ORIGINAL ARTICLE

The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial Tahereh Najafi Ghezeljeh, PhD,* Fatimah Mohades Ardebili, MSc,† Forough Rafii, PhD,‡ and Hamid Haghani, MSc§

This study was aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest–posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researchermade tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients’ preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after intervention in music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P < .001). No differences were detected in the mean scores of physiologic measures between groups before and after music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach. (J Burn Care Res 2015;XXX:00–00)

Burn injury is one of the most painful types of trauma.1 Burn injury pain is a challenging issue from acute to rehabilitation phase.2 It is related to stimulation of local nociceptors by inflammatory response and releasing of chemical mediators after burn From the *Center for Nursing Care Research, Department of Critical Care Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran; †Department of Medical-Surgical Nursing, Faculty of Nursing and Midwifery, Iran University of Medical Sciences, Tehran; ‡Center for Nursing Care Research, Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran; and §Statistic and Mathematics Department, School of Health, Iran University of Medical Sciences, Tehran. This study was part of a research project which is granted by Center for Nursing Care Research at Iran University of Medical Sciences (grant 90-03-123-15128). Address correspondence to Tahereh Najafi Ghezeljeh, PhD, Center for Nursing Care Research, Department of Critical Care Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Valiasr Street, Tehran, Iran. Email: [email protected] Copyright © 2015 by the American Burn Association 1559-047X/2015 DOI: 10.1097/BCR.0000000000000266

injury.3 The main factors influencing pain intensity included burn size, depth and location, psychological issues, inflammation, healing progression, and grafting.4 According to previous studies, there are interrelationships between pain and anxiety.1,5 Anxiety is the most common affective response related to burn injury, and its treatment is problematic.6 Pain5,7,8 and anxiety activate the autonomic nervous system and results in releasing catecholamine,7 which in turn provokes the changes in blood pressure and heart rate and other physiologic measures.9 These physiological events could have negative consequences (eg, increasing muscle nociception and tension) for burn patients with hypermetabolism and hemodynamic instability.5 Furthermore, anxiety can increase the pain perception and cause poor compliance with therapies.10 Stress as a result of experiencing pain can increase the secretion of immunosuppressive substances,11 which in turn will worsen the immunity of burn patients. Indeed, pain management is critical not only for humanistic reasons but also for its detrimental effects on physiological 1

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processes.10 It is believed that effective pain management can prevent posttraumatic stress disorder and increase patients’ self-esteem.12 Management of burn pain and its related anxiety varies according to its type. Burn pain and anxiety are classified to background, procedural, and breakthrough types.3 Background pain and its related anxiety have been defined as feeling pain or anxiety caused by illness during resting.1,3,4 The nature of background pain is continuous and prolonged.13 Pharmacological treatments are mainstay for reducing pain and anxiety, and opioids are the primary medicines for pain management of burn injury.7 However, the safety of using these substances in burn patients is problematic because of burn patients’ hemodynamic instability and hypermetabolism,13 deteriorating immune system,4,12 and the adverse effects of opioids on limiting patients’ activity. Also administrating low doses of opioids cannot completely manage pain.1 In recent decades, combinations of pharmacological treatments and complementary therapies for managing pain have received special attention globally.12,14,15 Music as a simple complementary therapy can be applied by nurses easily and without a need for high-level training. Music can be used as an approach for improving people’s wellness.16 It can be considered as a self-management intervention to decrease distress.17 It may induce relaxation by masking or distracting ones’ attention from negative stimuli or stress or interfere with autonomic nervous system.18 It has beneficial impacts on neurohormonal and immune system activities (eg, increasing immunoglobulin A level), regenerative processes,18,19 and emotional responses.18,20 Music is available, feasible, and portable, and patients’ preferences can be considered.21–23 It is essential that nurses investigate the effects of complementary therapies.24 Several studies have found that music reduces postoperative pain. In some of these studies,25–27 researchers found that music intervention was effective on well-being outcomes. However, most of the studies on burn patients have focused on procedural pain.1,28 Although there is evidence regarding the effectiveness of music intervention on reducing postoperative and procedural pain and related anxiety, there is no clear evidence about the effectiveness of this intervention for background pain in burns. This study was aimed to investigate the effect of music on background pain, anxiety, and relaxation levels in hospitalized burn patients.

METHODS This pretest–posttest randomized controlled clinical trial was performed in Motahari Burn and

Reconstructive Center affiliated to Iran University of Medical Sciences in Tehran, Iran. The sample size was estimated 50 subjects for each music intervention and control groups (power 80% and confidence interval 95%). Through convenience sampling method, 100 Iranian hospitalized burn patients were recruited between December 2013 and April 2014. The sample included adult patients who 1) had no respiratory injury, 2) after 72 hours of burn injury, 3) had background pain, 4) were able to communicate, and 5) had no hearing impairment. The exclusion criteria were 1) deterioration of patient’s condition and 2) participation in less than all three sessions of the study. Subjects were assigned to music and control groups through simple randomization.

Instruments Three researcher-made forms were used to record demographic and clinical characteristics and also using analgesics and physiologic measures by a blind coresearcher. To assess pain, anxiety, and relaxation levels, three visual analog scales (VASs) were used. Patients rated their pain, anxiety, and relaxation levels on three separate VAS scored from 0 (no pain/ no anxiety/quiet relaxing) to 100 (worst pain/highest anxiety level/no relaxation). The VAS has been reported as a reliable and valid scale to measure anxiety29 and pain.30 It has been frequently used to assess pain in different studies to investigate the effects of music intervention.31

Ethical Consideration Ethical approval was granted from research ethical committee of Tehran University of Medical Sciences (Reference: 2012/56689). Confidentiality and anonymity were guaranteed throughout the study. Informed consent form was signed by all patients who met the inclusion criteria. Participants also gave verbal agreement to receive music intervention before each session.

Procedure This study is part of a more extensive research that has been registered in the Iranian Registry of Clinical Trials (Code No: 201202269143N1). A flow diagram of the study is shown in Figure 1. In orientation day, demographic and clinical characteristics of patients and their use of analgesics were determined by a brief interview and using medical records. It is worthy of mention that the patients were receiving some analgesics (opioid and/or nonopioid), which have been prescribed by attending physicians as a routine basis. Then, patients in music intervention

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Journal of Burn Care & Research Volume XXX, Number XXX

Najafi Ghezeljeh et al  3

Initial day

Eligible and consent granted (n=100)

Screen for eligibility criteria (n=155): 1) Had no respiratory injury 2) Were not in acute phase of burn injury 3) Had background pain 4) were able to communicate 5) Had no hearing impairment

Random allocation

Music intervention (n=50)

Control group (n=50)

Repeated in 3 consecutive days

Gathering baseline information

Gathering outcome data-pre-intervention

Music intervention (n=50)

No intervention (n=50)

Gathering outcome data-post-intervention

Figure 1.  A flow diagram of the study.

group were asked to introduce their preferred music to be prepared by researcher. In next day for a total of 3 consecutive days, before and after intervention, physiologic measures of patients in two groups were measured and documented by coresearcher. The physiologic measures were included brachial pulse rate, respiration rate, and systolic and diastolic blood pressures. They were assessed while patient was in a supine position. The patient’s brachial pulse rate was counted for a minute, and then without removing hand from the patients’ pulse, respiration rate was controlled for a minute. Blood pressure was monitored by portable analog sphygmomanometer through auscultation by coresearcher. Also before and after intervention, patients in both groups were asked to rate their pain, anxiety, and relaxation levels on each specified VAS in 3 consecutive days. The average use of analgesics in these days was assessed by coresearcher. Music intervention was offered once a day for 3 consecutive days. The music intervention was conducted on patients’ bedside. They listened to self-selected music by headphone with their preferred volume. In this study, we prepared different

musical genres for providing options for patients to choose their preferred music. They selected different musical genres, including new age, Iranian traditional music, and classical music, and they listened to their selected music for 20 minutes. There were not any differences in length of time and type of music between days. Patients were asked to close their eyes and focus on the music and make them relax. By coordinating with health care providers and closing the door, researchers declined interferences and facilitate patients’ relaxing. In three sessions, the control group did not received music intervention and only received routine care.

Data Analysis Data were analyzed using SPSS-PC (V. 20.0). The level of significance was set as below .05. The average score of patients’ pain, anxiety, and relaxation levels and also their use of analgesics and physiologic measures in 3 consecutive days were considered for data analysis. Descriptive analysis was used for all variables. The study groups were compared with regard to demographic and clinical characteristics;

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pain, anxiety, and relaxation levels; use of analgesics; and physiologic measures by χ2 test, Fisher’s exact test, and independent t-test. For comparing pain, anxiety, and relaxation levels and physiologic measures within groups, paired t-test was used.

RESULTS All the patients in both groups completed the scales, and there were no missing data. Patients’

demographic information and clinical characteristics are presented in Table 1. One hundred adult patients participated in the current study. In both groups, most of them were male, married, employed, and under diploma. The mean score of participants’ age was 31.18 years (SD = 8.43, ranged from 18 to 48 years) in control group and 31.08 years (SD = 8.11, ranged from 18 to 48 years) in music intervention group. The participants did not have baseline anxiety disorder and did not use drugs for cardiac

Table 1. Demographic information and clinical characteristics of burn patients in music and control groups Groups Variables Demographic  Age, yr  Sex   Female   Male  Marital status   Single   Married  Occupation   Nonemployee   Employee   House work  Educational level   Undergraduate   Diploma   University degree Clinical  Burn reason   Self-inflicted   Event   Criminal  Burn factor   Scald   Flame   Electricity  Burn locations   Face, yes   Hand, yes   Foot, yes   Back, yes   Chest, yes   Genital, yes  Burn degree   1–2   2   2–3   1-2-3  TBSA

Music (n = 50) No. (%)

Mean (SD)

Control (n = 50) No. (%)

31.08 (8.11) 19 (38.00) 31 (62.00)

19 (38.00) 31 (62.00)

21 (42.00) 29 (58.00)

25 (50.00) 25 (50.00)

7 (14.00) 32 (64.00) 11 (22.00)

10 (20.00) 31 (62.00) 9 (18.00)

24 (48.00) 14 (28.00) 10 (20.00)

26 (52.00) 16 (32.00) 10 (20.00)

0 (0.00) 49 (98.00) 1 (2.00)

2 (4.00) 47 (94.00) 1 (2.00)

5 (10.00) 33 (66.00) 12 (24.00)

9 (18.00) 29 (58.00) 12 (24.00)

22 (44.00) 49 (90.00) 37 (74.00) 10 (20.00) 33 (66.00) 0 (0.00)

27 (54.00) 41 (82.00) 45 (90.00) 8 (16.00) 34 (68.00) 1 (2.00)

10 (20.00) 3 (6.00) 21 (42.00) 16 (32.00)

5 (10.00) 6 (12.00) 24 (48.00) 15 (30.00)

Mean (SD)

Sig.

31.18 (8.43)

.95* .58†

.59†

.69†

.80†

.13†

.71†

24.08 (9.68)

.42† .39‡ .06‡ .79‡ .98‡ 1.00‡ .41†

23.02 (9.48)

.58*

*Independent t-test. †χ2 test. ‡Fisher’s exact test.

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Journal of Burn Care & Research Volume XXX, Number XXX

Najafi Ghezeljeh et al  5

and respiration problems. In both groups, most of the patients experienced second to third degree of burn, flame was most common reason of burning, and none of them had been previously hospitalized for burn injury. The mean (SD) of the TBSA was 23.02 (SD = 9.48, ranged from 15 to 47) and 24.08 (SD = 9.68, ranged from 15 to 45) in control and music intervention groups, respectively. Furthermore, the results showed no significant differences between mean scores of all the demographic and clinical variables in the experimental and control groups. Baseline patient demographics and clinical characteristics were similar in both groups. Data showed that before music intervention, burn patients experienced greater pain level with total mean (SD) of 79.58 (18.34). Also patients were generally high anxious with total mean score of 83.53 (17.19). Burn patients were less relax with total mean (SD) of 84.95 (16.66). The mean scores of pain, anxiety, and relaxation levels and physiologic measures in both music and control groups are shown in Table 2. According to the paired t-test, there were statistically significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels before and after music intervention in experimental

group. The results demonstrated no significant differences between mean scores of pulse rate (P = .65), respiration (P = .97), systolic blood pressure (P = .08), and diastolic blood pressure (P = .47) before and after music intervention. Also, the results showed no significant differences between mean scores of all the variables before and after intervention in the control group (Table 2). Moreover, the independent t-test demonstrated that there was a significant difference between mean scores of pain level before the intervention with the music group mean (SD) of 72.00 (19.52) and the control group mean (SD) of 87.17 (13.47) (P < .001). Anxiety level before the intervention differed significantly with the experimental group mean score of 76.30 (18.04) and the control group mean score of 90.77 (12.84) (P < .001). Before the music intervention, there was a significant difference between the mean scores of relaxation level (P < .001) in music and control groups. Moreover, the independent t-test demonstrated that there were significant differences between mean scores of pain (P < .001), anxiety (P < .001), and relaxation (P < .001) levels and respiration rate (P < .001) in music and control groups before intervention. Comparison of the pulse rate, systolic blood

Table 2. Mean scores of participants’ pain, anxiety, and relaxation levels and physiologic measures in music and control groups Groups Variables Pain

Anxiety

Relaxation

Pulse rate

Respiration rate

Systolic blood pressure

Diastolic blood pressure

Music (N = 50)

Control (N = 50)

Time

Mean (SD)

Mean (SD)

Tests Result*

Before After Test result† Before After Test result† Before After Test result† Before After Test result† Before After Test result† Before After Test result† Before After Test result†

72.00 (19.52) 42.80 (23.76) t = 13.39, P < .001 76.30 (18.04) 30.60 (20.89) t = 20.34, P < .001 77.70 (17.33) 26.89 (18.68) t = 25.26, P < .001 79.82 (8.12) 79.69 (7.52) t = 0.45, P = .65 20.80 (4.45) 20.79 (5.17) t = 0.04, P = .97 118.13 (9.79) 118.77 (9.52) t = −1.80, P = .08 70.21 (6.72) 69.96 (6.43) t = 0.73, P = .47

87.17 (13.47) 88.20 (17.69) t = −0.91, P = .37 90.77 (12.84) 89.96 (17.41) t = 0.68, P = .50 92.20 (12.37) 90.23 (18.34) t = 1.49, P = .14 79.69 (7.51) 79.73 (7.28) t = −0.18, P = .86 23.85 (3.13) 24.22 (3.04) t = −3.47, P = .001 121.48 (26.62) 115.60 (10.94) t = 1.73, P = .09 68.41 (4.35) 68.64 (4.51) t = −1.22, P = .23

t = −4.52, P < .001 t = −10.83, P < .001 t = −4.62, P < .001 t = −15.44, P < .001 t = −4.82, P < .001 t = −17.11, P < .001 t = 0.08, P = .93 t = −0.02, P = .98 t = −3.96, P < .001 t = −4.04, P < .001 t = −0.83, P = .41 t = 1.54, P = .12 t = 1.18, P = .23 t = 1.58, P = .11

*Independent t-test. †Paired t-test.

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Table 3. Mean scores of changes in participants’ pain, anxiety, and relaxation levels and respiration rate before and after intervention in music and control groups Groups Variables Pain Anxiety Relaxation Respiration rate

Music (N = 50)

Control (N = 50)

Mean (SD)

Mean (SD)

Sig.*

−29.20 (15.42) −45.70 (15.89) −50.81 (14.22) −0.01 (2.53)

1.03 (8.07) −0.80 (8.35) −1.97 (9.34) 0.37 (0.76)

t = −12.28, P < .001 t = −17.69, P < .001 t = −20.30, P < .001 t = −1.03, P = .31

*Independent t-test.

pressure, and diastolic blood pressure between the two groups before the music intervention did not demonstrate any significant differences. After the intervention, pain level also differed significantly with the music group mean (SD) of 42.80 (23.76) and the control group mean (SD) of 88.20 (17.69) (P < .001). After the music intervention, there was a significant difference between the mean scores of anxiety (P < .001) level in experimental and control groups. Relaxation level after the intervention differed significantly with the music group mean (SD) of 26.89 (18.68) and the control group mean of 90.23 (18.34) (P < .001). Also, results showed that there was a statistically significant difference between the mean scores of respiration rate in experimental and control groups (P < .001). According to the results, there were no significant differences between the mean scores of pulse rate and systolic and diastolic blood pressures in both groups after intervention (Table 2). Since before intervention there were significant differences between two groups regarding the mean scores of pain, anxiety, and relaxation levels and respiration rate, mean scores of changes in these variables before and after intervention were considered for comparing groups (Table 3). Independent t-test indicated a significant difference between the mean scores of changes in pain level before and after intervention in music and control groups (P < .001). Also,

results showed that there was a statistically significant difference between the mean scores of changes in anxiety level before and after music intervention in both groups (P < .001). According to the results, there was a significant difference between the mean scores of changes in relaxation level before and after intervention in experimental and control groups (P < .001). No differences in the mean score of changes in respiratory rate was detected between music and control groups (P = .31). According to the results, in initial day, there were not statistically significant differences between music and control groups regarding the type (P = .19) and the amount of opioid (P = .49) and nonopioid (P = .21) analgesics used. As a result, the significant reduction in patients’ pain level and their use of analgesics in experimental group as compared with control group was secondary to music intervention. Moreover, the average use of analgesics in 3 days is presented in Table 4. The results of Fisher’s exact test indicated a significant difference between music and control groups in the type of analgesics used (P < .001). Independent t-test showed a statistically significant difference between the mean scores of the amount of opioid analgesics used in music and control groups (P < .001). Comparison of the amount of nonopioid analgesics used did not show significant differences between the two groups.

Table 4. Analgesic use of burn patients in 3 days of intervention in music and control groups Groups Analgesic Use Type  Opioid  Nonopioid  Both Opioid amount, mg Nonopioid amount, mg

Music (N = 50) No. (%)

Mean (SD)

Control (N = 50) No. (%)

Sig.

Mean (SD)

The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest ...
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