A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay

A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay

European Journal of Oncology Nursing xxx (2014) 1e6 Contents lists available at ScienceDirect European Journal of Oncology Nursing journal homepage:...

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European Journal of Oncology Nursing xxx (2014) 1e6

Contents lists available at ScienceDirect

European Journal of Oncology Nursing journal homepage: www.elsevier.com/locate/ejon

A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay Kaina Zhou a, Xiaomei Li a, *, Jin Li a, Miao Liu d, Shaonong Dang b, Duolao Wang c, Xia Xin d a

Department of Nursing, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, PR China Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, PR China c Department of Medical Statistics, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, UK d Department of Nursing, First Affiliated Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, PR China b

a b s t r a c t Keywords: Breast cancer Music therapy Progressive muscle relaxation training Anxiety Depression Radical mastectomy

Purpose: To examine effects of music therapy and progressive muscle relaxation training on depression, anxiety and length of hospital stay in Chinese female breast cancer patients after radical mastectomy. Methods: A total of 170 patients were randomly allocated to the intervention group (n ¼ 85) receiving music therapy and progressive muscle relaxation training plus routine nursing care and the control group (n ¼ 85) receiving routine nursing care. Music therapy and progressive muscle relaxation training were performed twice a day within 48 h after radical mastectomy, once in the early morning (6a.m. e8a.m.) and once in the evening (9p.m.e11p.m.), for 30 min per session until discharged from the hospital. Results: A general linear model with univariate analysis showed that the intervention group patients had significant improvement in depression and anxiety in the effects of group (F ¼ 20.31, P < 0.001; F ¼ 5.41, P ¼ 0.017), time (F ¼ 56.64, P < 0.001; F ¼ 155.17, P < 0.001) and group*time interaction (F ¼ 6.91, P ¼ 0.009; F ¼ 5.56, P ¼ 0.019). The intervention group patients had shorter length of hospital stay (12.56 ± 1.03) than that of the control group (17.01 ± 2.46) with statistical significance (F ¼ 13.36, P < 0.001). Conclusion: Music therapy and progressive muscle relaxation training can reduce depression, anxiety and length of hospital stay in female breast cancer patients after radical mastectomy. © 2014 Elsevier Ltd. All rights reserved.

Introduction Breast cancer is the most common malignant tumor in the female population, with 1.40 million women diagnosed worldwide and 170,000 diagnosed in China (Zhang et al., 2013). Due to the negative consequences of a cancer diagnosis and the sequelae of

* Corresponding author. Department of Nursing, Xi'an Jiaotong University Health Science Center, No. 76 Yanta Western Road, Xi'an, Shaanxi, 710061, PR China. Tel./ fax: þ86 29 8265 7017. E-mail addresses: [email protected] (K.N. Zhou), roselee@ mail.xjtu.edu.cn (X.M. Li), [email protected] (J. Li), [email protected] (M. Liu), [email protected] (S.N. Dang), [email protected] (D.L. Wang), [email protected] (X. Xin).

cancer-related treatments, 20%e30% breast cancer patients suffer from depression and anxiety, which is significantly higher than the corresponding prevalence of depression and anxiety (6%e8%) in a € rneklett et al., 2012). In China, population of healthy women (Bjo the prevalence of anxiety, depression, or anxiety combined with depression in breast cancer patients accounts for 21.1%, 34.4% and 15.6%, respectively (So et al., 2010). The depressive and anxiety symptoms can persist for several years (den Oudsten et al., 2009), leading to adverse effects on the patient's quality of life, compliance to medical treatment, recurrence, survival as well as recovery from surgery during hospital stay (So et al., 2010; Ho et al., 2013; Wang et al., 2013). To improve anxiety and depression in female patients with breast cancer, many interventions are performed in this population,

http://dx.doi.org/10.1016/j.ejon.2014.07.010 1462-3889/© 2014 Elsevier Ltd. All rights reserved.

Please cite this article in press as: Zhou, K.N., et al., A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.07.010

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such as music therapy (Li et al., 2012; Lin et al., 2011; Zhou et al., 2011; Bulfone et al., 2009; Kenyon, 2007), relaxation training (Kovacic et al., 2013; Kova ci c and Kovacic, 2011; Kashani et al., 2012; Yoo et al., 2005), exercise (Ergun et al., 2013; Mehnert et al., 2011; Eyigor et al., 2010; Segar et al., 1998), cognitive-behavioral nursing € rneklett intervention (Yoo et al., 2009), supportive intervention (Bjo et al., 2012; Liao et al., 2010), laughter therapy (Cho and Oh, 2011), and others (e.g., melatonin, acupressure, or meditation) (Hansen et al., 2014; Genc and Tan, 2014; Kim et al., 2013). These interventions are used as one-pronged strategy and varied considerably in terms of methodology, sample size and settings; the two or more interventions with similar effects are rarely used simultaneously in the same sample of female breast cancer patients. Of the above mentioned interventions, music therapy and relaxation training have effects of improving anxiety and depression via mental relaxation and physical relaxation, respectively. Music therapy refers to the clinical and evidence-based use of music interventions to accomplish mental relaxation (de Niet et al., 2009). According to Chlan (2009), music can improve negative psychological states by occupying attention channels in the brain with meaningful, distractive and soothing auditory stimuli. Relaxation training is the intervention improving muscle relaxation of the whole body systematically and progressively (i.e., physical relaxation), which consequently reduces the level of depression and anxiety (Yoo et al., 2005). However, few randomized controlled trials consider the comprehensive effects of music therapy and progressive muscle relaxation training on anxiety, depression and rehabilitation in female patients with breast cancer after radical mastectomy. The purpose of the study was to examine the effects of music therapy and progressive muscle relaxation training on depression, anxiety and length of hospital stay (LHS) immediately following radical mastectomy in female patients with breast cancer. Findings of the study will be benefit to provide evidence for expanding the comprehensive use of music therapy and progressive muscle relaxation training to improve mental health and rehabilitation in female breast cancer patient population. Methods Design A randomized controlled trial design was used in the study. Setting The trial was conducted in the breast surgical department of oncology center of the general hospital affiliated to Xi'an Jiaotong University, China. The protocol was reviewed and approved by the Human Research Ethics Committee of Xi'an Jiaotong University. Participants Participants were in-patients with breast cancer. Based on the change in depression and anxiety scores (Wan et al., 2009; Bai and Li, 2012), 140 patients were needed to detect the difference between the two groups (70 in each group) with a power of 80% at the 5% level of statistical significance. To allow for 20% drop out, the sample size was increased to 170 patients. The patients were randomly allocated to two groups using 170 random numbers produced by computer software, with 85 in each group. Inclusion criteria were aged 25 to 65, female gender, diagnosed with breast cancer, and arranged to have radical mastectomy. If the patients had voice sensitive epilepsy, not preferred to music listening, or refused to give written informed consent, they were excluded.

Procedures The intervention group Based on routine nursing care, the intervention group patients received music therapy and progressive muscle relaxation training. Music therapy (music listening) was performed within 48 h after radical mastectomy and delivered by the researchers using MP3 players. The researchers were trained by a music therapist, including music selection, volume controlling, time arrangement of music listening and other matters of music therapy delivery. Two hundred and thirty songs were selected, including Chinese relaxation music, classical folk music, religious music and the music recommended by American Association of Music Therapy (AAMT). The patients selected their preferred music, controlled volume and listened through a headphone connected to the MP3 player. Music listening was twice a day, once in the early morning (6a.m.e8a.m.) and once in the evening (9p.m.e11p.m.), for 30 min per session until discharged from the hospital. During the time of postoperative hospital stay, the patients who did not adhere to music listening were given encouragement and assistance from the researchers. All intervention group patients received and completed music therapy as required. Progressive muscle relaxation training is the technique including continuous and systematic stretching and relaxing of the muscles until the whole body becomes relaxed (Lee et al., 2005). In this study, the patients were instructed how to contract and relax the 16 muscle groups on the second day after the surgery. The 16 muscle groups are right hand and forearm, right biceps, left hand and forearm, left biceps, forearm, upper section of cheeks and nose, lower section of cheeks and nose, neck and throat, chest, shoulders and upper part of back, abdominal region and stomach, right thigh, right calf, right foot, left thigh, left calf and left foot. Similar to music therapy, progressive muscle relaxation training was twice a day, once in the early morning (6a.m.e8a.m.) and once in the evening (9p.m.e11p.m.), for 30 min per session until discharged from the hospital. Therefore, the patients were encouraged to do muscle relaxation and music listening simultaneously. For those patients who felt pain while doing muscle relaxation in some muscle groups, they were instructed to focus on contracting and relaxing other muscle groups or to listen to the relaxation music, in order to alleviate pain. Progressive muscle relaxation training was conducted by the researchers in an orderly way and step by step according to the patients' condition until the patients did the training freely and easily without uncomfortable feelings. All intervention group patients attended and completed the training. To avoid confliction of the routine nursing care delivery, the researchers performed music therapy and progressive muscle relaxation training during 1p.m.e3p.m. for the first time, in that this time period was visiting time of the hospital and the researchers had enough time to instruct the patients in music listening and progressive muscle relaxation training step by step. The following instructions and supervisions of the two interventions were performed twice a day, once in the early morning (7a.m.e8a.m.) and once in the evening (8p.m.e9p.m.). To avoid contamination of the two groups, the researchers arranged the intervention and control group patients in different inpatient areas of the breast surgical department, i.e., the intervention group patients stayed in the area A, while the control group patients stayed in the area B. These areas were not close proximity. The control group The control group patients received routine nursing care, including vital signs observation, surgery district nursing, drainage tube nursing, function exercise of the surgical side and postoperative complication observation. They were not blinded

Please cite this article in press as: Zhou, K.N., et al., A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.07.010

K.N. Zhou et al. / European Journal of Oncology Nursing xxx (2014) 1e6

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regarding the music therapy and progressive muscle relaxation training in the intervention group.

0.80, test-retest reliability is 0.72 (Wong et al., 2001). In this study, Cronbach's a was 0.87.

Measures

Data collection

Zung self-rating depression scale (ZSDS) The Chinese ZSDS is a 20-item self-report measure evaluating the symptoms of depression. The patients rated each item with regard to how they had felt during the preceding week using a 4point Likert scale, with 4 representing the most unfavorable response. The sum of the 20 items produces a score ranging from 20 to 80, with higher score demonstrating greater depression (Passik et al., 2001). Overall, the Chinese ZSDS reliability is 0.92, validity is 0.84 (Mantani et al., 2007). In this study, Cronbach's a was 0.76.

Data were collected from March to December, 2013. Demographic data were collected on the day when the patient was admitted to the hospital (baseline); depression and anxiety were measured on the day before radical mastectomy (pre-test) and on the day before discharged from the hospital (post-test), respectively. Length of hospital stay (LHS) was calculated as the days from the first day after radical mastectomy to the day of discharged from the hospital. Data collectors were trained to complete the questionnaire by face-to-face interview and had no information about the group allocation.

State anxiety inventory (SAI) The Chinese SAI is a 20-item self-report scale using a 4-point Likert format (1 ¼ not at all, 4 ¼ very much so). The possible score ranges from 20 to 80, with higher score indicating greater anxiety (Barnason et al., 1995). Related studies on validation of the Chinese SAI show that validity is 0.88 (Shek, 1993), Cronbach's a is

Data analyses All statistical analyses were carried out using SPSS 20.0. Frequencies and percentages were used for categorical variables; mean and standard deviation (SD) were used for continuous

Fig. 1. Flow chart of the study.

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showed that the intervention group patients had significant improvement in depression and anxiety in the effects of group (F ¼ 20.31, P < 0.001; F ¼ 5.41, P ¼ 0.017), time (F ¼ 56.64, P < 0.001; F ¼ 155.17, P < 0.001) and group*time interaction (F ¼ 6.91, P ¼ 0.009; F ¼ 5.56, P ¼ 0.019) (Table 2). The average LHS of the total patients were 15.62 ± 3.30 (range: 11e21) days. On the day before discharged from the hospital, the intervention group patients had shorter LHS (12.56 ± 1.03) than that of the control group (17.01 ± 2.46) with statistical significance (F ¼ 13.36, P < 0.001) (Table 2). Correlations of depression (depression score difference, DSD), anxiety (anxiety score difference, ASD) and LHS were shown in Table 3. Significant correlations were found between DSD and ASD (r ¼ 0.457, P < 0.01), ASD and LHS (r ¼ 0.276, P ¼ 0.03) regarding the control group.

variables. Independent samples t-test and Chi-square test were applied to detect the differences of baseline data between groups. The change of depression and anxiety was regarded as the corresponding score differences between post-test and pre-test. A general linear model with univariate analysis was used to analyze the change of depression and anxiety in effects of group, time, and group*time interaction, and the difference of LHS between groups. Spearman correlation (r) was used to explore the relationships among depression, anxiety and LHS. A P-value of less than 0.05 was considered statistically significant (two sided). Results Of 176 patients screened for eligibility, 6 (3.4%) were excluded because they refused to participate (n ¼ 3), had a negative preference for music (n ¼ 2), or disliked sound (n ¼ 1). The remaining 170 patients were randomly allocated to the intervention group (n ¼ 85) and the control group (n ¼ 85). The intervention group patients received music therapy and progressive muscle relaxation training and the total patients completed the questionnaire survey (Fig. 1). The two group patients were similar in demographic characteristics at baseline (P > 0.05) (Table 1). There were two peaks of initial age of breast cancer occurrence, one was in 25e38 years, and the other in 43e65 years. Of the 170 patients, the depression score was 38.29 ± 6.40, the anxiety score was 53.98 ± 8.40. There were no significant differences of the pre-test depression and anxiety scores between the two groups (P > 0.05). These data were not tabulated. On the day before discharged from the hospital, depression and anxiety scores decreased to 32.65 ± 5.00 and 41.06 ± 6.43, respectively. A general linear model with univariate analysis

Discussion The study showed positive effects of music therapy and progressive muscle relaxation training on improving depression and anxiety in female patients with breast cancer following radical mastectomy via between-group comparison (group effect) and within-group comparison (time effect). Specifically, the interaction effects of the intervention and time was found in the present study. First, both group patients had lower depression and anxiety scores in the post-test than that in the pre-test, demonstrating that depression and anxiety relieved over time after radical mastectomy, that is, time was the influencing factor of depression and anxiety changes. Second, based on the impact of time, the intervention group patients had greater improvement in depression and anxiety, indicating that during a certain period (such as the similar

Table 1 Comparison of demographic characteristics of the patients (N ¼ 170) (n, %). Items

Total

Intervention group (n ¼ 85)

Control group (n ¼ 85)

Statistics

P-value

Age (years) (mean ± SD) Occupation Farmers Workers Teachers Others Education attainment Middle school and below High school and above Marital status Married Single/divorced/widow Spousal relationship Good General Bad Residence Urban Rural Individual monthly income (Chinese $) <1000 1000e3000 >3000 Operation procedure Extensive radical mastectomy Modified radical mastectomy Chemotherapy immediately after surgery Yes No Initially suffer from breast cancer Yes No Initial age of breast cancer occurrence (years) (mean ± SD)

47.01 ± 9.50

46.80 ± 9.37

47.13 ± 9.58

t ¼ 0.16

0.85

40 15 7 23

26 15 5 39

(30.6) (17.6) (5.9) (45.9)

c2 ¼ 4.65

0.59

66 30 12 62

(38.8) (17.6) (7.1) (36.5)

(47.1) (17.6) (8.2) (27.1)

50 (29.4) 120 (70.6)

26 (30.6) 59 (69.4)

24 (28.2) 61 (71.8)

c2 ¼ 5.85

0.21

126 (74.1) 44 (25.9)

65 (76.5) 20 (23.5)

61 (71.8) 24 (28.2)

c2 ¼ 1.57

0.72

90 (52.9) 45 (26.5) 35 (20.6)

47 (55.3) 22 (25.9) 16 (18.8)

43 (50.6) 23 (27.1) 19 (22.4)

c2 ¼ 5.97

0.40

110 (64.7) 60 (35.3)

53 (62.4) 32 (37.6)

57 (67.1) 28 (32.9)

c2 ¼ 0.59

0.62

59 (34.7) 87 (51.2) 24 (14.1)

27 (31.8) 42 (49.4) 16 (18.8)

32 (37.6) 45 (52.9) 8 (9.4)

c2 ¼ 6.47

0.17

18 (10.6) 152 (89.4)

8 (9.4) 77 (90.6)

10 (11.8) 75 (88.2)

c2 ¼ 0.65

0.56

146 (85.9) 24 (14.1)

76 (89.4) 9 (10.6)

70 (82.4) 15 (17.6)

c2 ¼ 3.80

0.11

105 (61.8) 65 (38.2) 43.56 ± 8.82

56 (65.9) 29 (34.1) 43.23 ± 8.80

49 (57.6) 36 (42.4) 43.45 ± 8.59

c2 ¼ 0.34

0.80

t ¼ 0.12

0.83

SD: standard deviation.

Please cite this article in press as: Zhou, K.N., et al., A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.07.010

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Table 2 Between-group comparison of depression and anxiety scores and length of hospital stay (days) (mean ± SD): a general liner model with univariate analysis.a Depression

Total (N ¼ 170) Intervention group (n ¼ 85) Control group (n ¼ 85) Group Time Group*time

Anxiety

LHS (days)

Pre-test

Post-test

Pre-test

Post-test

38.29 ± 6.40 37.47 ± 5.66 38.01 ± 6.65 F ¼ 20.31 P < 0.001 F ¼ 56.64 P < 0.001 F ¼ 6.91 P ¼ 0.009

32.65 ± 5.00 30.21 ± 3.31 33.40 ± 5.30

53.98 ± 8.40 50.97 ± 8.25 54.02 ± 8.76 F ¼ 5.41 P ¼ 0.017 F ¼ 155.17 P < 0.001 F ¼ 5.56 P ¼ 0.019

41.06 ± 6.43 34.01 ± 4.66 43.35 ± 6.00

15.62 ± 3.30 12.56 ± 1.03 17.01 ± 2.46 F ¼ 13.36 P < 0.001 e e e e

SD: standard deviation. LHS: length of hospital stay. a In the general liner model, independent variables were depression score, anxiety score, and LHS (days), respectively; group and time were fixed factors for analyzing depression and anxiety change in group, time, and group*time interaction effects, while group was fixed factor for analyzing the difference of LHS (days) between groups.

postoperative hospital stay of the two group patients), music therapy and progressive muscle relaxation training plus routine nursing care had more significant effects on relieving depression and anxiety than that of pure routine nursing care. In this study, the patients were encouraged to do muscle relaxation parallel with music therapy for the following reasons. First, music can reduce depression and anxiety by meaningful and soothing auditory stimuli (Chlan, 2009; Zhou et al., 2011; Li et al., 2012) and by relieving uncomfortable feelings such as pain (Li et al., 2011). Second, muscle relaxation can improve depression and anxiety by continuous and systematic stretching and relaxing of the muscles, that is, from physical relaxation to mental relaxation (Zhao et al., 2012; Rejeh et al., 2013). By combining the two interventions, the patients had great improvement in depression and anxiety. The intervention group patients had shorter LHS than that of the control group after music therapy and progressive muscle relaxation training. It is acknowledged that psychological states can impact on physical health and body function, especially in the patients who suffer from body image change or function lost after the treatment (e.g., breast cancer patients, cervical cancer patients) (Ho et al., 2013). In this study, the researchers performed music therapy and progressive muscle relaxation training based on routine nursing care to reduce depression and anxiety, which is benefit to the rehabilitation in function and physical health, and consequently to reduce the days of hospital stay. However, it is not consistent with the finding that music therapy has no significant effect on shortening length of hospital stay in elective abdominal surgery patients (Vaajoki et al., 2012). This is probably because of the different disease of the patients or different intervention strategy. Therefore, the effects of music therapy and progressive muscle relaxation training on length of hospital stay in patients with different diseases need further examination. With respect to the relationships among depression, anxiety and LHS, the significant correlations were found between

Table 3 Correlation of depression and anxiety score differences and length of hospital stay. Items

Intervention group (n ¼ 85)

Control group (n ¼ 85)

DSD

LHS

DSD

ASD

LHS

DSD ASD LHS

1 0.124 0.195

1

1 0.457** 0.095

1 0.276*

1

ASD 1 0.018

DSD: depression score difference. ASD: anxiety score difference. LHS: length of hospital stay. *P < 0.05. **P < 0.01.

depression (DSD) and anxiety (ASD), anxiety (ASD) and LHS regarding the control group. The positive correlation between DSD and ASD reveals that higher level of depression associated with higher level of anxiety, and vice versa. Meanwhile, the result also reflects that without music therapy and progressive muscle relaxation training, the control group patients had higher depression and anxiety scores in comparison with that of the intervention group patients. Chintamani et al. (2011) and Hill et al. (2011) also find similar results in their study. The negative correlation between ASD and LHS indicates that the low anxiety score difference associated with longer days of hospital stay, that is, those patients who had higher level of anxiety (post-test) had relative slower recovery in physical health and stayed more days in the hospital after the surgery, reflecting the influence of negative psychological states on physical rehabilitation. In clinical practice, it should provide target interventions according to the change of psychological states in female breast cancer patients to prevent the adverse impacts on physical rehabilitation. The correlation between DSD and LHP was not significant, which is probably because the depression symptoms were not severe enough to influence the patients' rehabilitation. Therefore, the correlation between depression and LHP needs further exploration. Regarding the intervention group, the positive correlation between DSD and ASD demonstrates that depression improvement associated with anxiety improvement, whereas the negative correlation between DSD or ASD and LHS indicates that the more significant improvement of depression or anxiety, the shorter length of hospital stay. It also confirms to the positive effects of music therapy and progressive muscle relaxation training on improving depression and anxiety. However, these correlations were not statistically significant, which is probably due to the relative small sample size (n ¼ 85). Thus, it needs further study on the correlation of depression, anxiety and LHS in a larger sample size of female patients with breast cancer under music therapy and progressive muscle relaxation training. There were some limitations of the study. First, it lacked of physiological data relating to depression and anxiety. Second, the improved anxiety and depression and reduced length of hospital stay in the intervention group patients may be due to the increased attention, which was not taken into consideration in the study. Third, the trial was conducted in Xi’an, which limited the generalization of the results to all female patients with breast cancer after radical mastectomy. In conclusion, depression, anxiety and LHS can be significantly reduced under music therapy and progressive muscle relaxation training. It is recommended that music therapy and progressive muscle relaxation training be used comprehensively in female patients with breast cancer following radical mastectomy.

Please cite this article in press as: Zhou, K.N., et al., A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.07.010

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Please cite this article in press as: Zhou, K.N., et al., A clinical randomized controlled trial of music therapy and progressive muscle relaxation training in female breast cancer patients after radical mastectomy: Results on depression, anxiety and length of hospital stay, European Journal of Oncology Nursing (2014), http://dx.doi.org/10.1016/j.ejon.2014.07.010