Randomized Controlled Trial on the Impact of Music Therapy During Cardiac Catheterization on Reactive Hyperemia Index and Patient Satisfaction: The Functional Change in Endothelium After Cardiac Catheterization, With and Without Music Therapy (FEAT) Study

Abstract: Objectives. To determine the impact of music intervention on endothelial function, hemodynamics, and patient anxiety before, during, and after cardiac catheterization. Background. The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study. Methods. Seventy patients undergoing elective cardiac catheterization were randomized to music therapy (n=36) or no music therapy (n=34). Peripheral arterial tonometry was performed before and after catheterization. A 6 item (24-point scale) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure. Results. Both study groups had similar baseline characteristics, fluoroscopy time, and contrast administration. Reactive hyperemia index (RHI) change was 0.14 ± 0.72 in the music group and 0.30 ± 0.58 in the control group (P=.35). Systolic and diastolic blood pressure (BP) changes did not significantly differ between the two groups (systolic BP change -3.3 ± 17.3 mm Hg vs -2.3 ± 19.4 mm Hg; P=.83 and diastolic BP change -1.9 ± 12.2 mm Hg vs. 2.0 ± 13.4 mm Hg; P=.23). Heart rate changes were also comparable between the two groups (-1 ± 6 beats/min vs -1 ± 7 beats/min; P=.22). Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy (8 [7-11] vs 9 [8-12]; P=.36). Conclusions. In this study, music intervention did not elicit a vasodilator response, did not lower blood pressure or heart rate, and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography. 

J INVASIVE CARDIOL 2014;26(9):437-442

Key words: music, cardiac catheterization, endothelial function, stress, anxiety, hemodynamics

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Cardiac catheterization can cause significant patient distress. Music playback before and during cardiac catheterization has been shown to relieve anxiety and improve patient satisfaction in some studies.^1-4 The anxiolytic and analgesic effects of music have been attributed to: (1) hemodynamic alterations (lowering of heart rate and blood pressure);^5,6 (2) release of endogenous opioids and activation of the dopaminergic system;⁷ and (3) autonomic and endocrine mechanisms.^8-10 Music may promote vasodilation though endorphin-mediated nitric oxide release in the endothelium.^11,12 Classical music, smooth jazz, and relaxation music have all been used in the catheterization laboratory setting to assess improvement in patient anxiety.^1,3 Moreover, hemodynamic measurements have been used to objectively assess the impact of music therapy on physiologic parameters. The extent to which music can increase patient satisfaction and sensation of well-being remains controversial.

Methods to assess endothelial function alterations have been used as a marker of hemodynamic responses to various stimuli.¹³ The assessment of vasodilation by arterial ultrasonography is expensive, highly operator dependent, and has small signal-to noise-ratio.¹⁴ To overcome these limitations, the Endo-PAT 2000 was developed as a non-invasive device designed to record digital pulse waveforms that represented peripheral arterial tone (PAT) signals as a response to reactive hyperemia.¹⁴ Reactive hyperemia measured with the Endo-PAT 2000 system correlated with nitric oxide bioavailability,¹⁵ coronary endothelial dysfunction,¹⁶ and brachial flow-mediated vasodilation.¹⁷ 

Few data exist in the literature regarding the effect of music therapy on endothelial function.^11,18 The FEAT (Functional change in Endothelium after cardiac cAtheterization, with and without music Therapy) study (clinicaltrials.gov identifier: NCT01632670) was designed to determine the impact of music therapy on: (1) reactive hyperemia index change before and after cardiac catheterization; and (2) patient satisfaction. 

Methods

Patients. Patients undergoing clinically-indicated cardiac catheterization were offered participation in the study if they were >18 years old and did not have any significant hearing loss. Patients were then randomized to music therapy or no music therapy. All patients underwent endothelial function assessment both before and after cardiac catheterization. Additionally, a questionnaire to assess patient satisfaction was administered to all patients after the procedure (Figure 1). The study was approved by the institutional review board and all patients provided written informed consent. 

Music therapy. The music therapy used was MusiCure by Niels Eje (slow, relaxing contemporary music composed for therapeutic purposes). The music was played before and during cardiac catheterization using an audio pillow beneath the patient’s head or through a headset. 

Peripheral arterial tonometry and stress questionnaire. Peripheral arterial tonometry was performed using the EndoPAT 2000 device (Itamar Medical, Inc), which has been validated and used previously to assess peripheral arterial tone in other populations.^19-21 Specially designed finger probes were placed on the middle finger of each subject’s hand. These probes comprise a system of inflatable latex air cuffs connected by pneumatic tubes to an inflating device controlled through a computer algorithm. Pulsatile volume changes of the distal digit induced pressure alterations in the finger cuff were sensed by pressure transducers and transmitted to and recorded by the EndoPAT 2000 device. A decrease in the arterial blood volume in the distal fingertip caused a decrease in pulsatile arterial column changes, reflected as a decrease in the measured PAT signal, and vice versa. Blood pressure and heart rate were measured using an automated blood pressure monitor. 

Endothelial function was measured via the reactive hyperemia peripheral arterial tonometry (RH–PAT) index. The RH–PAT set-up has been previously described.^14,22 The RH protocol consisted of a 5-minute baseline measurement, after which a blood pressure cuff on the test arm was inflated to 60 mm Hg above baseline systolic blood pressure or at least 200 mm Hg for 5 minutes. Occlusion of pulsatile arterial flow was confirmed by the reduction of the PAT tracing to zero. After 5 minutes, the cuff was deflated, and the PAT tracing was recorded for a further 6 minutes. The reactive hyperemic index (RHI) was calculated as the ratio of the PAT signal after cuff release compared with baseline, using a computer algorithm to automatically normalize for baseline signal and index to the contralateral arm. 

Stress and anxiety questionnaire. The short State Trait Anxiety Inventory (STAI) questionnaire was used in the study. This is a 6-item questionnaire containing the following items: (1) I feel comfortable; (2) I feel anguished; (3) I feel at ease; (4) I feel nervous; (5) I feel concerned; and (6) Right now I feel good. There is a scale of answers for the patient to choose from, resulting in a total 24-point scale: 1-not at all; 2-somewhat; 3-moderately so; or 4-very much so. 

Moreover, the following question was asked of all patients: “Which of the following effects did the sound environment during the catheterization have on your overall experience of the procedure?” Possible answers were: very positive; positive; neutral; negative; or very negative.

Statistical analysis. Assuming a standard deviation of 0.4 for RHI-PAT²³ and a=0.05, a total of 58 patients (29 per group) were needed to have 80% power to detect a difference of 0.3 between the music and control group. The total number of patients was increased by 20% to a total of 70 patients to compensate for incomplete data measurements in some patients.

Continuous data were presented as mean ± standard deviation (normally distributed data) or median with interquartile range (non-normally distributed data) and compared using the t-test or Wilcoxon rank-sum test, as appropriate. Categorical data were presented as frequencies or percentages and compared using the chi square or Fisher’s exact test, as appropriate. A P-value of <.05 was considered statistically significant. Statistical analyses were performed using JMP version 9.0 (SAS Institute).

Results

Patient population. Between June 2012 to November 2012, a total of 70 patients undergoing elective cardiac catheterization at our institution were enrolled in the FEAT study and randomized to music therapy (n=36) or no music therapy (n=34). The baseline clinical characteristics of the study patients are summarized in Table 1. Mean age was 62±8 years, 34% of the patients had a prior myocardial infarction, 44% had prior percutaneous coronary intervention (PCI), 19% had undergone prior coronary artery bypass graft surgery, and 57% had diabetes. Patients in the music therapy group had higher prevalence of diabetes (72% vs 41%; P=.01), hypertension (97% vs 82%; P=.05), and prior PCI (55% vs 33%; P=.05); clinical characteristics were otherwise similar between the two groups.

Procedural outcomes. Of the 70 patients enrolled in the study, 65 (93%) underwent diagnostic catheterization and 24 (34%) underwent PCI. Median fluoroscopy time and median contrast administration were 8 minutes (range, 5-17 min) and 138 mL (range, 110-248 mL), respectively, and did not significantly differ between the two groups. Overall, RHI increased following catheterization from 1.76 ± 0.59 to 1.97 ± 0.56 (P=.01). The RHI change was 0.22 ± 0.66 for the entire study population and was similar in patients with and without music therapy (0.14 ± 0.72 vs 0.30 ± 0.58; P=.35) (Figure 2). The impact of music on hemodynamic parameters was also similar between the two groups. Systolic blood pressure change was -3.3 ± 17.3 mm Hg in the music therapy group and  -2.3 ± 19.4 mm Hg in the control group (P=.83). The corresponding measurements for diastolic blood pressure change were -1.9 ± 12.2 mm Hg vs 2.0 ± 13.4 mm Hg (P=.23). Both groups showed comparable changes in heart rates post catheterization (-1 ± 6 beats/min in patients with music therapy and -1 ± 7 beats/min in patients without music therapy; P=.22). Patient anxiety, as measured in the STAI questionnaire, was similar in both study groups (8 [range, 7-11] vs 9 [range, 8-12], respectively; P=.36]. Given the baseline imbalance in the prevalence of diabetes between the two study groups, analyses were repeated while stratified for the presence of diabetes (Table 3), yet results remained similar for patients with and without diabetes mellitus.

Discussion

Our study did not demonstrate any significant effect of music therapy during cardiac catheterization on endothelial function, hemodynamics, and patient satisfaction.

The effect of music therapy on patients undergoing cardiac catheterization has been inconsistent in previous studies (Table 4). There are few data on the impact of music on physiologic measurements. In 2001, Hamel et al studied the effects of a 20-minute music intervention in 101 patients awaiting catheterization.²⁴ Although there were reductions in heart rate and blood pressure after music intervention, differences were not statistically significant. A number of previous studies have shown an improvement in anxiety levels in patients who undergo catheterization.^1-4 Those studies measured the subjective stress level experienced by the patients using the STAI questionnaire. However, Nilsson et al failed to demonstrate a significant improvement in pain, anxiety, and discomfort STAI scores in 121 patients exposed to MusiCure versus 117 patients who received usual treatment.²⁵ Similarly, Bally et al reported insignificant reductions in blood pressure, heart rate, and patient anxiety (as measured with the STAI) in 107 patients who underwent coronary angiography at Kingston General Hospital in Ontario, Canada.²⁶ The results of those studies may indicate that music intervention may have a weak impact on physiologic parameters and stress reduction. 

Several factors may explain the lack of effect of music therapy on outcomes. First, the effects of music may be mainly psychological, and physiologic measurements may not be significantly affected. The FEAT study used RHI, blood pressure, and heart rate as markers of sympathetic nerve tone that reflect patient stress and anxiety. These measurements may not be sensitive or specific enough to examine the effect of music on human physiology. Second, the type of music used in our study (MusiCure) may be effective only in some patient subgroups. It has been suggested that different people may have different reactions to different music types.⁸ In addition, some researchers have indicated that patients should be able to adjust music to meet their specific needs according to the circumstances.^24,26 Flexibility in music selection as well as volume adjustment could have a better analgesic and anxiolytic effect in some patients. However, Goertz et al suggested that allowing patients to select their own music led to attenuation of the positive psychological effects of music therapy, a fact that was attributed to increased feeling of patient responsibility.⁴ Another study has shown that patient responses to music are more positive if the music is “patient-centered” (in their case, played from an audio pillow).² Third, the administration of moderate sedation may have decreased a potential effect of music. Fourth, the duration of music therapy may not have been long enough; continuing music therapy after the end of cardiac catheterization might be more beneficial. Fifth, the study may have been underpowered.  

Study limitations. This study has important limitations. Patients could not be blinded to their group assignment, which could introduce bias in the assessment, although blinding was not feasible. The study may have been underpowered. A study with a larger number of patients, especially when allowing flexibility to adjust the music type to their preference, would have more power in examining potential effects of music therapy. 

Conclusion

In our study, music therapy was not associated with eliciting significant changes in RHI (as measured by the Endo PAT 2000 device), blood pressure, or heart rate, and did not improve satisfaction among patients undergoing cardiac catheterization at our center. 

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*Joint first authors.

From the VA North Texas Healthcare System and UT Southwestern Medical Center, Dallas, Texas.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Banerjee reports research grants from Gilead and the Medicines Company; consultant/speaker honoraria from Covidien and Medtronic; ownership in MDCare Global (spouse); intellectual property in HygeiaTel. Dr Brilakis reports consulting honoraria/speaker fees from Sanofi, Janssen, St Jude Medical, Terumo, Asahi, Abbott Vascular, and Boston Scientific; research grant from Guerbet; spouse is an employee of Medtronic. The other authors report no relevant disclosures.

Manuscript submitted October 15, provisional acceptance given January 9, 2014, final version accepted January 23, 2014.

Address for correspondence: Emmanouil S. Brilakis, MD, PhD, Dallas VA Medical Center (111A), 4500 South Lancaster Road, Dallas, TX 75216. Email: esbrilakis@gmail.com