Abstract
Introduction:
Music interventions can alleviate patient anxiety and improve post-surgical satisfaction. However, it remains uncertain whether personal music preferences affect efficacy. The authors tested whether personal music intervention with patient-selected songs played ad libitum is more effective than standard therapist-designed treatment with classical music.
Methods:
A prospective, parallel-group, single-blinded, randomized controlled trial with 229 participants (aged 18–60 years) previously scheduled for elective surgery. Data analyses followed a modified intention-to-treat principle. The patients were randomized into three groups: Standard care without music (Control), therapist-designed classic music treatment (TT), or personal music intervention with patient-selected songs played ad libitum by the patient (PI). All patients received standard post-anaesthesia care, and music intervention was started upon arrival at the post-anaesthesia care unit. Primary outcomes were anxiety and overall satisfaction at discharge. In contrast, secondary outcomes were systolic blood pressure during music intervention, the sleep quality of the night after surgery, and the occurrence of postoperative nausea and vomiting within the first 24 h after surgery.
Results:
Compared with therapist-designed music treatment, personal intervention decreased systolic blood pressure (T0: 124.3±13.7, 95% CI:121–127.7; T20min: 117.6±10.4, 95% CI:115–120.1; T30min: 116.9±10.6, 95% CI:114.3–119.4), prevented postoperative nausea and vomiting (Control: 55.9%, TT: 64.6%, PI: 77.6%), including severe postoperative nausea (VAS score>4; Control: 44.1%; TT: 33.8%; PI: 20.9%) and severe emesis (Frequency≥3, Control: 13.2%; TT: 7.7%; PI: 4.5%). None of the treatments affected sleep quality at night after surgery (Median, Q1–Q3, Control: 3, 1–3; TT: 3, 1–4; PI: 3, 1–3.5). Personal, but not therapist, music intervention significantly prevented anxiety (Control: 36.4±5.9, 95% CI:35.0–37.9; TT: 36.2±7.1, 95% CI: 34.4-37.9; PI: 33.8±5.6, 95% CI: 32.4–35.2) and emesis (Control: 23.9%; TT: 23.4%; PI: 13.2%) and improved patient satisfaction (Median, Q1–Q3, C: 8, 6–8; TT: 8, 7–9; PI: 8, 7–9).
Conclusions:
Personal music intervention improved postoperative systolic blood pressure, anxiety, nausea, emesis, and overall satisfaction, but not sleep quality, as compared to therapist-designed classic intervention.
Keywords: anxiety, music medicine, surgery, surgical outcome
Introduction
Highlights
A prospective, parallel-group, single-blinded, randomized controlled trial with 229 participants (aged 18–60 years) to compare personal music intervention with patient-selected songs played ad libitum by the patient to therapist-designed classic music treatment and control patients with Standard care without music.
Primary outcomes were anxiety and overall satisfaction at discharge, whereas secondary outcomes were systolic blood pressure during music intervention, sleep quality of the night after surgery, and the occurrence of postoperative nausea and vomiting within the first 24 h after surgery.
Personal music intervention improved postoperative systolic blood pressure, anxiety, nausea, emesis, and overall satisfaction as compared to both therapist-designed classic interventions.
Personal music intervention, but not therapist-designed music treatment, prevented emesis 24 h post-surgery compared to the control.
Neither personal music intervention nor therapist-designed classic treatment improved postoperative sleep quality compared to control.
The CDC estimated that more than 105 million surgeries were performed in the United States in 2022, with a projected annual growth rate of 3%1. Outpatient surgery has major clinical advantages, including reduced risk of nosocomial infections, faster recovery, and greater patient satisfaction2–7. Major factors limiting outpatient surgery include patient anxiety, which directly impacts pain susceptibility, cardiovascular performance, and patient anxiety/dissatisfaction8–10. Anxiety and pain directly impact patient satisfaction and are routinely treated with anxiolytics and opioids11–13. Analgesics are less effective in patients with higher anxiety, and opioids have detrimental side effects and are addictive14. Meta-analysis studies have reported that 40% of surgical patients still had moderate-to-severe pain after their first analgesic dose, 75% reported pain after discharge, and 80% of patients treated with opioids experienced adverse effects15. Nearly 5% of surgical patients continue using opioids 90 days after discharge16. With nearly 100 000 opioid-related deaths in 2022 in the United States17, the National Institutes of Health (NIH) have established the NIH-HEAL initiative to urgently develop complementary treatments to reduce opioid use without compromising pain relief and patient satisfaction18,19.
Meta-analyses of nearly 100 randomized controlled trials have shown that music alleviates postoperative anxiety and decreases opioid use as compared to usual care without music or white noise20–26. We reported how these studies consistently show that music mitigates anxiety, and most trials point toward a ‘moderate’ but statistically significant effect according to the Cohen guidelines27. However, perioperative music medicine has not been implemented so far because music treatment efficacy remains controversial depending on the intervention and evaluation methods23,26,28–34. Clinical results are mostly conflicting about physiological responses such as blood pressure and vomiting24–26. Music interventions include Music Medicine, listening to pre-recorded music, and Music Therapy, which is a cognitive rehabilitation method involving a systematic treatment with a trained music therapist through personally tailored music experiences, including listening, composing, or playing musical instruments35–37. This classification evidences the critical implications of patient emotional preferences. However, most perioperative interventions are therapist-designed playlists with insufficient information about the music selection except the general music styles (classical, gospel, etc.), where songs significantly differ within playlists and have different emotional implications for patients. Despite these considerations, it remains unknown whether personal music interventions can improve treatment efficacy. Here, we report a prospective, randomized controlled trial comparing personal music intervention (PI) to standard therapist-designed (TT) and control treatment. Personal music intervention refers to patient-selected songs played ad libitum to evoke personal relaxing memories. Therapist treatment refers to a therapist-designed standard classic intervention of 30 min pre-recorded Mozart K448 sonata started upon arrival to the post-anaesthesia care unit (PACU). Our results show that personal music intervention upon arrival to PACU alleviated postoperative anxiety, nausea, vomiting, and improved blood pressure and patient satisfaction compared to therapist and control treatments.
Methods
Study design
The clinical protocol was approved by the IRB of our University and inscribed in the Clinical Trials Register on 3 October 2020, before patient enrolment from January to October 2021. All patients were of the cognitive capacity to understand the informed consent and voluntarily signed the informed consent. This study is reported according to the Consolidated Standards of Reporting Trials (CONSORT)38. Supplemental Digital Content 1, http://links.lww.com/JS9/C272.
Two hundred and twenty-nine (229) patients (18–60 years of age, BMI 18–28 kg/m2) were assessed for eligibility, of whom 203 patients were randomly assigned with a computer-generated random code into either control patients with standard PACU care without music (Control, n=68), or therapist-designed treatment (TT, n=68) or personal music intervention (PI, n=67, Fig. 1). Patients were not approached if they were: expected to remain ventilated after surgery, had uncontrolled hypertension or hyperglycaemia; had preexisting vestibular disorder, epilepsy, or Parkinson’s disease; received emetogenic anticancer therapy in the previous 4 weeks, or presented a history of dizziness. The patients were screened 7–14 days before surgery during pre-anaesthesia evaluation. Anaesthesia was induced with sufentanil 0.5 μg/kg, propofol 2 mg/kg, and rocuronium 0.7 mg/kg. Intubation was performed 2–3 min after rocuronium injection when the BIS value dropped to 40–60. Anaesthesia was maintained during surgery with propofol 4 mg·kg−1·h−1, remifentanil 10 μg·kg−1·h−1, and sevoflurane 0.5–1 MAC. Flurbiprofen axetil 50 mg was given during wound suture.
Figure 1.
Patient flowchart. The diagram shows the (CONSORT) of subject disposition through the enrolment, allocation, and analysis according to the guidelines. Two hundred twenty-nine (229) patients were assessed, and 203 patients were randomly allocated in three experimental groups: (C) control patients with standard PACU care without music (n=68), (TT) therapist-designed 30 min music intervention (n=68), and (PI) personal music intervention (n=67) upon arrival to PACU. The study was completed by 186 subjects, 63 controls, 60 with therapist’s treatment, and 61 with personal music intervention. CONSORT, Consolidated Standards of Reporting Trials diagram; PACU, post-anaesthesia care unit; PONV, postoperative nausea and vomiting; SBP, systolic blood pressure.
Assessments
Clinical endpoints were blood pressure at PACU, anxiety, and patient satisfaction at discharge at 6 h post-surgery, sleep quality, and postoperative nausea and vomiting (PONV) during the 24 h following surgery. Device monitoring data in PACU was automatically recorded by the electronic medical record system. Anxiety was assessed with the two standard State and Trait Anxiety Inventory Subscale anxiety tests (STAI, Spielberger). T-anxiety evaluates general states of calmness, confidence, and security39, and was assessed during pre-anaesthesia evaluation. S-Anxiety evaluates the state of anxiety assessed at discharge (Supp. Fig. 1, Supplemental Digital Content 2, http://links.lww.com/JS9/C273). Patient average sleep quality before surgery was evaluated during the pre-anaesthesia evaluation using the Pittsburgh sleep quality index (PSQI); sleep quality on the night after surgery was assessed by patients using the QON five-grade (1=very bad, 5=very good) scoring. Postoperative nausea and vomiting were evaluated on a 10-point verbal scale (0=no nausea, 10=worst nausea imaginable). Patient satisfaction was assessed on a 10 cm vertical line, labelled at the bottom “not satisfied at all” and the top with “very satisfied”.
Statistical analysis
Sample size (N) was based on preliminary results analyzing postoperative anxiety in personal intervention and therapist-designed music treatment and was calculated with the G*Power3.1 software using ANOVA (Fixed effects, omnibus, one-way), assuming an effect size of 0.25, α=0.05, power (1-beta err prob)=0.8, and number of groups (n)=3. These calculations established N=159 patients for the three groups. Considering a 15–20% attrition rate loss to follow-up, the study required a total of 170–210 patients. SPSS17 (SPSS Inc.) and GraphPadPrismV9 (GraphPad Software) were used for statistical analysis and plot graphs, respectively. Statistical significance was established at P less than or equal to 0.05 with a 2-sided alpha, according to Cohen28. Normal distribution was determined using the Shapiro–Wilk test and reported as mean±SD with 95% CI, and comparison among groups was analyzed with one-way ANOVA and Tukey’s multiple comparisons test. Non-normal distributed variables were reported as median with IQR range (Q1–Q3) and analyzed using the Kruskal–Wallis test with Dunn’s multiple comparison test. Postoperative nausea and vomiting were analyzed with Pearson’s χ2 test. Blood pressure at different time points at PACU was compared among groups using two-way ANOVA with Tukey’s multiple comparisons. Outcome assessors were blinded to group allocation, and data analyses followed a modified intention-to-treat principle.
Results
Disposition and demographics of the patient population
Of the 229 patients assessed for eligibility, 11 patients did not meet the inclusion criteria because of either uncontrolled hypertension, hyperglycaemia, or preexisting vestibular disorder, and the other 15 patients declined participation. Demographic characteristics were well balanced among the groups for age, sex, BMI, and normal distribution of the American Society of Anesthesiologists (ASA) physical status (Table 1). Preexisting conditions (mostly hypertension and diabetes) and surgical procedures were also balanced among groups. Most patients completed the intervention except for 2 patients who discontinued the therapist-designed music treatment. One hundred eighty-four (184) patients completed the study with a similar distribution of 4–6 patients/group lost to follow-up for postoperative sleep quality or patient satisfaction (Fig. 1).
Table 1.
Demographic characteristics of the participants.
| Variables | All participants N=203 | Control N=68 | TT N=68 | PI N=67 |
|---|---|---|---|---|
| Age year, mean (SD) | 46.2 (5.7) | 46.2 (4.8) | 46.5 (6.0) | 45.9 (6.4) |
| Sex male, n (%) | 91 (44.8) | 33 (48.5) | 30 (44.1) | 28 (41.7) |
| Body mass index (kg/m2) | 23.4±2.5 | 23.1±2.0 | 23.6±2.6 | 23.4±2.8 |
| ASA physical status, n (%) | ||||
| I | 32 (15.7) | 9 (13.2) | 11 (16.2) | 12 (17.9) |
| II | 130 (64) | 44 (64.7) | 45 (66.2) | 41 (61.2) |
| III | 41 (20.2) | 15 (22.1) | 12 (17.7) | 14 (20.9) |
| Comorbidities | ||||
| Hypertension, n (%) | 40 (19.7) | 14 (20.6) | 11 (16.2) | 15 (22.4) |
| Diabetes, n (%) | 16 (7.9) | 7 (10.3) | 5 (7.4) | 4 (6) |
| Type of surgery, n (%) | ||||
| General surgery | 105 (51.7) | 36 (52.9) | 33 (48.5) | 36 (53.7) |
| Thyroidectomy | 45 (22.2) | 15 (22.1) | 14 (20.6) | 16 (23.9) |
| Appendectomy | 30 (14.8) | 11 (16.2) | 9 (13.2) | 10 (14.9) |
| Cholecystectomy | 30 (14.8) | 10 (14.7) | 10 (14.7) | 10 (14.9) |
| Knee arthroscopy, n (%) | 50 (24.6) | 16 (23.5) | 18 (26.5) | 16 (23.9) |
| Middle-ear surgery, n (%) | 48 (23.7) | 16 (23.5) | 17 (25) | 15 (22.4) |
Disposition and demographics of patient population. Patient demographic baseline characteristics by age, sex, BMI, American Society of Anesthesiology physical status, type of surgery, and prevalence of the comorbidities hypertension and diabetes. Nominal variables are shown as the number of patients, with the percentage in parentheses. Continuous variables are shown as the median, with quartiles in parentheses. The anesthesiologist who performed the preoperative examination determined the presence or absence of each comorbidity by asking the patient and checking the medicine that the patient was taking. Demographic characteristics were well balanced among the three experimental groups.
ASA, American Society of Anesthesiologists; PI, personal intervention; TT, therapist treatment.
Personal music intervention improved blood pressure recovery
Systolic blood pressure (SBP) normally presents a linear correlation with cardiovascular events and is consistently associated with cardiovascular disorders40,41. SBP was recorded by the electronic medical record system reporting patients with similar SBP of 120 + 5 mmHg at arrival to PACU (Fig. 2). The mean values of each group were analyzed at different time points to generate a linear regression. Personal intervention induced a steeper negative slope with faster cardiovascular recovery (y=- 0.25x + 124 mmHg) than therapist-designed music treatment (y=-0.17x + 122 mmHg). Personal intervention significantly reduced SBP at 20 (P=0.006) and 30 min (P=0.002) as compared to the other interventions.
Figure 2.
Systolic blood pressure upon patient arrival to PACU. Patient blood pressure was recorded upon arrival to PACU, and systolic pressure measured every 10 min during the music intervention. The mean values of each group at the different time points were analyzed to generate a linear regression for each group: (A) control y=0.126x+114, (B) therapist treatment y=-0.168x+122, and (C) personal music intervention y=-0.253x+124. Diagrams represent mean value±SEM, ## P<0.05 vs. control SBP (n=64–67/group, three groups, Two-way ANOVA). BP, blood pressure; PACU, post-anaesthesia care unit.
Personal intervention, but not therapist treatment, reduced anxiety, and improved patient satisfaction
Anxiety and patient satisfaction were assessed at 6 h just before discharge to avoid loss to follow-up. All groups had similar T-Anxiety scores of 40.6 + 6 anxiety background before surgery (Fig. 3A), but after surgery patients with personal intervention had nearly 10% significantly lower postoperative state of anxiety scores (33.8+5.6; P<0.05) as compared to control patients (36.4+5.9; P<0.05) or therapist-designed music treatment (36.2+7.1; P<0.05; n=67/group, Fig. 3B). Patients with personal intervention also had satisfaction scores significantly higher than the other two groups (Fig. 3C). Therapist-designed music treatment did not improve patient satisfaction as compared to control, whereas personal intervention improved the rate of patients scoring 9–10 by over 20% (P<0.05) as compared to therapist-designed music treatment. Of note, nearly 15% of patients with personal intervention reported the highest satisfaction score of 9–10 as compared to 4% of both control and therapist-designed music treatment patients.
Figure 3.
Patient anxiety and overall satisfaction. (A) Preoperative and (B) postoperative patients’ anxiety scores assessed using the two (STAI, Spielberger): reporting the pre-surgical T-Anxiety “anxiety proneness” including general states of calmness, confidence, and security, and the postoperative S-Anxiety. # P<0.05 post-surgical anxiety levels of patients with personal intervention vs. those with control or therapist’s treatments (n=65 - 68/group, three groups, One-way ANOVA). (C) Violin representation of the overall patient satisfaction on a scale from 0 representing “not satisfied at all” to 10 representing “very satisfied”. ## P<0.01 patients with personal intervention vs. control, and # P<0.05 vs. therapist treatment (n=60–68/group, three groups, Kruskal–Wallis test). S-Anxiety, State Anxiety Scale; STAI, State-Trait Anxiety Inventory tests; T-Anxiety, Trait Anxiety Scale.
None of the interventions improved postoperative sleep quality
Sleep quality of night (QON) versus sleep background before surgery was analyzed during the pre-anaesthesia evaluation. All patient groups had similar Pittsburgh sleep quality index (PSQI) scores (8.6±4.1) before surgery (Supplemental Fig. 2a, Supplemental Digital Content 3, http://links.lww.com/JS9/C274). Postoperative PSQI scores were similar among the groups (2.97+0.8 for C, 3.08+0.8 for therapist-designed music treatment, and 2.9+0.8 for personal intervention; P>0.05, n=67/group). Then, we stratified patients according to their PSQI scores before surgery (Supp Fig. 2b, Supplemental Digital Content 2, http://links.lww.com/JS9/C274). Patients with severely impaired sleep backgrounds appear to benefit the most from personal intervention, but these results were not statistically significant (P>0.05, n=67/group). Although these results were not statistically significant, they suggest that music efficacy could depend on patient sleep background.
Personal music intervention improved postoperative nausea and vomiting incidence (PONV)
The most significant effects (P=0.027, Table 2) of personal intervention were preventing postoperative nausea and vomiting in 77.6% of patients and improving the rate of patients without postoperative nausea and vomiting by more than 20% versus control (55.9%) and therapist-designed music treatment (64.6%), where both nausea and emesis were prevented. The most significant effect (P=0.016) was preventing nausea, where personal intervention was significantly more effective, with only 20.9% of patients reporting severe nausea compared to control (44.1%) and therapist-designed music treatment (33.8%). Personal intervention also prevented emesis in 86.6% of patients compared to similar scores of 77% in both control and therapist-designed music treatment patients (P=0.26). Compared to the control treatment (13.2%), both music treatments reduced severe emesis by 8.7% (personal intervention) and 5.5% (therapist treatment), respectively. Thus, personal intervention was more effective than therapist-designed music treatment at preventing postoperative nausea and vomiting. Personal intervention, but not therapist-designed music treatment, prevented emesis 24 h post-surgery compared to the control.
Table 2.
Incidence of PONV in 24-h postoperative period.
| Control n=68, n (%) | Therapist n=65, n (%) | Personal n=67, n (%) | P | |
|---|---|---|---|---|
| No PONV | 38 (55.9)a | 42 (64.6)ab | 52 (77.6)b | 0.027 |
| Emesis | 16 (23.5) | 15 (23.1) | 9 (13.4) | 0.257 |
| Severe nausea (VAS score ≥4) | 30 (44.1)a | 22 (33.8)ab | 14 (20.9)b | 0.016 |
| Severe emesis (frequency≥3) | 9 (13.2) | 5 (7.7) | 3 (4.5) | 0.182 |
Number and rate of patients according to the incidence of PONV, emesis, severe nausea (VAS score ≥ 4), and severe emesis (Frequency ≥ 3).
Each subscript letter denotes a subset of intervention categories whose column proportions do not differ significantly from each other at the 0.05 level.
PONV, postoperative nausea and vomiting; VAS, Visual Analogue Scale.
Discussion
Preventing patient anxiety is anticipated to improve clinical outcomes and patients’ satisfaction, expediting recovery and hospital discharge18,19. Despite the evidence, perioperative music medicine is underestimated in part because it is typically considered a behavioural treatment42–47 with weak guidelines and controversial efficacy depending on the interventions, tests, and patients’ personal preferences26,29,30. While music has long been recognized as an effective treatment to outlet emotions, it is uncertain how to best treat patients. Most perioperative music interventions are standard therapist-designed interventions with therapist-pre-selected playlists. Patients are normally allowed to choose among pre-recorded playlists representing general styles (Classic, Religious/Gospel, Blues/Soul, Jazz), but songs in the same playlist can differ widely, and some songs might evoke negative memories in some patients. The results are so diverse that meta-analyses have not found significant differences between the choices of music (within playlists pre-selected by the therapist)31,48. A recent study has shown that ICU patients with ‘self-initiated’ music treatment designed by a music therapist reduced anxiety and decreased sedative needs compared to patients with noise-abating headphones without music49. A prospective, randomized controlled trial (ClinicalTrials.gov, NCT02732964) of 150 parturients undergoing elective caesarean delivery reported that treatment with pre-selected Mozart music decreased anxiety before caesarean delivery but not patient-selected Pandora music50. To our knowledge, our report is the first randomized controlled trial to compare postoperative personal music intervention, with patient-selected songs played ad libitum by the patient to evoke personal relaxing memories, with therapist-designed representative treatment with classical music.
Although previous studies are conflicting about the effects of preoperative and intraoperative interventions on postoperative outcomes, most studies consistently show significantly lower heart rate and systolic blood pressure immediately after the music intervention31,48,51,52. When compared directly, postoperative interventions appear more effective than preoperative interventions in reducing heart rate and blood pressure right after the intervention53. In line with these findings, a randomized controlled trial reported that opioid requirements were only lower when the music intervention was postoperative rather than intraoperative54. Considering the conscious emotional involvement of the patient’s music preferences, our music intervention was started upon arrival at PACU.
Both personal intervention and therapist-designed music treatment improved postoperative SBP, but personal intervention was more effective than therapist-designed music treatment. Our results are consistent with multiple clinical trials and meta-analyses showing that music therapy significantly decreases SBP (difference in means, −2.63, CI: −3.92 to −1.35, P<0.001), diastolic blood pressure (−1.11, CI: −1.69 to −0.53, P<0.001), and heart rate (−3.42, CI: −5.03 to −1.81, P<0.001) in surgical and ICU patients27,55. However, a systemic review reported that music produced a small reduction in respiratory rate but no in vital and cardiovascular signs in surgical patients56. Again, this potential difference could be due to the intervention and patients’ preferences. These results are clinically relevant because heart rate variability is normally associated with the parasympathetic nervous system, and neuromodulation can alter postoperative outcomes and organ function27. Furthermore, heart rate variability is associated with the cardiac vagal tone but does not correlate with direct measurements of total vagal activity57–59. Thus, our observed differences between respiratory rate, blood pressure, and heart rate may represent different mechanisms of intervention (i.e. personal intervention or therapist-designed music treatment)-dependent vagal modulation. Our results showing that music improves systolic blood pressure are significant given their consistent association with cardiovascular events and cardiovascular disorders40,41. To our knowledge, our study is the first report showing that personal intervention is more effective than therapist-designed music treatment at improving postoperative systolic blood pressure.
We give special attention to patient anxiety because it affects peripheral neuromodulation and causes stress-metabolic reactions, worsening healing and complications15. We show that personal, but not therapist, intervention significantly decreased anxiety. These results agree with the strong association between anxiety and blood pressure, and the multiple clinical studies showing that music can be more effective than prescription drugs in reducing anxiety48. Although most clinical trials point toward a ‘moderate’ but statistically significant effect, music efficacy differs among the studies mostly in those that have used non-standardized tests28. The STAI Spielberger tests are validated and widely used in the clinic. Bradt et al. (2013)26 showed that music significantly reduced around −5.72 units of patient anxiety scores (MD −5.72, 95% CI: −7.27 to −4.17)26. The results were consistent across trials (I²=43%) using STAI as compared to trials using numeric or visual scales with a lower difference of −0.60 units26. A randomized controlled trial showed that preoperative relaxing music was more effective (P<0.001) in reducing anxiety than orally administrated midazolam60, while another trial reported no significant differences between music intervention and intravenous midazolam treatment using the shortened STAI-6 scale54. Anxiety and patient satisfaction impact physiological conditions, including serum cortisol levels, hypertension, tachycardia, delayed wound healing, impaired immune function, increased risk of infection, and delayed hospital discharge61. In our study, the lower anxiety scores in personal intervention patients correlated with patient satisfaction but not with sleep quality. Whereas only personal intervention significantly improved anxiety and patient satisfaction, none of the treatments improved sleep quality. Multiple studies show that information availability and patient involvement in decision-making are critical factors in patient satisfaction62–64; thus, it may not be surprising that patients with self-selected songs played ad libitum had significantly better overall satisfaction than those with therapist-designed music treatment or controls.
One of the most significant effects of personal intervention was preventing postoperative nausea and vomiting within 24 h after surgery (P=0.027). Postoperative nausea and vomiting are common adverse events after surgery with general anaesthesia65, and they increase the risk of surgical wound dehiscence66 and haematoma67. There are significant efforts to prevent nausea and vomiting, including the use of pharmacologic treatments such as dexamethasone68, ondansetron69, and amisulpride70. However, these treatments cause detrimental side effects, and their efficacy is controversial, whereas no side effects have been reported in music interventions. Furthermore, our results are consistent with studies reporting that music can prevent nausea and/or emesis after organ transplantation71 and antineoplastic chemotherapy in patients with breast cancer72. Although, other studies have shown that music failed to prevent nausea and/or emesis in hysterectomy patients73 and children74. These trials concur with our results, showing that therapist treatment failed to prevent emesis in 23% of patients. Personal intervention, but not therapist-designed music treatment, prevented the incidence of emesis in 13.4% of patients, and personal intervention was also significantly better than therapist-designed music treatment at preventing severe nausea and severe emesis.
Finally, our trial has several limitations, including it is a single-centre study. This can be a significant factor in this study because of the cultural differences and the exposure to Mozart’s classical music in different cultures. In addition to cultural background, different clinical practices in different centres might affect music efficacy and patient responses. Another critical limitation of postoperative interventions started upon arrival to PACU is that patients may be in different stages of sedation, and they may have different capabilities to consciously respond to external stimuli. One important factor is that therapist-designed treatment was started upon arrival at PACU, but self-intervention treatment may be affected by sedation, and deeper-sedated patients might have started the self-intervention later. Two recent studies also add complexity to the diverse results in the music studies suggesting that music may not always be beneficial. Music (Turkish folk, music, popular, or art music) intervention in carotid endarterectomy under regional anaesthesia increased intraoperative patient anxiety and did not affect intraoperative and postoperative pain or patient satisfaction75. Whereas patients listening to a preferred Pandora station broadcast during epidural catheter placement in labouring parturients had higher postprocedure anxiety and no improvement in pain or satisfaction; however, patients had a stronger desire for music with future epidural catheter placements76. These results and the potential of music to evoke personal preferences warrant future studies in more personalized music treatments and their preconditioning potential.
Conclusion
This prospective, parallel-group, single-blinded, randomized controlled trial with 229 participants (aged 18–60 years, previously scheduled for elective surgery) compares personal music intervention with 30 min of patient-selected songs played ad libitum by the patient starting upon arrival at the post-anaesthesia care unit to therapist-designed classic music treatment with 30 min pre-recorded Mozart K448 sonata, and control patients with standard care without music. Personal music intervention was more effective than therapist-designed treatment at decreasing postoperative systolic blood pressure and preventing postoperative nausea, vomiting, and severe emesis. Personal, but not therapist, music intervention significantly prevented anxiety and emesis and improved patient satisfaction as compared to control patients. None of the treatments affected sleep quality at night after surgery.
Ethical approval
The clinical protocol was approved by the Anhui Medical University IRB (#PJ2020-17-19); all subjects voluntarily signed the informed consent, and this study was inscribed in the Clinical Trials Register (Chictr.org, #ChiCTR2000040614).
Consent
All patients were of cognitive capacity to understand the informed consent, all subjects voluntarily signed the informed consent.
Source of funding
This work is supported by institutional funding to F.J., Y.L., and E.G. from the Anhui Medical University. L.U. has not received financial compensation for participating in this study.
Author contribution
Y.L., F.J., T.W., S.C.: study design. F.J., T.W., L.H.: music treatment and data collection. L.C., E.G., X.L., L.U.: data analyses, interpretation, discussion, troubleshooting, presentation, and manuscript preparation.
Conflicts of interest disclosure
The authors declare no conflicts of interest.
Research registration unique identifying number (UIN)
This study was inscribed in the Clinical Trials Register (Chictr.org, #ChiCTR2000040614).
Guarantor
Fan Jiang and Luis Ulloa.
Data availability statement
Data collected in this study, including deidentified participant data and a data dictionary defining each field in the dataset, will be made available to investigators upon the publication of the article. Supporting information includes the statistical analyses and informed consent. To protect patient identity and Health Insurance Portability and Accountability Act (HIPAA) regulations, we will share deidentified participant data. Data will be available to researchers whose proposed use of the data has been approved for a specified purpose and according to a signed data access agreement. All information will be available upon request to: Fan Jiang M.D., Ph.D. Center for Perioperative Organ Protection. Department of Anesthesiology. Duke University Medical Center, Durham, NC 27710, USA. Fan.Jiang@Duke.edu. Department of Anesthesiology. The first affiliated hospital of Anhui Medical University. jiangfanmz@163.com.
Provenance and peer review
This article was not invited.
Supplementary Material
Footnotes
Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.
Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s website, www.lww.com/international-journal-of-surgery.
Published online 27 March 2024
Contributor Information
Fan Jiang, Email: jiangfanmz@163.com.
Tingting Wang, Email: 631471076@qq.com.
Liqiong Hu, Email: 729476506@qq.com.
Shangui Chen, Email: 359437879@qq.com.
Lijian Chen, Email: chenlijian77@126.com.
Xuesheng Liu, Email: liuxuesheng@ahmu.edu.cn.
Yao Lu, Email: luyao@ahmu.edu.cn.
Erwei Gu, Email: ay_guew_mz@163.com.
Luis Ulloa, Email: luis.ulloa@duke.edu.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Data collected in this study, including deidentified participant data and a data dictionary defining each field in the dataset, will be made available to investigators upon the publication of the article. Supporting information includes the statistical analyses and informed consent. To protect patient identity and Health Insurance Portability and Accountability Act (HIPAA) regulations, we will share deidentified participant data. Data will be available to researchers whose proposed use of the data has been approved for a specified purpose and according to a signed data access agreement. All information will be available upon request to: Fan Jiang M.D., Ph.D. Center for Perioperative Organ Protection. Department of Anesthesiology. Duke University Medical Center, Durham, NC 27710, USA. Fan.Jiang@Duke.edu. Department of Anesthesiology. The first affiliated hospital of Anhui Medical University. jiangfanmz@163.com.



