beneficial to the patients in enhancing their own relaxation process. As music is pleasant and noninvasive, it is a useful and safe non-pharmacological intervention for patients to consider. Music therapy has been shown to have several advantages over analgesics: it improves anxiety and depression, increases a sense of power, and adds no side effects [36]. Choice of music may be important for pain relief in China, despite findings to the contrary in the Cochrane review [37]. This study indicated that more than half of the patients prefer Chinese music. They reported that their preferred music could help them relax and distract themselves from pain. Most of the patients selected Chinese music, though over a fourth selected American music. Moreover, nearly two-thirds of patients reported falling asleep during music, supporting its sedative effect. At the last post-test interview, one-third of patients said that songs that were/have been a part of their life would be the most distracting or relaxing for their pain. This may be why most chose Chinese songs or Buddhist music. Other studies conducted in Taiwan, Korea, and USA have shown that culturally familiar music was chosen but that they were similar in their effects on pain [38] and sleep [39]. These findings suggest that culture and familiarity may affect the choice of music. Furthermore, if patients are to use the music on a long-term basis to help control chronic pain it is important for them to like the music they listen to. These observed therapeutic effects further justify the observation that listening to music can distract the attention of patients from the noisy environment and reduce negative stimuli. Moreover, the uncomfortable feelings such as pain and tension can be reduced during the process of music enjoyment. Influenced by the characteristics of music, the combination of physical, psychological, and emotional

7 Breast Cancer Res Treat (2011) 128: Table 2 Results from mixed model analysis of change in pain scores from baseline: within group comparison Pain indices Baseline (mean ± SD) 1st post-test (mean ± SD) Change between baseline and 1st post-test (95% CI) 2nd post-test (mean ± SD) Change between baseline and 2nd post-test (95% CI) 3rd post-test (mean ± SD) Change between baseline and 3rd post-test (95% CI) Intervention group n = 60 n = 60 n = 54 n = 54 PRI-total 7.62 ± ± (-6.07, -5.47) 1.72 ± (-6.59, -5.97) 0.71 ± (-7.61, -6.99) PRI-sensory 3.93 ± ± (-3.08, -2.72) 1.24 ± (-2.99, -2.61) 0.61 ± (-3.61, -3.24) PRI-affective 3.68 ± ± (-3.05, -2.67) 0.48 ± (-3.67, -3.28) 0.09 ± (-4.07, -3.68) Word count 5.20 ± ± (-3.34, -2.79) 1.80 ± (-3.794, -3.21) 0.70 ± (-4.89, -4.30) VAS 4.43 ± ± (-3.65, -3.36) 0.56 ± (-4.08, -3.77) 0.09 ± (-4.54, -4.24) PPI 2.58 ± ± (-2.18, -1.94) 0.20 ± (-2.57, -2.31) 0.02 ± (-2.19, -1.93) Control group n = 60 n = 60 n = 51 n = 51 PRI-total 8.50 ± ± (-3.69, -3.10) 4.17 ± (-4.19, -3.55) 2.62 ± (-5.74, -5.10) PRI-sensory 4.17 ± ± (-2.31, -1.95) 1.86 ± (-2.37, -1.99) 1.19 ± (-3.04, -2.65) PRI-affective 4.33 ± ± (-1.45, -1.08) 2.31 ± (-1.92, -1.52) 1.43 ± (-2.80, -2.40) Word count 5.50 ± ± (-1.13, -0.57) 4.18 ± (-1.48, -0.88) 2.62 ± (-3.03, -2.43) VAS 4.55 ± ± (-2.82, -2.53) 1.33 ± (-3.31, -3.00) 0.76 ± (-3.87, -3.56) PPI 2.72 ± ± (-1.39, -1.15) 1.00 ± (-1.76, -1.50) 0.57 ± (-2.19, -1.93) Note: Mixed model was used for the analysis of change in pain scores from baseline with baseline measurement of pain score as covariate, treatment, time, treatment and time interaction as fixed effects, and patient as random effect

8 418 Breast Cancer Res Treat (2011) 128: Table 3 Results from mixed model analysis of change in pain scores from baseline: between group comparison Pain indices 1st post-test difference (95% CI) 2nd post-test difference (95% CI) 3rd post-test difference (95% CI) PRI-total (-2.80, -1.95) (-2.85, -1.96) (-2.33, -1.42) PRI-sensory (-1.02, -0.52) (-0.89, -0.35) (-0.85, -0.31) PRI-affective (-1.85, -1.32) (-2.04, -1.48) (-1.55, -0.99) Word count (-2.61, -1.82) (-2.73, -1.89) (-2.28, -1.44) VAS (-1.04, -0.64) (-0.99, -0.55) (-0.89, -0.44) PPI (-0.96, -0.62) (-0.99, -0.62) (-0.75, -0.38) Note: Mixed model was used for the analysis of change in pain scores from baseline with baseline measurement of pain score as covariate, treatment, time, treatment and time interaction as fixed effects, and patient as random effect A Main Change in PRI-total B Main Change in VAS C Main Change in PPI Baseline 1st post-test 2nd post-test 3rd post-test Follow-up time Intervention group Control group Baseline 1st post-test 2nd post-test 3rd post-test Follow-up time Intervention group Control group Study limitations The study has a number of limitations. Firstly, the data were self-reported and could have been influenced by numerous factors, such as defensiveness, misrepresentation, personal emotions, and attitudes. Secondly, we used only quantitative research in this study for quantifying the intervention effects of music therapy. Focus group method could have been used to collect individual experiences with music therapy. Thirdly, no biomarkers or physiological measurements were done, which need to be further explored. A further shortcoming is that the assessor was not masked regarding patient allocation. Finally, the results of this single-center study may affect the external validity and applicability of the findings to other centers. In conclusion, the results of this randomized controlled trial suggested that pain was a common symptom among female breast cancer patients after radical mastectomy. After music therapy, the three main pain scores in the intervention group were reduced considerably up to 2 months after radical mastectomy. Therefore, it is suggested that music therapy is feasible and effective for relieving pain in female breast cancer patients after radical mastectomy. Music therapy could be considered as an adjunctive therapy for female breast cancer patients. Acknowledgments We are grateful to Professor Wei-Jun Yang for helping to establish the music media library and for instructing the delivery of music therapy. We thank the Dreyfus Health Foundation, New York for funding this study. Baseline 1st post-test 2nd post-test 3rd post-test Follow-up time Intervention group Control group Fig. 2 Effects of music therapy on pain The authors declare that they have no com- Conflict of interest peting interests. References comfort can be achieved, and finally pain sensitivity can be reduced. It is suggested that future research is needed to investigate how specific elements of music contribute to pain relief. 1. Avci IA, Gozum S (2009) Comparison of two different educational methods on teachers knowledge, beliefs and behaviors regarding breast cancer screening. Eur J Oncol Nurs 13: Puig A, Lee SM, Goodwin L et al (2006) The efficacy of creative arts therapies to enhance emotional expression, spiritually, and

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