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Effects of music on patients undergoing a C-clamp procedure after percutaneous coronary interventions: A randomized controlled trial
Effects of music on patients undergoing a C-clamp procedure after percutaneous coronary interventions: A randomized controlled trial Moon Fai Chan, PhD, CStat
OBJECTIVE: The study objective was to assess the effect of music on the physiologic and psychologic parameters in patients undergoing application of a C-clamp after percutaneous coronary interventions (PCI). DESIGN: A repeated-measures randomized controlled trial was used. SETTING: The study took place in three intensive care units in Hong Kong. PATIENTS: Sixty-six patients undergoing application of a C-clamp after PCI were recruited. OUTCOME MEASURES: Physiologic parameters were blood pressure, heart rate, respiratory rate, and oxygen saturation. Psychologic parameters were measured using the University of California at Los Angeles universal pain score. INTERVENTION: Patients were randomized to receive 45 minutes of music therapy or 45 minutes of an uninterrupted rest period. Three types of music were used, including Chinese classical music, religious music, and Western classical music that had slow beats and was relaxing. The data were collected from September 2004 to December 2005. RESULTS: In the experimental group there were statistically significant reductions in heart rate (P ⬍ .001), respiratory rate (P ⬍ .001), and oxygen saturation (P ⬍ .001), and a lower pain score (P ⬍ .001) than in the control group. CONCLUSION: Music is a simple, safe, and effective method of reducing potentially harmful physiologic and psychologic responses arising from pain in patients post-PCI undergoing a C-clamp procedure. (Heart Lung® 2007;36:431– 439.)
M
ost percutaneous coronary interventions (PCI) are performed through the femoral artery.1 After local anesthesia and a small skin incision, the artery is punctured using a thinwalled needle with a 1.0 to 1.2-mm outer diameter with or without a central mandril. The sheath remains in place, and the needle is removed and replaced with the guide wire. The balloon-tipped catheter is advanced through the femoral arterial site to the heart.2 The deflated balloon follows the guide wire to the site of blockage. Once it is in
From the Kiang Wu Nursing College of Macau, Macao SAR, China. Reprint requests: Moon Fai Chan, PhD, CStat, Associate Professor, Kiang Wu Nursing College of Macau, Est. Repouso No. 35, Macao SAR, China. 0147-9563/$ – see front matter Copyright © 2007 by Mosby, Inc. doi:10.1016/j.hrtlng.2007.05.003
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position, the balloon is inflated. The balloon places pressure on the vessel, which pushes outward on the artery-blocking plaque, against the arterial wall. This procedure results in the opening of the blocked coronary blood vessels. To prevent reocclusion of the blood vessel, a stent is inserted at the site of blockage.2,3 After the procedure, the sheaths may be left in place for 4 to 6 hours.4 The sheaths serve as a means of ready access to the vessel should there be an abrupt closure or reocclusion.4 To achieve hemostasis, several different methods are used clinically to compress the arterial groin site after removal of the femoral sheath.2,5 C-clamps are capable of replacing manual compression to achieve hemostasis, conserving human resources and reducing the cost of care.2,5 Other methods, such as the angio-seal, a collagen-based plug, may be used to achieve hemostasis; although the latter causes
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less pain and discomfort for the patient, it is much more expensive to use than a C-clamp. Therefore, the C-clamp is still commonly used for patients after PCI in Hong Kong.
C-CLAMP AND PATIENT DISCOMFORT The C-clamp is a device with a C-shaped arm attached to a plate that fits under the patient’s hips. The upper horizontal arm is adjusted so that the clamp is directly above the femoral site. Pressure is immediately applied to the site after sheath removal, and constant pressure is applied until hemostasis is achieved.4 Normally, the time to achieve hemostasis with C-clamp compression is 30 minutes to 1 hour. During compression, patients are not allowed to move to prevent C-clamp displacement that could lead to hematoma formation or massive hemorrhage requiring transfusion or surgical repair. Bed rest, femoral compression, and immobilization are common clinical practices after femoral sheath removal following coronary angiography. However, C-clamp compression and immobilization are often uncomfortable and painful for the patient.2 Pain may lead to the stress response and affect the physical and mental well-being of the patient.6,7 A study by Leeper5 reported that patients felt moderate to extreme discomfort when the Cclamp was used. The physiologic parameters altered in the stress response include heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SPO2), and respiration rate (RR).8 An elevated blood pressure may increase the time needed to achieve hemostasis after removal of the femoral sheath.2 Pain is frequently reported by patients during the use of the C-clamp because of the constant pressure applied to the femoral accesses site.9 Pain stimulates the sympathetic nervous system and causes an increased HR and constriction of the resistance blood vessels, resulting in an increased blood pressure and thus prolonging the time needed to reach hemostasis.10-13
EFFECTS OF MUSIC ON PATIENTS’ PHYSIOLOGIC AND PSYCHOLOGIC PARAMETERS Music is regarded as the composition of sounds that are comprehended by the human brain as enjoyable and expressive.7 For more than 100 years music therapy has been used to promote sleep, decrease anxiety associated with surgery, and facilitate the effects of local anesthesia.8 Listening to
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music results in physical and mental relaxation and may modulate pain perception. It has been reported that an individual can exert control over the sensorydiscriminative component of pain by means of physical and mental relaxation, and by breathing slowly and deeply.11 Seminal research studies examining the therapeutic effects of music were performed in psychiatric patients.14,15 In addition, several studies have documented the relaxing effect of music with reduction of HR, RR, and state anxiety in patients with myocardial infarction.19-21,27-31 Recently, music therapy has been extended to a variety of clinical settings, including intensive care units (ICUs),16 and has been found to be effective in alleviating preoperative anxiety in Chinese12,17,18 and non-Chinese populations.7,8,19 Researchers have shown that music can have a calming effect on patients, altering physiologic parameters and reducing discomfort and reported pain levels, thus decreasing the dosage of the analgesics needed.12,18,19 Lee et al12 found that HR and blood pressure were statistically significantly decreased among participants undergoing a colonoscopy in a music intervention group, whereas those parameters remained unchanged for those in the non-music group. A similar result was reported by Chlan,3 who showed that ventilated patients in a music group had a greater reduction in HR and RR after approximately 40 minutes compared with the non-music group. Salmore and Nelson19 also demonstrated that participants in a music group had lower DBP than those in a control group during a gastrointestinal examination. In addition, a study by Uplike16 showed that music had a relaxing, distracting, and calming effect on patients in an ICU. Music is not harmful to patients, except those with a history of epilepsy.13 In addition, music therapy is not an expensive intervention and can be easily implemented in the clinical setting.27 The risks of using music as an intervention to reduce pain and discomfort are minimal and the costs are low, which means that music therapy has great potential in the clinical setting.6 A study by Fischer14 suggested that music could improve patients’ tolerance during invasive and unpleasant procedures. However, music therapy should not be a part of routine nursing care for all patients before assessing whether or not a patient enjoys music.7 In addition, it is important to assess the effect of music as an intervention in specific patient populations before clinical implementation. The aim of the study was to determine the effect of music on physiologic parameters and a psychologic parameter, namely, the level of pain in pa-
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tients undergoing the application of a C-clamp after PCI. The following null hypotheses were tested: 1. There will be no statistically significant difference in the reduction in physiologic measures (eg, HR, SBP, DBP, RR, and SPO2) between a music intervention group and a control group of patients undergoing the application of C-clamp after PCI. 2. There will be no statistically significant difference in the reduction of a psychologic parameter (pain level) between a music intervention group and a control group of patients undergoing the application of C-clamp after PCI.
METHODOLOGY The design was a repeated-measures randomized controlled trial. The setting was the ICUs of three acute care hospitals in Hong Kong. There were 400 hospital beds and 600 staff in each facility that provided specialist outpatient and inpatient hospital services. Recent studies showed that giving patients a choice of music decreased anxiety, promoted relaxation,14,19 and led to effective treatment.12,18,20 Therefore, the music chosen by the research team was based on three local studies.12,17,21 Relaxing music was defined as primarily low pitched, with a simple and direct musical rhythm, and a tempo of approximately 60 beats per minute.31 Three types of music were used, including Chinese classical music (eg, bamboo flute), religious music (eg, Buddha Bar IV–Tibet), and Western classical music (eg, Mozart Piano Concerto no. 26) that had slow beats and met the criteria of relaxing music. The data were collected from September 2004 to December 2005. The power of the study was estimated on the basis of the primary outcome measure, HR. A twotailed independent t test was used to test for differences between the two groups, and a high effect size (⫽ .679) was chosen on the basis of earlier local studies.12,17,18 The required sample size for each group was 35 (total ⫽ 70) to achieve 80% power at a 5% level of significance.22 The inclusion and exclusion criteria were based on three local studies.12,17,18
Inclusion criteria ●
●
A diagnosis of myocardial infraction, acute coronary syndrome, and/or coronary artery disease in potential subjects. Conscious and alert with Glasgow Coma Scale to 15; 15 is the best condition and 3 is the worst.
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●
● ●
In this study, conscious and alert equaled 15; 4 ⫽ “best eye response,” 5 ⫽ “best verbal response,” and 6 ⫽ “best motor response.”28 Able to communicate, read, and write. Able to speak Cantonese.
Exclusion criteria ● ● ● ● ●
A hearing deficit. History of psychiatric illness. Neurologic disorders. Dying. Cannot give informed consent.
Eighty-two participants were eligible for the study, with 12 refusals because of lack of interest. Seventy participants were randomized to the two study groups (experimental and control) using a random digit randomizer.23 Thirty-five were originally assigned in each group; however, four participants in the experimental group refused to continue, and this resulted in a final sample of 31 experimental and 35 control subjects.
Instrumentation The study instrument was divided into three parts: Part 1. Demographic variables: Age, gender, religion, marital status, educational level, previous experience with application of C-clamp, previous experience of listening to music during application of C-clamp, and medical history were collected at baseline before application of the C-clamp. Part 2. Physiologic parameters: A bedside monitor was used to collect SBP, DBP, HR, SPO2, and RR for each participant. Data were recorded at baseline (before C-clamp use), 15 minutes, 30 minutes, and 45 minutes (before removal of the C-clamp). Part 3. Psychologic parameter: The University of California at Los Angeles (UCLA) universal pain assessment tool was used to determine pain scores.24 This tool is one of the most popular used in clinical settings. It is available in seven languages and is intended to assist health care providers in assessing pain. The UCLA tool consists of an 11-point scale that ranges from 0 (no pain) to 10 (worst pain possible). Data were collected at baseline (before C-clamp use) and 45 minutes later (before removal of the C-clamp). A panel of experts (a nursing officer working in the ICU, senior medical officer, and clinical psychologist) completed a content validity index (CVI) for the UCLA tool. The CVI should be equal to or greater than .85 for an instrument to be considered valid.26 As determined by the expert panel for this study, the CVI of the UCLA was 1.00. In addition, a test–retest
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reliability was conducted. The stability of a tool repeatedly given to the same person should be greater than .8 to achieve an acceptable level.26 Three patients in the ICU were recruited and asked to rate their pain level using the UCLA tool at baseline and 45 minutes later, and the reliability coefficient for this trial using the UCLA tool was .89.
Procedure After random assignment of the participants to groups, baseline data were collected by a nurse researcher. During the C-clamp procedure (⬃45 minutes), participants in the experimental group were provided with an MP3 player with earphones to listen to the music of their choice from a selection of soft, slow music without lyrics. They were able to adjust the volume to their preference and could decide on their choice of music. Physiologic and psychologic data were collected before (baseline) the C-clamp procedure. During the C-clamp procedure, physiologic data were collected at 15-minute intervals, and psychologic data were collected at the end of the intervention (45 minutes). Participants in the control group were provided an uninterrupted rest period, whereas the same physiologic and psychologic data were collected at the same intervals as the experimental group. All of the data collection, including administering the intervention and collecting the data, was carried out by the same researcher.
Ethical considerations Approval was obtained from the ethics committees of the university and the study hospitals. A nurse researcher explained the study to potential participants, and written informed consent was obtained. To ensure confidentiality, the patient’s personal identity was protected and all data were identified only by case number. Participants were told that they could withdraw from the study at any time without adverse consequences on their subsequent care.
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ferences existed for all outcome variables between the two groups at each time point. For physiologic variables, the Friedman test was used to test for any statistically significant changes for each dependent variable among four time points for each group. Multiple comparisons were performed to compare each pair (baseline vs. 15 minutes, baseline vs. 30 minutes, and baseline vs. 45 minutes). For the psychologic variable, the Wilcoxon signed-rank test was used to test for any significant changes between baseline and 45 minutes for each group, and a statistical significance level of P ⬍ .05 was adopted.26
RESULTS Demographic and health history variables The demographic and health data for the 66 participants are presented in Table I. The majority of subjects were aged 75 years or more (n ⫽ 21, 31.8%), followed by ages 65 to 74 years (n ⫽ 19, 28.8%). Seventy-two percent (n ⫽ 48) of the subjects were male, and 92.4% (n ⫽ 61) were married. More than half of the participants had a secondary education or above (n ⫽ 35) and indicated no religious belief (n ⫽ 34, 51.5%). Thirty-one participants (59.1%) had had a C-clamp before, and only three participants (4.5%) had tried music therapy. With regard to their health history, all participants had cardiovascular disease, seven participants (10.6%) had respiratory problems, and 55 participants (83.3%) had hypertension. A chi-square test showed no statistically significant differences between the participants of the experimental and control groups for all demographic and health history variables. In addition, demographic and health history variables were compared to discover any differences between the three hospitals, and no statistically significant differences were observed for all variables. These results ensured the homogeneity of the participants recruited from the three hospitals, which allowed the data to be pooled for analysis.
Physiologic measures Data analysis Descriptive statistics were used to describe the groups’ characteristics. Chi-square and Fisher exact tests were used to examine the differences between the groups on demographic and hospital factors. A Shapiro-Wilk test was used to examine the normality of the physiologic and psychologic parameters.25 The results suggested that nonparametric tests were appropriate. A Mann-Whitney U test was used to determine whether any statistically significant dif-
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To address hypothesis 1, a Mann-Whitney U test was used to determine whether there were statistically significant differences for all physiologic variables between the two groups at each time point. As shown in Table II, for the baseline, 15-minute, 30minute, and 45-minute comparisons of the two groups for each variable, statistically significant differences were found for HR, RR, and SPO2 at 30 minutes and 45 minutes. Statistically significant differences in HR were found in the experimental
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Table I Demographic data of study sample by group Group Total (n ⴝ 66) Variables
Age (y) 35–44 45–54 55–64 65–74 75* Gender Male Female Hospital A B C Marital status Single Married Education level Illiterate Primary Secondary Tertiary or above Religious belief No Yes Catholic Christian Buddhist Try music therapy before Yes No Use C-clamp before Yes No Diseases Respiratory (yes) Hypertension (yes)
Control (n ⴝ 35)
Experimental (n ⴝ 31)
Chi-square test
(%)
2
P value
3 6 8 7 7
(9.7) (19.4) (25.8) (22.6) (22.6)
6.70
.154
(65.7) (34.3)
25 6
(80.6) (19.4)
1.85
.174
11 12 12
(31.4) (34.3) (34.3)
11 9 11
(35.5) (29.0) (35.5)
.23
.891
(7.6) (92.4)
3 32
(8.6) (91.4)
2 29
(6.5) (93.5)
.11
.987*
1 30 20 15
(1.5) (45.5) (30.3) (22.7)
1 15 12 7
(2.9) (42.9) (34.3) (20.0)
0 15 8 8
(.0) (48.4) (25.8) (25.8)
1.63
.653
34 32 12 10 10
(51.5) (48.5) (37.4) (31.3) (31.3)
18 17 9 4 4
(51.4) (48.6) (53.0) (23.5) (23.5)
16 15 3 6 6
(51.6) (48.4) (20.0) (40.0) (40.0)
.05
.817
3.69
.158
3 63
(4.5) (95.5)
0 35
(.0) (100.0)
3 28
(9.7) (90.3)
3.55
.098*
39 27
(59.1) (40.9)
20 15
(57.1) (42.9)
19 12
(61.3) (38.7)
.12
.732
7 55
(10.6) (83.3)
5 29
(14.3) (82.9)
2 26
(6.5) (83.9)
1.06 .01
.433* .998*
n
(%)
n
(%)
6 9 11 19 21
(9.1) (13.6) (16.7) (28.8) (31.8)
3 3 3 12 14
(8.6) (8.6) (8.6) (34.3) (40.0)
48 18
(72.7) (27.3)
23 12
22 21 23
(33.3) (31.8) (34.8)
5 61
n
*Fisher exact test.
group (30 minutes: mean ⫽ 67.5 ⫾ 15.3; 45 minutes: mean ⫽ 65.5 ⫾ 17.1) compared with the control group (30 minutes: mean ⫽ 79.4 ⫾ 10.5, P ⬍ .001; 45 minutes: mean ⫽ 79.8 ⫾ 11.1, P ⬍ .001). Statistically significant differences in RR were found in the experimental group (30 minutes: mean ⫽ 17.2 ⫾
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6.3; 45 minutes: mean ⫽ 18.3 ⫾ 5.5) compared with the control group (30 minutes: mean ⫽ 23.1 ⫾ 7.6, P ⬍ .001; 45 minutes: mean ⫽ 28.9 ⫾ 10.4, P ⬍ .001). Statistically significant differences in SPO2 were found in the experimental group (30 minutes: mean ⫽ 96.7 ⫾ 1.3; 45 minutes: mean ⫽ 95.6 ⫾ 1.6)
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Table II Comparison on outcome measures by groups Group Control (n ⴝ 35) Outcomes
Systolic blood pressure (SBP) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Diastolic blood pressure (DBP) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Heart rate (HR) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Respiratory rate (RR) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Oxygen saturation (SPO2) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* UCLA universal pain assessment tool Baseline 45 min Wilcoxon signed-rank test
Mean (SD)
Median (range)
143.6 (23.4) 147.0 (77.0–184.0) 139.1 (26.6) 138.0 (87.0–208.0) 140.5 (25.0) 138.0 (86.0–210.0) 141.9 (31.0) 143.0 (70.0–200.0) 2 ⫽ 11.23, P ⫽ .011† A (P ⫽ .055), B (P ⫽ .132), C (P ⫽ .974) 73.1 (11.6) 70.4 (13.6) 71.1 (11.5) 68.7 (14.6)
76.0 (48.0–91.0) 72.0 (54.0–97.0) 68.0 (55.0–95.0) 70.0 (46.0–97.0) 2 ⫽ 2.79, P ⫽ .426 A (P ⫽ .297), B (P ⫽ .320), C (P ⫽ .043†)
77.0 (10.8) 78.0 (50.0–100.0) 74.7 (12.7) 77.0 (51.0–104.0) 79.4 (10.5) 78.0 (55.0–104.0) 79.8 (11.1) 78.0 (56.0–106.0) 2 ⫽ 15.76, P ⫽ .001† A (P ⫽ .006†), B (P ⫽ .150), C (P ⫽ .176) 22.5 (6.8) 21.0 (13.0–37.0) 20.3 (4.3) 19.0 (12.0–32.0) 23.1 (7.6) 18.0 (15.0–40.0) 28.9 (10.4) 29.0 (12.0–45.0) 2 ⫽ 22.09, P ⬍ .001† A (P ⫽ .070), B (P ⫽ .281), C (P ⫽ .002) 96.3 (1.7) 97.3 (1.5) 97.6 (1.1) 97.2 (1.3)
97.0 (93.0–99.0) 98.0 (91.0–99.0) 98.0 (95.0–99.0) 98.0 (95.0–99.0) 2 ⫽ 12.62, P ⫽ .006† A (P ⫽ .009†), B (P ⫽ .002†), C (P ⫽ .016†) 2.8 (2.1) 6.3 (3.3)
2.0 (.0–9.0) 7.0 (.0–10.0) Z ⫽ ⫺4.73, P ⬍ .001†
UCLA, University of California at Los Angeles; with Chinese version range from (0) no pain to (10) bed-rest required; the higher the score, the worst pain. *A: baseline versus 15 min; B: baseline versus 30 min; C: baseline versus 45 min. †Significant at P ⬍ .05.
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Table II Continued Group Experimental (n ⴝ 31) Mean (SD)
Median (range)
148.0 (77.0–174.0) 143.0 (87.0–170.0) 132.0 (86.0–163.0) 149.0 (95.0–100.0) 2 ⫽ 24.71, P ⬍ .001† A (P ⫽ .024†), B (P ⬍ .001†), C (P ⫽ .001†)
Mann-Whitney U test U
P value
143.6 (23.9) 137.5 (24.1) 130.7 (21.5) 136.1 (21.2)
486.50 542.50 387.50 473.00
.471 .896 .046† .369
71.7 (11.8) 72.6 (11.9) 70.7 (15.3) 72.7 (12.9)
493.00 467.50 504.00 424.50
.524 .334 .620 .128
72.6 (14.3) 71.3 (14.5) 67.5 (15.3) 65.5 (17.1)
431.50 458.00 265.50 270.00
.153 .277 ⬍.001† ⬍.001†
22.1 (7.3) 18.5 (4.7) 17.2 (6.3) 18.3 (5.5)
484.00 358.00 248.00 206.00
.449 .017† ⬍.001† ⬍.001†
96.3 (1.1) 96.8 (1.3) 96.7 (1.3) 95.6 (1.6)
97.0 (94.0–98.0) 97.0 (95.0–99.0) 97.0 (95.0–100.0) 96.0 (93.0–98.0) 2 ⫽ 22.27, P ⬍ .001† A (P ⫽ .043†), B (P ⫽ .170), C (P ⫽ .012†)
503.00 396.50 313.50 246.50
.602 .053 .002† ⬍.001†
2.9 (3.2) 2.1 (2.7)
518.50 205.00
.753 ⬍.001†
71.0 (48.0–91.0) 75.0 (55.0–97.0) 76.0 (37.0–95.0) 79.0 (50.0–92.0) 2 ⫽ 1.71, P ⫽ .635 A (P ⫽ .875), B (P ⫽ .596), C (P ⫽ .624) 77.0 (46.0–100.0) 76.0 (46.0–104.0) 68.0 (46.0–104.0) 60.0 (40.0–106.0) 2 ⫽ 18.14, P ⬍ .001† A (P ⫽ .210), B (P ⫽ .001), C (P ⫽ .002)
18.0 (15.0–37.0) 18.0 (11.0–32.0) 16.0 (10.0–37.0) 16.0 (12.0–35.0) 2 ⫽ 21.63, P ⬍ .001† A (P ⫽ .002†), B (P ⫽ .001†), C (P ⫽ .001†)
2.0 (.0–10.0) 2.0 (.0–10.0) Z ⫽ ⫺2.05, P ⫽ .041†
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compared with the control group (30 minutes: mean ⫽ 97.6 ⫾ 1.1, P ⫽ .002; 45 minutes: mean ⫽ 97.2 ⫾ 1.3, P ⬍ .001). For each group, the Friedman test was used to determine any statistically significant changes for each physiologic variable among the four time points. For the control group, no statistically significant differences were found for DBP (P ⫽ .426), but statistically significant increases were found for SBP (P ⫽ .011), HR (P ⫽ .001), RR (P ⬍ .001), and SPO2 (P ⫽ .006). For the experimental group, statistically significant reductions were found in SBP (P ⬍ .001), HR (P ⬍ .001), RR (P ⬍ .001), and SPO2 (P ⬍ .001).
Psychologic measure To address hypothesis 2, a Mann-Whitney U test was used to determine whether there were statistically significant differences in patients’ pain scores for the two groups at each time point. As shown in Table II, no differences were found at baseline (P ⫽ .753), but statistically significant differences were found at 45 minutes between the experimental group (mean ⫽ 2.1 ⫾ 2.7) and the control group (mean ⫽ 6.3 ⫾ 3.3, P ⬍ .001). For each group, the Wilcoxon signed-rank test was used to determine any statistically significant difference in the pain score between baseline and 45 minutes. The control group showed a statistically significant increase at 45 minutes (mean ⫽ 6.3 ⫾ 3.3) compared with baseline (mean ⫽ 2.8 ⫾ 2.1, P ⬍ .001). For the experimental group, there was a statistically significant decrease at 45 minutes (mean ⫽ 2.1 ⫾ 2.7) compared with baseline (mean ⫽ 2.9 ⫾ 3.2, P ⫽ .041).
DISCUSSION Haas et al10 and Watkins11 both indicated that music exerts its effect through the entrainment of body rhythms. Entrainment is defined as the tendency for two oscillating bodies to lock into phase and thus vibrate in harmony.3 This is like individual pulsing heart muscle cells that begin pulsing in synchrony when they are brought close together.10,11 When a person is experiencing discomfort, anger, or a stressful situation, their body rhythms (eg, breathing, heart beat, and blood flow) will change.12 Once a person is experiencing stress or anger, adrenaline is released from the adrenal medulla,13 which affects breathing and HR, and leads to a change of blood pressure, RR, HR, and SPO2.6 A study by Haas et al10 showed that a close relationship was found between the musical rhythm and the listener’s
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breathing or respiratory patterns, thus supporting the entrainment hypothesis. An ICU is a stress-laden environment, which may influence physiologic and psychologic patient parameters.12 The results of this study support the beneficial effects of a music intervention in patients undergoing C-clamp compression after PCI. The findings indicate that music can modulate the stressinduced physiologic and psychologic responses of patients during the C-clamp procedure post PCI. The physiologic parameters, including SBP, HR, and RR, were statistically significantly reduced in the experimental group. In addition, there were statistically significant differences at 30 minutes and 45 minutes in the values of HR and RR between the two groups. The experimental group had greater reductions in these values than the control group. We demonstrated that a music intervention could statistically significantly reduce SBP, HR, RR, and SPO2 responses of patients experiencing a C-clamp procedure post-PCI. It should be noted that SPO2 was also reduced in the experimental group; however, this reduction was only a decrease of .7%. This minimal and clinically insignificant decrease in SPO2 may have occurred as the result of the patients feeling more relaxed and experiencing less pain, causing a reduction in the depth and frequency of respirations compared with the control group. It should be noted that the psychologic parameter, mean pain level, experienced by the experimental and control groups at baseline was similar. However, there was a statistically significant higher pain score for the control group compared with the experimental group at 45 minutes. The pain score increased significantly from a mean of 2.8 ⫾ 2.1 to 6.3 ⫾ 3.3 in the control group from baseline to 45 minutes, whereas the pain score declined from a mean of 2.9 ⫾ 3.2 to 2.1 ⫾ 2.7 in the experimental group. In conclusion, a 45-minute music intervention was successful in reducing physiologic and psychologic parameters in a group of Chinese patients undergoing a C-clamp compression procedure postPCI.
STUDY LIMITATIONS The available selection of music included only 15 musical pieces, of which only five were Chinese, thus limiting participant choice. During the intervention, four participants in the experimental group expressed a dislike of the music that they had chosen. They refused to continue to participate and were withdrawn from the study. Therefore, a larger selection of music is recommended in future stud-
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ies. The sample size was small, and a larger study is recommended.
10.
IMPLICATIONS FOR FURTHER RESEARCH
11.
Although previous studies have demonstrated a variety of responses to different kinds of music, no clear definition of the specific types or direction of responses exists.12 As demonstrated in studies by Chlan3 and Yung et al,18 statistically significant differences in RR and HR were found between the music and control groups, whereas no statistically significant differences in HR and RR were found between the music and control groups in studies by Lee et al12 and Wong et al.21 Thus, a systematic review or meta-analysis of all related studies using music as an intervention is recommend to determine its effectiveness on physiologic and psychologic parameters for patients in the ICU setting and from different cultures.
12.
13. 14. 15. 16. 17.
18.
19.
The author thanks S. H. Chan, O. C. Wong, H. L. Chan, M. C. Fong, S. Y. Lai, C. W. Lo, S. M. Ho, S. Y. Ng, S. K. Leung, and S. H. Ko for their data collection, and all the patients who participated in this study.
20. 21.
REFERENCES 1. Brito JC, Junior AA, Oliveira A, Von Sohsten R, Fiho AS, Carvalho H. Transradial approach for coronary interventions. Arq Bras Cardiol 2001;76:374-8. 2. Carere RG, John GW, Christopher EHB, et al. Suture closure of femoral arterial puncture sites after coronary angioplasty followed by same-day discharge. Am Heart J 2000;139:52-8. 3. Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung 1998;27:169-76. 4. Davis C, VanRiper S, Longstreet J, Moscucci M. Vascular complications of coronary interventions. Heart Lung 1997;26: 118-27. 5. Leeper B. Nursing outcomes: percutaneous coronary interventions. J Cardiovasc Nurs 2004;19:346-53. 6. Kneafsey R. The therapeutic use of music in a care of the elderly setting: a literature review. J Clin Nurs 1997;6:341-6. 7. Evans D. The effectiveness of music as an intervention for hospital patents: a systematic review. J Adv Nurs 2002;37: 8-18. 8. Davis WB, Thaut MH. The influences of preferred relaxing music on measures of state anxiety, relaxation and physiological responses. J Music Ther 1989;26:168-87. 9. Pooler-Lunse C, Barkman A, Bock BF. Effects of modified positioning and mobilization on back pain and delayed
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22. 23. 24. 25. 26. 27. 28. 29. 30. 31.
bleeding in patients who received heparin and undergone angiography: a pilot study. Heart Lung 1996;25:117-23. Haas F, Distenfeld S, Axen K. Effects of perceived musical rhythm on respiratory pattern. J Appl Physiol 1986;6:1185-91. Watkins GR. Music therapy: proposed physiological mechanisms and clinical implication. Clin Nurse Spec 1997;11: 43-50. Lee OKA, Chung YFL, Chan MF, Chan WM. The effect of music on the physiological responses and anxiety levels of patients receiving mechanical ventilation: a pilot study. J Clin Nurs 2005;14:609-20. Smolen D, Topp R, Singer L. The effect of self-selected music during colonoscopy on anxiety, hear rate and blood pressure. Appl Nurs Res 2002;16:126-36. Fischer M. Music as therapy. Nursing Times 1990;86:39-41. Hsu WC, Lai HL. Effects of music on major depression in psychiatric inpatients. Arch Psychiatr Nurs 2004;18:193-9. Uplike P. Music therapy results for ICU patients. Dimens Crit Care Nurs 1990;9:39-45. Yung PMB, Szeto CK, Lau BWK, Chan TMF. The effect of music in managing preoperative stress for Chinese surgical patients in the operating room holding area: a controlled trial. Int J Stress Manage 2003;10:64-74. Yung PMB, Szeto CK, French P, Chan TMF. A controlled trial of music and pre-operative anxiety in Chinese men undergoing transurethral resection of the prostate. J Adv Nurs 2002; 39:352-9. Salmore RG, Nelson JP. The effect of pre-procedure teaching, relaxation instruction, and music on anxiety as measured by blood pressures in an outpatient gastrointestinal endoscopy laboratory. Gastroenterol Nurs 2000;23:102-10. Biley FC. The effect on patient well-being of music listening as a nursing intervention: a review of the literature. J Clin Nurs 2000;9:668-77. Wong HLC, Lopez-Nahas V, Molassiotis A. Effects of music on the anxiety in ventilator-dependent patients. Heart Lung 2001;30:367-87. nQuery Advisor. Statistical solutions. Belfast, North Ireland; 2001. December 13, 2006. Research Randomizer, 2005. Available at http://www.randomizer. org/form.htm. UCLA Universal Pain Assessment Tool, 2004. Available at http://www.anes.ucla.edu/pain/assessment_tools.html. Accessed January 23, 2007. Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika 1965;52:591-611. Paulson DS, ed. Multivariate Tests. In: Applied statistical designs for the researcher. Chapter 12. New York: Marcel Dekker, Inc; 2003:564-9. Stevens K. Patients’ perceptions of music during surgery. J Adv Nurs 1990;15:1045-51. Teasdale G, Jennett B. Assessment and prognosis of coma after head injury. Acta Neurochirurgica 1976;34:45-55. Bolwerk C. Effects of relaxing music on state anxiety in myocardial infraction patients. Crit Care Nurs Q 990;13:63-72. Guzetta C. Effects of relaxation and music therapy on patients in a coronary care unit with presumptive acute myocardial infarction. Heart Lung 1989;18:609-61a6. White J. Music therapy: an intervention to reduce anxiety in the myocardial infarction patient. Clin Nurs Spec 1992; 6:58-63.
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OBJECTIVE: The study objective was to assess the effect of music on the physiologic and psychologic parameters in patients undergoing application of a C-clamp after percutaneous coronary interventions (PCI). DESIGN: A repeated-measures randomized controlled trial was used. SETTING: The study took place in three intensive care units in Hong Kong. PATIENTS: Sixty-six patients undergoing application of a C-clamp after PCI were recruited. OUTCOME MEASURES: Physiologic parameters were blood pressure, heart rate, respiratory rate, and oxygen saturation. Psychologic parameters were measured using the University of California at Los Angeles universal pain score. INTERVENTION: Patients were randomized to receive 45 minutes of music therapy or 45 minutes of an uninterrupted rest period. Three types of music were used, including Chinese classical music, religious music, and Western classical music that had slow beats and was relaxing. The data were collected from September 2004 to December 2005. RESULTS: In the experimental group there were statistically significant reductions in heart rate (P ⬍ .001), respiratory rate (P ⬍ .001), and oxygen saturation (P ⬍ .001), and a lower pain score (P ⬍ .001) than in the control group. CONCLUSION: Music is a simple, safe, and effective method of reducing potentially harmful physiologic and psychologic responses arising from pain in patients post-PCI undergoing a C-clamp procedure. (Heart Lung® 2007;36:431– 439.)
M
ost percutaneous coronary interventions (PCI) are performed through the femoral artery.1 After local anesthesia and a small skin incision, the artery is punctured using a thinwalled needle with a 1.0 to 1.2-mm outer diameter with or without a central mandril. The sheath remains in place, and the needle is removed and replaced with the guide wire. The balloon-tipped catheter is advanced through the femoral arterial site to the heart.2 The deflated balloon follows the guide wire to the site of blockage. Once it is in
From the Kiang Wu Nursing College of Macau, Macao SAR, China. Reprint requests: Moon Fai Chan, PhD, CStat, Associate Professor, Kiang Wu Nursing College of Macau, Est. Repouso No. 35, Macao SAR, China. 0147-9563/$ – see front matter Copyright © 2007 by Mosby, Inc. doi:10.1016/j.hrtlng.2007.05.003
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position, the balloon is inflated. The balloon places pressure on the vessel, which pushes outward on the artery-blocking plaque, against the arterial wall. This procedure results in the opening of the blocked coronary blood vessels. To prevent reocclusion of the blood vessel, a stent is inserted at the site of blockage.2,3 After the procedure, the sheaths may be left in place for 4 to 6 hours.4 The sheaths serve as a means of ready access to the vessel should there be an abrupt closure or reocclusion.4 To achieve hemostasis, several different methods are used clinically to compress the arterial groin site after removal of the femoral sheath.2,5 C-clamps are capable of replacing manual compression to achieve hemostasis, conserving human resources and reducing the cost of care.2,5 Other methods, such as the angio-seal, a collagen-based plug, may be used to achieve hemostasis; although the latter causes
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less pain and discomfort for the patient, it is much more expensive to use than a C-clamp. Therefore, the C-clamp is still commonly used for patients after PCI in Hong Kong.
C-CLAMP AND PATIENT DISCOMFORT The C-clamp is a device with a C-shaped arm attached to a plate that fits under the patient’s hips. The upper horizontal arm is adjusted so that the clamp is directly above the femoral site. Pressure is immediately applied to the site after sheath removal, and constant pressure is applied until hemostasis is achieved.4 Normally, the time to achieve hemostasis with C-clamp compression is 30 minutes to 1 hour. During compression, patients are not allowed to move to prevent C-clamp displacement that could lead to hematoma formation or massive hemorrhage requiring transfusion or surgical repair. Bed rest, femoral compression, and immobilization are common clinical practices after femoral sheath removal following coronary angiography. However, C-clamp compression and immobilization are often uncomfortable and painful for the patient.2 Pain may lead to the stress response and affect the physical and mental well-being of the patient.6,7 A study by Leeper5 reported that patients felt moderate to extreme discomfort when the Cclamp was used. The physiologic parameters altered in the stress response include heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SPO2), and respiration rate (RR).8 An elevated blood pressure may increase the time needed to achieve hemostasis after removal of the femoral sheath.2 Pain is frequently reported by patients during the use of the C-clamp because of the constant pressure applied to the femoral accesses site.9 Pain stimulates the sympathetic nervous system and causes an increased HR and constriction of the resistance blood vessels, resulting in an increased blood pressure and thus prolonging the time needed to reach hemostasis.10-13
EFFECTS OF MUSIC ON PATIENTS’ PHYSIOLOGIC AND PSYCHOLOGIC PARAMETERS Music is regarded as the composition of sounds that are comprehended by the human brain as enjoyable and expressive.7 For more than 100 years music therapy has been used to promote sleep, decrease anxiety associated with surgery, and facilitate the effects of local anesthesia.8 Listening to
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music results in physical and mental relaxation and may modulate pain perception. It has been reported that an individual can exert control over the sensorydiscriminative component of pain by means of physical and mental relaxation, and by breathing slowly and deeply.11 Seminal research studies examining the therapeutic effects of music were performed in psychiatric patients.14,15 In addition, several studies have documented the relaxing effect of music with reduction of HR, RR, and state anxiety in patients with myocardial infarction.19-21,27-31 Recently, music therapy has been extended to a variety of clinical settings, including intensive care units (ICUs),16 and has been found to be effective in alleviating preoperative anxiety in Chinese12,17,18 and non-Chinese populations.7,8,19 Researchers have shown that music can have a calming effect on patients, altering physiologic parameters and reducing discomfort and reported pain levels, thus decreasing the dosage of the analgesics needed.12,18,19 Lee et al12 found that HR and blood pressure were statistically significantly decreased among participants undergoing a colonoscopy in a music intervention group, whereas those parameters remained unchanged for those in the non-music group. A similar result was reported by Chlan,3 who showed that ventilated patients in a music group had a greater reduction in HR and RR after approximately 40 minutes compared with the non-music group. Salmore and Nelson19 also demonstrated that participants in a music group had lower DBP than those in a control group during a gastrointestinal examination. In addition, a study by Uplike16 showed that music had a relaxing, distracting, and calming effect on patients in an ICU. Music is not harmful to patients, except those with a history of epilepsy.13 In addition, music therapy is not an expensive intervention and can be easily implemented in the clinical setting.27 The risks of using music as an intervention to reduce pain and discomfort are minimal and the costs are low, which means that music therapy has great potential in the clinical setting.6 A study by Fischer14 suggested that music could improve patients’ tolerance during invasive and unpleasant procedures. However, music therapy should not be a part of routine nursing care for all patients before assessing whether or not a patient enjoys music.7 In addition, it is important to assess the effect of music as an intervention in specific patient populations before clinical implementation. The aim of the study was to determine the effect of music on physiologic parameters and a psychologic parameter, namely, the level of pain in pa-
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tients undergoing the application of a C-clamp after PCI. The following null hypotheses were tested: 1. There will be no statistically significant difference in the reduction in physiologic measures (eg, HR, SBP, DBP, RR, and SPO2) between a music intervention group and a control group of patients undergoing the application of C-clamp after PCI. 2. There will be no statistically significant difference in the reduction of a psychologic parameter (pain level) between a music intervention group and a control group of patients undergoing the application of C-clamp after PCI.
METHODOLOGY The design was a repeated-measures randomized controlled trial. The setting was the ICUs of three acute care hospitals in Hong Kong. There were 400 hospital beds and 600 staff in each facility that provided specialist outpatient and inpatient hospital services. Recent studies showed that giving patients a choice of music decreased anxiety, promoted relaxation,14,19 and led to effective treatment.12,18,20 Therefore, the music chosen by the research team was based on three local studies.12,17,21 Relaxing music was defined as primarily low pitched, with a simple and direct musical rhythm, and a tempo of approximately 60 beats per minute.31 Three types of music were used, including Chinese classical music (eg, bamboo flute), religious music (eg, Buddha Bar IV–Tibet), and Western classical music (eg, Mozart Piano Concerto no. 26) that had slow beats and met the criteria of relaxing music. The data were collected from September 2004 to December 2005. The power of the study was estimated on the basis of the primary outcome measure, HR. A twotailed independent t test was used to test for differences between the two groups, and a high effect size (⫽ .679) was chosen on the basis of earlier local studies.12,17,18 The required sample size for each group was 35 (total ⫽ 70) to achieve 80% power at a 5% level of significance.22 The inclusion and exclusion criteria were based on three local studies.12,17,18
Inclusion criteria ●
●
A diagnosis of myocardial infraction, acute coronary syndrome, and/or coronary artery disease in potential subjects. Conscious and alert with Glasgow Coma Scale to 15; 15 is the best condition and 3 is the worst.
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●
● ●
In this study, conscious and alert equaled 15; 4 ⫽ “best eye response,” 5 ⫽ “best verbal response,” and 6 ⫽ “best motor response.”28 Able to communicate, read, and write. Able to speak Cantonese.
Exclusion criteria ● ● ● ● ●
A hearing deficit. History of psychiatric illness. Neurologic disorders. Dying. Cannot give informed consent.
Eighty-two participants were eligible for the study, with 12 refusals because of lack of interest. Seventy participants were randomized to the two study groups (experimental and control) using a random digit randomizer.23 Thirty-five were originally assigned in each group; however, four participants in the experimental group refused to continue, and this resulted in a final sample of 31 experimental and 35 control subjects.
Instrumentation The study instrument was divided into three parts: Part 1. Demographic variables: Age, gender, religion, marital status, educational level, previous experience with application of C-clamp, previous experience of listening to music during application of C-clamp, and medical history were collected at baseline before application of the C-clamp. Part 2. Physiologic parameters: A bedside monitor was used to collect SBP, DBP, HR, SPO2, and RR for each participant. Data were recorded at baseline (before C-clamp use), 15 minutes, 30 minutes, and 45 minutes (before removal of the C-clamp). Part 3. Psychologic parameter: The University of California at Los Angeles (UCLA) universal pain assessment tool was used to determine pain scores.24 This tool is one of the most popular used in clinical settings. It is available in seven languages and is intended to assist health care providers in assessing pain. The UCLA tool consists of an 11-point scale that ranges from 0 (no pain) to 10 (worst pain possible). Data were collected at baseline (before C-clamp use) and 45 minutes later (before removal of the C-clamp). A panel of experts (a nursing officer working in the ICU, senior medical officer, and clinical psychologist) completed a content validity index (CVI) for the UCLA tool. The CVI should be equal to or greater than .85 for an instrument to be considered valid.26 As determined by the expert panel for this study, the CVI of the UCLA was 1.00. In addition, a test–retest
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reliability was conducted. The stability of a tool repeatedly given to the same person should be greater than .8 to achieve an acceptable level.26 Three patients in the ICU were recruited and asked to rate their pain level using the UCLA tool at baseline and 45 minutes later, and the reliability coefficient for this trial using the UCLA tool was .89.
Procedure After random assignment of the participants to groups, baseline data were collected by a nurse researcher. During the C-clamp procedure (⬃45 minutes), participants in the experimental group were provided with an MP3 player with earphones to listen to the music of their choice from a selection of soft, slow music without lyrics. They were able to adjust the volume to their preference and could decide on their choice of music. Physiologic and psychologic data were collected before (baseline) the C-clamp procedure. During the C-clamp procedure, physiologic data were collected at 15-minute intervals, and psychologic data were collected at the end of the intervention (45 minutes). Participants in the control group were provided an uninterrupted rest period, whereas the same physiologic and psychologic data were collected at the same intervals as the experimental group. All of the data collection, including administering the intervention and collecting the data, was carried out by the same researcher.
Ethical considerations Approval was obtained from the ethics committees of the university and the study hospitals. A nurse researcher explained the study to potential participants, and written informed consent was obtained. To ensure confidentiality, the patient’s personal identity was protected and all data were identified only by case number. Participants were told that they could withdraw from the study at any time without adverse consequences on their subsequent care.
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ferences existed for all outcome variables between the two groups at each time point. For physiologic variables, the Friedman test was used to test for any statistically significant changes for each dependent variable among four time points for each group. Multiple comparisons were performed to compare each pair (baseline vs. 15 minutes, baseline vs. 30 minutes, and baseline vs. 45 minutes). For the psychologic variable, the Wilcoxon signed-rank test was used to test for any significant changes between baseline and 45 minutes for each group, and a statistical significance level of P ⬍ .05 was adopted.26
RESULTS Demographic and health history variables The demographic and health data for the 66 participants are presented in Table I. The majority of subjects were aged 75 years or more (n ⫽ 21, 31.8%), followed by ages 65 to 74 years (n ⫽ 19, 28.8%). Seventy-two percent (n ⫽ 48) of the subjects were male, and 92.4% (n ⫽ 61) were married. More than half of the participants had a secondary education or above (n ⫽ 35) and indicated no religious belief (n ⫽ 34, 51.5%). Thirty-one participants (59.1%) had had a C-clamp before, and only three participants (4.5%) had tried music therapy. With regard to their health history, all participants had cardiovascular disease, seven participants (10.6%) had respiratory problems, and 55 participants (83.3%) had hypertension. A chi-square test showed no statistically significant differences between the participants of the experimental and control groups for all demographic and health history variables. In addition, demographic and health history variables were compared to discover any differences between the three hospitals, and no statistically significant differences were observed for all variables. These results ensured the homogeneity of the participants recruited from the three hospitals, which allowed the data to be pooled for analysis.
Physiologic measures Data analysis Descriptive statistics were used to describe the groups’ characteristics. Chi-square and Fisher exact tests were used to examine the differences between the groups on demographic and hospital factors. A Shapiro-Wilk test was used to examine the normality of the physiologic and psychologic parameters.25 The results suggested that nonparametric tests were appropriate. A Mann-Whitney U test was used to determine whether any statistically significant dif-
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To address hypothesis 1, a Mann-Whitney U test was used to determine whether there were statistically significant differences for all physiologic variables between the two groups at each time point. As shown in Table II, for the baseline, 15-minute, 30minute, and 45-minute comparisons of the two groups for each variable, statistically significant differences were found for HR, RR, and SPO2 at 30 minutes and 45 minutes. Statistically significant differences in HR were found in the experimental
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Table I Demographic data of study sample by group Group Total (n ⴝ 66) Variables
Age (y) 35–44 45–54 55–64 65–74 75* Gender Male Female Hospital A B C Marital status Single Married Education level Illiterate Primary Secondary Tertiary or above Religious belief No Yes Catholic Christian Buddhist Try music therapy before Yes No Use C-clamp before Yes No Diseases Respiratory (yes) Hypertension (yes)
Control (n ⴝ 35)
Experimental (n ⴝ 31)
Chi-square test
(%)
2
P value
3 6 8 7 7
(9.7) (19.4) (25.8) (22.6) (22.6)
6.70
.154
(65.7) (34.3)
25 6
(80.6) (19.4)
1.85
.174
11 12 12
(31.4) (34.3) (34.3)
11 9 11
(35.5) (29.0) (35.5)
.23
.891
(7.6) (92.4)
3 32
(8.6) (91.4)
2 29
(6.5) (93.5)
.11
.987*
1 30 20 15
(1.5) (45.5) (30.3) (22.7)
1 15 12 7
(2.9) (42.9) (34.3) (20.0)
0 15 8 8
(.0) (48.4) (25.8) (25.8)
1.63
.653
34 32 12 10 10
(51.5) (48.5) (37.4) (31.3) (31.3)
18 17 9 4 4
(51.4) (48.6) (53.0) (23.5) (23.5)
16 15 3 6 6
(51.6) (48.4) (20.0) (40.0) (40.0)
.05
.817
3.69
.158
3 63
(4.5) (95.5)
0 35
(.0) (100.0)
3 28
(9.7) (90.3)
3.55
.098*
39 27
(59.1) (40.9)
20 15
(57.1) (42.9)
19 12
(61.3) (38.7)
.12
.732
7 55
(10.6) (83.3)
5 29
(14.3) (82.9)
2 26
(6.5) (83.9)
1.06 .01
.433* .998*
n
(%)
n
(%)
6 9 11 19 21
(9.1) (13.6) (16.7) (28.8) (31.8)
3 3 3 12 14
(8.6) (8.6) (8.6) (34.3) (40.0)
48 18
(72.7) (27.3)
23 12
22 21 23
(33.3) (31.8) (34.8)
5 61
n
*Fisher exact test.
group (30 minutes: mean ⫽ 67.5 ⫾ 15.3; 45 minutes: mean ⫽ 65.5 ⫾ 17.1) compared with the control group (30 minutes: mean ⫽ 79.4 ⫾ 10.5, P ⬍ .001; 45 minutes: mean ⫽ 79.8 ⫾ 11.1, P ⬍ .001). Statistically significant differences in RR were found in the experimental group (30 minutes: mean ⫽ 17.2 ⫾
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6.3; 45 minutes: mean ⫽ 18.3 ⫾ 5.5) compared with the control group (30 minutes: mean ⫽ 23.1 ⫾ 7.6, P ⬍ .001; 45 minutes: mean ⫽ 28.9 ⫾ 10.4, P ⬍ .001). Statistically significant differences in SPO2 were found in the experimental group (30 minutes: mean ⫽ 96.7 ⫾ 1.3; 45 minutes: mean ⫽ 95.6 ⫾ 1.6)
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Table II Comparison on outcome measures by groups Group Control (n ⴝ 35) Outcomes
Systolic blood pressure (SBP) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Diastolic blood pressure (DBP) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Heart rate (HR) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Respiratory rate (RR) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* Oxygen saturation (SPO2) Baseline 15 min 30 min 45 min Friedman test Multiple comparisons* UCLA universal pain assessment tool Baseline 45 min Wilcoxon signed-rank test
Mean (SD)
Median (range)
143.6 (23.4) 147.0 (77.0–184.0) 139.1 (26.6) 138.0 (87.0–208.0) 140.5 (25.0) 138.0 (86.0–210.0) 141.9 (31.0) 143.0 (70.0–200.0) 2 ⫽ 11.23, P ⫽ .011† A (P ⫽ .055), B (P ⫽ .132), C (P ⫽ .974) 73.1 (11.6) 70.4 (13.6) 71.1 (11.5) 68.7 (14.6)
76.0 (48.0–91.0) 72.0 (54.0–97.0) 68.0 (55.0–95.0) 70.0 (46.0–97.0) 2 ⫽ 2.79, P ⫽ .426 A (P ⫽ .297), B (P ⫽ .320), C (P ⫽ .043†)
77.0 (10.8) 78.0 (50.0–100.0) 74.7 (12.7) 77.0 (51.0–104.0) 79.4 (10.5) 78.0 (55.0–104.0) 79.8 (11.1) 78.0 (56.0–106.0) 2 ⫽ 15.76, P ⫽ .001† A (P ⫽ .006†), B (P ⫽ .150), C (P ⫽ .176) 22.5 (6.8) 21.0 (13.0–37.0) 20.3 (4.3) 19.0 (12.0–32.0) 23.1 (7.6) 18.0 (15.0–40.0) 28.9 (10.4) 29.0 (12.0–45.0) 2 ⫽ 22.09, P ⬍ .001† A (P ⫽ .070), B (P ⫽ .281), C (P ⫽ .002) 96.3 (1.7) 97.3 (1.5) 97.6 (1.1) 97.2 (1.3)
97.0 (93.0–99.0) 98.0 (91.0–99.0) 98.0 (95.0–99.0) 98.0 (95.0–99.0) 2 ⫽ 12.62, P ⫽ .006† A (P ⫽ .009†), B (P ⫽ .002†), C (P ⫽ .016†) 2.8 (2.1) 6.3 (3.3)
2.0 (.0–9.0) 7.0 (.0–10.0) Z ⫽ ⫺4.73, P ⬍ .001†
UCLA, University of California at Los Angeles; with Chinese version range from (0) no pain to (10) bed-rest required; the higher the score, the worst pain. *A: baseline versus 15 min; B: baseline versus 30 min; C: baseline versus 45 min. †Significant at P ⬍ .05.
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Table II Continued Group Experimental (n ⴝ 31) Mean (SD)
Median (range)
148.0 (77.0–174.0) 143.0 (87.0–170.0) 132.0 (86.0–163.0) 149.0 (95.0–100.0) 2 ⫽ 24.71, P ⬍ .001† A (P ⫽ .024†), B (P ⬍ .001†), C (P ⫽ .001†)
Mann-Whitney U test U
P value
143.6 (23.9) 137.5 (24.1) 130.7 (21.5) 136.1 (21.2)
486.50 542.50 387.50 473.00
.471 .896 .046† .369
71.7 (11.8) 72.6 (11.9) 70.7 (15.3) 72.7 (12.9)
493.00 467.50 504.00 424.50
.524 .334 .620 .128
72.6 (14.3) 71.3 (14.5) 67.5 (15.3) 65.5 (17.1)
431.50 458.00 265.50 270.00
.153 .277 ⬍.001† ⬍.001†
22.1 (7.3) 18.5 (4.7) 17.2 (6.3) 18.3 (5.5)
484.00 358.00 248.00 206.00
.449 .017† ⬍.001† ⬍.001†
96.3 (1.1) 96.8 (1.3) 96.7 (1.3) 95.6 (1.6)
97.0 (94.0–98.0) 97.0 (95.0–99.0) 97.0 (95.0–100.0) 96.0 (93.0–98.0) 2 ⫽ 22.27, P ⬍ .001† A (P ⫽ .043†), B (P ⫽ .170), C (P ⫽ .012†)
503.00 396.50 313.50 246.50
.602 .053 .002† ⬍.001†
2.9 (3.2) 2.1 (2.7)
518.50 205.00
.753 ⬍.001†
71.0 (48.0–91.0) 75.0 (55.0–97.0) 76.0 (37.0–95.0) 79.0 (50.0–92.0) 2 ⫽ 1.71, P ⫽ .635 A (P ⫽ .875), B (P ⫽ .596), C (P ⫽ .624) 77.0 (46.0–100.0) 76.0 (46.0–104.0) 68.0 (46.0–104.0) 60.0 (40.0–106.0) 2 ⫽ 18.14, P ⬍ .001† A (P ⫽ .210), B (P ⫽ .001), C (P ⫽ .002)
18.0 (15.0–37.0) 18.0 (11.0–32.0) 16.0 (10.0–37.0) 16.0 (12.0–35.0) 2 ⫽ 21.63, P ⬍ .001† A (P ⫽ .002†), B (P ⫽ .001†), C (P ⫽ .001†)
2.0 (.0–10.0) 2.0 (.0–10.0) Z ⫽ ⫺2.05, P ⫽ .041†
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compared with the control group (30 minutes: mean ⫽ 97.6 ⫾ 1.1, P ⫽ .002; 45 minutes: mean ⫽ 97.2 ⫾ 1.3, P ⬍ .001). For each group, the Friedman test was used to determine any statistically significant changes for each physiologic variable among the four time points. For the control group, no statistically significant differences were found for DBP (P ⫽ .426), but statistically significant increases were found for SBP (P ⫽ .011), HR (P ⫽ .001), RR (P ⬍ .001), and SPO2 (P ⫽ .006). For the experimental group, statistically significant reductions were found in SBP (P ⬍ .001), HR (P ⬍ .001), RR (P ⬍ .001), and SPO2 (P ⬍ .001).
Psychologic measure To address hypothesis 2, a Mann-Whitney U test was used to determine whether there were statistically significant differences in patients’ pain scores for the two groups at each time point. As shown in Table II, no differences were found at baseline (P ⫽ .753), but statistically significant differences were found at 45 minutes between the experimental group (mean ⫽ 2.1 ⫾ 2.7) and the control group (mean ⫽ 6.3 ⫾ 3.3, P ⬍ .001). For each group, the Wilcoxon signed-rank test was used to determine any statistically significant difference in the pain score between baseline and 45 minutes. The control group showed a statistically significant increase at 45 minutes (mean ⫽ 6.3 ⫾ 3.3) compared with baseline (mean ⫽ 2.8 ⫾ 2.1, P ⬍ .001). For the experimental group, there was a statistically significant decrease at 45 minutes (mean ⫽ 2.1 ⫾ 2.7) compared with baseline (mean ⫽ 2.9 ⫾ 3.2, P ⫽ .041).
DISCUSSION Haas et al10 and Watkins11 both indicated that music exerts its effect through the entrainment of body rhythms. Entrainment is defined as the tendency for two oscillating bodies to lock into phase and thus vibrate in harmony.3 This is like individual pulsing heart muscle cells that begin pulsing in synchrony when they are brought close together.10,11 When a person is experiencing discomfort, anger, or a stressful situation, their body rhythms (eg, breathing, heart beat, and blood flow) will change.12 Once a person is experiencing stress or anger, adrenaline is released from the adrenal medulla,13 which affects breathing and HR, and leads to a change of blood pressure, RR, HR, and SPO2.6 A study by Haas et al10 showed that a close relationship was found between the musical rhythm and the listener’s
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breathing or respiratory patterns, thus supporting the entrainment hypothesis. An ICU is a stress-laden environment, which may influence physiologic and psychologic patient parameters.12 The results of this study support the beneficial effects of a music intervention in patients undergoing C-clamp compression after PCI. The findings indicate that music can modulate the stressinduced physiologic and psychologic responses of patients during the C-clamp procedure post PCI. The physiologic parameters, including SBP, HR, and RR, were statistically significantly reduced in the experimental group. In addition, there were statistically significant differences at 30 minutes and 45 minutes in the values of HR and RR between the two groups. The experimental group had greater reductions in these values than the control group. We demonstrated that a music intervention could statistically significantly reduce SBP, HR, RR, and SPO2 responses of patients experiencing a C-clamp procedure post-PCI. It should be noted that SPO2 was also reduced in the experimental group; however, this reduction was only a decrease of .7%. This minimal and clinically insignificant decrease in SPO2 may have occurred as the result of the patients feeling more relaxed and experiencing less pain, causing a reduction in the depth and frequency of respirations compared with the control group. It should be noted that the psychologic parameter, mean pain level, experienced by the experimental and control groups at baseline was similar. However, there was a statistically significant higher pain score for the control group compared with the experimental group at 45 minutes. The pain score increased significantly from a mean of 2.8 ⫾ 2.1 to 6.3 ⫾ 3.3 in the control group from baseline to 45 minutes, whereas the pain score declined from a mean of 2.9 ⫾ 3.2 to 2.1 ⫾ 2.7 in the experimental group. In conclusion, a 45-minute music intervention was successful in reducing physiologic and psychologic parameters in a group of Chinese patients undergoing a C-clamp compression procedure postPCI.
STUDY LIMITATIONS The available selection of music included only 15 musical pieces, of which only five were Chinese, thus limiting participant choice. During the intervention, four participants in the experimental group expressed a dislike of the music that they had chosen. They refused to continue to participate and were withdrawn from the study. Therefore, a larger selection of music is recommended in future stud-
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ies. The sample size was small, and a larger study is recommended.
10.
IMPLICATIONS FOR FURTHER RESEARCH
11.
Although previous studies have demonstrated a variety of responses to different kinds of music, no clear definition of the specific types or direction of responses exists.12 As demonstrated in studies by Chlan3 and Yung et al,18 statistically significant differences in RR and HR were found between the music and control groups, whereas no statistically significant differences in HR and RR were found between the music and control groups in studies by Lee et al12 and Wong et al.21 Thus, a systematic review or meta-analysis of all related studies using music as an intervention is recommend to determine its effectiveness on physiologic and psychologic parameters for patients in the ICU setting and from different cultures.
12.
13. 14. 15. 16. 17.
18.
19.
The author thanks S. H. Chan, O. C. Wong, H. L. Chan, M. C. Fong, S. Y. Lai, C. W. Lo, S. M. Ho, S. Y. Ng, S. K. Leung, and S. H. Ko for their data collection, and all the patients who participated in this study.
20. 21.
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